Succeed

in the new
regulatory landscape
Now is the time
 2009

RAPS
annualconference
&exhibition
13–16 September 2009
Philadelphia
Pennsylvania Convention Center

As the global economy and healthcare product

industry continue to reshape and challenge
us in new ways, now is the time for regulatory
to thrive. Thrive as a dynamic profession that
is driving organizational strategy and sound

to Thrive.
decision making throughout the product lifecycle.
Thrive as individuals performing vital work,
making better healthcare products possible.

Connect
Your ability to develop and implement great
ideas depends largely on the depth and breadth
of your network. Being well-connected is not just
about meeting new faces; it’s about bringing
innovative ideas from outside your organization
and putting them to use.

Grow
With over 2,000 regulatory professionals for
you to connect with, learn from and share ideas
with, the 2009 RAPS Annual Conference &
Exhibition, 13–16 September in Philadelphia,
provides you with the power to grow your
network and knowledge base with vital
connections and information that will benefit
you throughout the year.

It’s about knowledge, but it’s also about

networks. Build yours at the 2009 RAPS Annual
Conference & Exhibition and succeed in the new
regulatory landscape.

Registration is now open.

RAPS.org/ac2009
 Connect!
RAPS.org/ac2009 has everything you need to make the most of your Annual Conference
experience. Sign up for the conference Twitter feed, review the list of related products, let
your colleagues know you are attending through the Annual Conference Facebook page,
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape

find out about not-to-miss conference highlights and much more!

Did you know all of these great
networking activities are included

:: Keynote Address
with your conference registration fee?
• S
 hare new ideas with colleagues during
Table of Contents
the continental breakfasts, lunches,
refreshment breaks and evening
receptions
Schedule at a Glance............................................................................... 3 Jim Collins
Conference Highlights ............................................................................. 3
• Make potential career connections at the Author of best-selling business book Good to Great and
Career Center co-author of Built to Last, Jim Collins is a renowned expert
Preconference Workshops....................................................................... 5
on enduring great companies––how they grow, how they
• Access 100+ new innovative products in attain superior performance, and how good companies can
Session Descriptions................................................................................ 6
the Exhibit Hall become great companies. He is author or co-author of four
books, and his work has been featured in Fortune, The Wall
• Participate in the new interactive Situation Biologics/Biotechnology................................................................. 6 Street Journal, Business Week, Harvard Business Review and Fast Company.
Rooms featuring hot issue regulatory His most recent book, Good to Great: Why Some Companies Make the Leap
topics facilitated by RAPS Fellows Business.................................................................................... 8 …And Others Don’t, has sold three million hardcover copies and has been
translated into 35 languages.
This is your opportunity to make valuable Clinical............................................................................................ 9
professional connections!
Combination Products.................................................................. 11

Compliance and Audits................................................................ 13 :: Thank You to Our Sponsors

Medical Devices and IVDs............................................................ 14

Pharmaceuticals........................................................................... 17

Conference Registration......................................................................... 20

Speakers................................................................................................ 20

Session Leaders..................................................................................... 20
The RAPS Business and Leadership
Series equips you with the tools top
About Philadelphia................................................................................. 21
regulatory managers require. Visit
RAPS.org/business to learn more.
* Sponsors confirmed at press time. Visit RAPS.org/ac2009 for the latest list of sponsors.

2
:: Schedule at a Glance
SATURDAY, 12 SEPTEMBER
4:00–7:00 pm Registration, Speaker Ready Room and Bookstore Open

SUNDAY, 13 SEPTEMBER
7:00–8:30 am Continental Breakfast
7:00 am–6:00 pm Registration, Speaker Ready Room, Bookstore and RAPS Information Station Open
8:30 am–5:00 pm Preconference Workshops
10:30–11:00 am Refreshment Break

13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009

12:30–6:00 pm Career Center Open
12:30–1:30 pm Lunch
3:00–3:30 pm Refreshment Break

MONDAY, 14 SEPTEMBER
7:00–8:30 am
7:00 am–5:00 pm
Continental Breakfast
Registration, Speaker Ready Room, Bookstore, Career Center and RAPS Information Station Open
Conference Highlights
8:30–10:00 am Keynote Address & Fellows Induction Annual Celebration Reception
10:00 am–6:00 pm Exhibit Hall Open Get the evening started right! Join your colleagues
10:00–11:00 am Refreshment Break for a night of fun and celebration at RAPS’ largest
11:00 am–12:00 pm Concurrent Educational Sessions social gathering of regulatory professionals.
12:00–1:30 pm Lunch
12:00–1:30 pm Prepare for the RAC Exam
Awards Presentation and Closing Luncheon
12:30–1:15 pm Situation Rooms
Recognize the hard work, dedication, leadership
1:30–3:00 pm Concurrent Educational Sessions
and accomplishments of your colleagues
3:00–3:30 pm Refreshment Break as they are honored for their outstanding
3:30–5:00 pm Concurrent Educational Sessions contributions to the regulatory profession.
5:00–6:00 pm Exhibitors’ Reception
6:30 pm Dine-Arounds
Dine-Arounds
And you thought it was all cheesesteaks
TUESDAY, 15 SEPTEMBER
and pretzels! Many of the best and most
6:15–7:00 am RAPS Foundation 5K Fun-Run
innovative restaurants in the US can be found in
7:30–8:30 am Continental Breakfast
Philadelphia, and within steps of the Pennsylvania
7:30 am–5:00 pm Registration, Speaker Ready Room, Bookstore, Career Center and RAPS Information Station Open Convention Center. Join your colleagues for
8:30–10:00 am Concurrent Educational Sessions spirited conversation over great food and drink.
10:00 am–3:30 pm Exhibit Hall Open
10:00–10:30 am Refreshment Break
10:30 am–12:00 pm Concurrent Educational Sessions
Exhibitors’ Reception
Join your fellow conference attendees and
12:00–1:30 pm Lunch
exhibitors for friendly conversation, food and
12:30­–1:15 pm Situation Rooms
drink at this special networking reception––
1:30–3:00 pm Concurrent Educational Sessions
the first big social event of the conference!
3:00–3:30 pm Refreshment Break
3:30–5:00 pm Concurrent Educational Sessions
6:00–8:00 pm RAPS Annual Celebration Reception RAPS Fellows
Engage RAPS Fellows in thought-provoking
WEDNESDAY, 16 SEPTEMBER conversations in the new Situation Rooms and
throughout the conference. Watch the 2009
7:30–8:30 am Continental Breakfast
Class be inducted as new Fellows are recognized
7:30 am–12:00 pm Registration, Speaker Ready Room, Bookstore and RAPS Information Station Open
for their contributions to the profession.
8:30–10:00 am Concurrent Educational Sessions
10:00–10:30 am Refreshment Break
10:30 am–12:00 pm Concurrent Educational Sessions NEW! Situation Rooms
12:00–2:00 pm Closing Luncheon, Keynote Address and Awards Presentation Participate in provocative situation rooms
facilitated by RAPS Fellows that delve
interactively into today’s hottest topics.
3
4
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
:: Preconference Workshops
Register early for one of RAPS’ popular preconference workshops!
Increase your competitive advantage, improve your marketability and
advance your career. If you are new to the regulatory profession, changing
product lines/industry or preparing to take the RAC exam, these programs
will be of great benefit to you. Taught by highly-regarded regulatory
professionals, these workshops cover the latest information in a forum
involving open dialogue between participants and instructors. Join us for a
stimulating learning experience.
THE REGULATORY ESSENTIALS SERIES
These one-day programs offer concise, comprehensive, invaluable
overviews of the essentials of regulatory knowledge for the
pharmaceutical, biologics and medical device industries in various regions
around the globe.
Regulatory Essentials: Canada
• Canada’s Regulatory Environment
• The Impact of Regulatory Changes
• Premarket Requirements and Submissions: Devices, Drugs, Biologics,
Combination Products and Natural Health Products
• Clinical Trials (All Product Lines)
• Postmarket Requirements and Reporting (All Product Lines)
• Environmental and Provincial Regulations
• Advertising, Promotion and Labeling
Regulatory Essentials: EU
• Overview of EU Medicinal Products and Medical Devices Legislation
• Medicinal Products: Clinical Trials
• Medicinal Products: Marketing Applications
• Medicinal Products: Postmarketing Requirements
• Medical Devices: Classification
• Medical Devices: Conformity Assessment
• Medical Devices: Technical Documentation
• Medical Devices: Postmarketing Activities
• Combination Products
Regulatory Essentials: Japan
• Overview of Japan’s Healthcare Environment
• Japan’s Government Agencies
• The Basics and Overview of Regulatory Submissions
• Regulatory Submission Observations From the Reviewer’s Perspective
and Commonly Cited Deficiencies
• Undertaking Topicals: Quality, Third Party Review and Clinical Studies
• Perspectives on Pharmaceutical and Biologics Requirements
Register early for one of these popular preconference
workshops. These programs sell out!
RAPS.org/ac2009
13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009
Regulatory Essentials: US
• B rief History of Medical Product Regulation
• F DA Organizational Review
• O verview of Drugs and Biologics
• O verview of Medical Devices
• A dvertising, Labeling and Promotion for Drugs, Biologics and Devices
• P ostmarketing Requirements for Drugs, Biologics and Devices
• C ompliance and Enforcement
EFFECTIVE MEDICAL WRITING
Medical writing plays a crucial role in speeding product submission and
supporting compliance and the bulk of it is regulatory. Regulatory writing
is an integral part of the product development and approval process.
It includes protocols, clinical study reports, investigator’s brochures,
investigational and product applications, FDA briefing documents,
integrated summaries of efficacy and safety, manuscripts, abstracts,
posters, meeting coverage and product labeling. In this preconference
workshop, participants learn effective medical writing, Dos and Don’ts, Read why last year’s attendees think
and the differences between poor and high-quality writing. Specific issues
that the RAPS Annual Conference is a
include:
• G  ood Writing Practice must-attend event:
• W  riting High Quality Medicinal Product and Medical Device Study
Reports
“Great conference; I really enjoyed the
• E  ffective Management and Quality Control of Medical Writing Tasks preconference workshop (really useful!)…Bravo!
• M  edical Writer’s Role in Marketing Application Submissions I will surely come back next year!”
“Excellent programs and presenters.
NEW! ADVERTISING, PROMOTION AND LABELING Very knowledgeable.”
The regulatory environment for the advertising and promotion of healthcare
products continues to evolve with FDA, OIG and industry initiatives. “Wonderful avenue to network and gain
knowledge of the profession.”
In this unique program designed for mid-level professionals, RAPS will
bring together leading experts from industry, government and the legal
“One of the best conventions I have attended in
profession to share vital information on the latest regulations, guidelines, terms of presentations.”
enforcement actions and trends that may impact the advertising,
promotion and labeling of medical devices and pharmaceuticals.
“The RAPS event is very helpful in providing high-
level information and networking with colleagues
from the same areas of interest.”
“The event was very well done.”
5
 :: Session Descriptions
:: BIOLOGICS/BIOTECHNOLOGY
MONDAY, 14 SEPTEMBER
Gene Therapy: History and Current Status
11:00 am–12:00 pm | Professional Levels: I, II
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
While curing diseases caused by genetic defects by introducing genetic
material into individual cells may offer a significant medical benefit, gene
therapy also has the potential to cause serious harm or even death. As
a result, nearly 20 years after the first demonstration in humans, a gene-
therapy-based product still lacks approval. Senior regulatory manager
Cindy Fisher, PhD, will lead the discussion on recent developments from
the Center for Biologics Evaluation and Research’s Office of Cellular,
Tissue and Gene Therapy, to provide you with an understanding of what it
takes to conduct clinical research and to develop a gene therapy product
in today’s highly controlled regulatory environment.
Regulatory Models for Biosimilars
1:30–3:00 pm | Professional Levels: II, III, IV
In this session, legal expert Michael A. Swit, Esq., will brief participants
on the progress of pending bills in Congress that may provide a statutory
path for biosimilars as the 1984 Hatch-Waxman Act did for drugs. The
European regulatory system’s approach to generic biologics will also be
reviewed; and comparability and techniques for proving bioequivalence
with products that appear similar, but present significant variations in
immunogenicity will be discussed. You will be able to give your company
a better understanding of how the new model for generic biologics may
differ from the small molecule model, and how that will create a different
market for these products.
Visit RAPS.org/ac2009 for the latest and
most complete conference information.
Moving Stem Cell Products Into the Clinic
3:30–5:00 pm | Professional Levels: II, III
With much of the stem cell focus on research and development, not on the
regulatory questions, many products are in the IND stage of development with
no proven regulatory pathway for approval. Led by Debora Lavoie, JD, RAC,
this session will explore how regulatory agencies and industry are developing
regulations for cell and stem cell product development, preclinical and
clinical trial design, to enable future product approvals for needed medical
interventions.
6
TUESDAY, 15 SEPTEMBER
CBER Executive Staff Briefing
8:30–10:00 am | Professional Levels: I, II, III, IV
Global regulatory affairs expert Douglas Hunt will lead FDA’s Center for
Biologic Evaluation and Research (CBER) staff in a discussion about and
an update on recent activities and trends, as well as upcoming initiatives
and current developments. You will take home critical information
impacting your organization.
Submitting a BLA
10:30 am–12:00 pm | Professional Levels: II, III
Many start-up companies have little or no experience in submitting Biologic
License Applications (BLAs). FDA regulatory expert and consultant
Joyce Frey-Vasconcells and other experienced professionals will discuss the FDA
process and offer insights into regulatory strategies and timelines to help you
meet all requirements for successful, approvable and timely BLA submissions.
Counter-Bioterrorism Agents and the Animal Rule
1:30–3:00 pm | Professional Levels: II, III
In this session, William Egan, PhD, and speakers from both government
and industry will address legal and regulatory issues regarding biologics/
vaccines and the basics of FDA’s “Animal Rule”—what it can and cannot
do and how it is being implemented in the development of counter-
bioterrorism biological agents.
Biopharmaceutical Preclinical Safety Evaluation: The Case-by-Case Approach
3:30–5:00 pm | Professional Levels: II, III
To safely introduce novel therapies into clinical trials, preclinical safety
evaluation programs for biopharmaceuticals are customized based upon
specific product attributes (i.e., the case-by-case approach) and enhanced
utilizing experience with similar products. In this session, toxicology expert
Joy Cavagnaro, PhD, RAC, will lead current and former FDA regulatory
scientists in a discussion of key considerations for the successful
implementation of the “case-by-case” approach and how to better predict
whether programs will be acceptable to regulators. Presentations will address
recombinant proteins, monoclonal antibodies, and cell and gene therapies.
WEDNESDAY, 16 SEPTEMBER
Defining Homologous Use
8:30–10:00 am | Professional Levels: II, III
Many companies think they have a tissue product that is for homologous
use and are surprised when they receive notification from FDA indicating
otherwise. You will learn how to interpret and apply the criteria for HCT/P
tissue regulation, as well as other information needed for FDA submission,
in this session led by regulatory and tissue expert Joyce Frey-Vasconcells.
13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009
7
Grow your network
 :: BUSINESS
MONDAY, 14 SEPTEMBER
How Marketing and Regulatory Can Work Together
11:00 am–12:00 pm | Professional Levels: II, III
Establishing a strong relationship and open communications between
regulatory and marketing brings positive business results for healthcare
product manufacturers. Led by marketing expert Eric Langer, this
session will provide an overview of marketing’s responsibilities and goals.
Discussions will center on reconciling organizational goals between
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
regulatory and marketing and provide an understanding of what marketers
do and how they think.
Attend one (or more!) of these new Business Track sessions
and gain a critical understanding of
essential business basics.
Finance and Accounting in the Strategic Planning Process
1:30–3:00 pm | Professional Levels: II, III
More than support functions, finance and accounting are key components
of an organization’s success sometimes lightly regarded by regulatory
professionals involved in the product lifecycle, corporate strategy and
employee development. This session will address budgets, capital and
cash flow information, elements of investments and return on investment
(ROI) valuation information to help you increase your business acumen
and leverage your voice in the strategic planning process within your
organization.
Technical Fundamentals of R&D and Portfolio Management
3:30–5:00 pm | Professional Levels: II, III
Led by medical technology product expert Scott Bruder, MD, PhD, this
session will expand your knowledge of Research and Development
elements, such as establishing the unmet need and concept development;
product specification and design/target evaluation and selection; in
vivo and in vitro evaluation; and manufacturability and formulation
considerations for drugs, devices and biologics. This session will also
cover innovative clinical development strategies; strategic product
mapping; and stage-gate sequencing for the product pipeline and portfolio
management.
8
TUESDAY, 15 SEPTEMBER
Developing Successful Public Communications Strategies
8:30–10:00 am | Professional Levels: II, III
Public relations expert Peter Carson will lead this session on how
to create effective press releases that integrate a product’s clinical
development plan and enhance the value of the company’s public
communications program. Tips for addressing public inquiries arising from
investor conferences, clinical data releases, and postmarketing safety
issues and principles for how to determine the material nature of sensitive
information you are exposed to within a company will be introduced.
Operations and Manufacturing Processes Demystified
1:30–3:00 pm | Professional Levels: II, III
For top to bottom-line efficiency, it is important to understand how the
intricacies of your company’s operations and manufacturing tenets impact
the internal decision-making process. In this session led by
Sujal Bhalakia, you will take away valuable insight on supply chain
management, line flow, first pass yield, throughput, line balance and other
operations and manufacturing fundamentals. 
Government Affairs and the Regulatory Professional
3:30–5:00 pm | Professional Levels: II, III
Led by legislative expert Paul Barry, this session will greatly enhance your
ability to contribute to your company’s implementation of new policies and
regulations. The role of government affairs in evolving regulations and
business practices, individual company/trade group lobbying at the state
and federal levels and forecasting/tracking of potential legislative actions
will be addressed.
Take home key test-taking tips for the RAC examination!
Stop by during lunch and join an informal question and
answer discussion with RAPS staff and members with the
RAC designation in this new RAC preparation session.
Taking the RAC
Monday, 14 September
12:00–1:30 pm
 :: CLINICAL
MONDAY, 14 SEPTEMBER
New Pregnancy and Lactation Labeling Rule Revisions
11:00 am–12:00 pm | Professional Levels: I, II
In 2008, FDA proposed major revisions to prescription drug labeling,
requiring that detailed information be provided about the use of drugs/
biologics by women who are pregnant, nursing or of childbearing age.
Led by regulatory expert Lisa Jenkins, PhD, this session will give you an
overview of the proposed rule and provide current information on design of
lactation studies.
CASE STUDY: Adaptive Clinical Trial Designs That Get Results
1:30–3:00 pm | Professional Levels: III, IV
The proper use of adaptive clinical trial design can lead to more
efficient data collection, a higher probability of success and quicker
drug development. Led by regulatory expert Lisa Jenkins, PhD, this
session will review changes to regulations and guidances impacting
the use of adaptive clinical trials and present you with perspectives
from regulatory agencies (Health Canada and FDA) on the various
design methodologies. You also will learn about recent developments
in the Canadian Progressive Licensing Project that bear on the use of
adaptive trial designs during early and late stage development.
Clinical Trial Requirements: Similarities and Differences (US, EU and
Japan)
1:30–3:00 pm | Professional Levels: II, III
Globalization of marketing applications affects the preclinical, clinical
and postmarketing phases of the healthcare product lifecycle. In this
session led by compliance expert Anita Fenty, MS, RAC, you will review
the similarities and differences in clinical trial and adverse event reporting
requirements among the US, EU Member States and Japan. How to best
apply this information throughout the preclinical through marketing phases
will also be covered.
FDA Requirements for Using ClinicalTrials.gov
3:30–5:00 pm | Professional Levels: I, II, III, IV
Clinical studies are a critical component of getting your product approved
and onto the market. Requirements for clinical trial registration and study
publication have changed significantly, and failure to register your trial
could mean results will never get published. Your company could get fined
up to $10,000 per day if you don’t disclose the study results within a year,
regardless of the status of your FDA submission. Led by clinical studies
specialist Karen Bannick McQuoid, MA, this session will update you on
new and evolving FDA requirements and show you how to get trial results
published and available to the scientific community.
TUESDAY, 15 SEPTEMBER
Designing Clinical Trials With the Target Product Profile in Mind
10:30 am–12:00 pm | Professional Levels: II, III
Placing an emphasis on the final product label early in development can
produce significant benefits as you approach commercialization. In this
session led by regulatory expert John Wood, you will learn how to establish
a labeling strategy and leverage tools like FDA’s Target Product Profile to
streamline development and ensure important commercial messages are
built into the overall process.
13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009
Top 10 Mistakes Sponsors Make in Clinical Trials
1:30–3:00 pm | Professional Level: II
Led by clinical study consultant Jillian Reed, this session will make you
aware of the top 10 pitfalls medical device sponsors commonly encounter
during clinical trials, such as investigational site selection, monitoring
nightmares and missed enrollment deadlines. This information will help
you assess both current and future clinical trials with an increased
knowledge of how to complete your study successfully and get your
product to market with minimal mistakes along the way.
Ethical Standards in Clinical Research
3:30–5:00 pm | Professional Levels: I, II
Many experts believe individual institutions and associations should
adopt stricter standards of conduct in clinical research than those
reflected in current federal regulations, which do not hold investigators
or institutions responsible for supervising and training clinical trial staff.
Led by development program expert William Sietsema, PhD, this session
will show you how to recognize and address fraud and misconduct—from
improper patient protection and falsification of data to sponsor payments
to investigators for nonclinical study-related expenses and disclosure
obligations under 21 CFR Part 54.
Don’t miss the new Situation Rooms.
These interactive sessions provide dynamic learning
on current hot topics facing the regulatory profession
in a town hall style format!
RAPS.org/ac2009
9
10
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape

Advance
your career

WEDNESDAY, 16 SEPTEMBER
Using Postmarket Surveillance Data for Medical Devices
8:30–10:00 am | Professional Levels: II, III
For medical device companies, it is challenging to assess the safety of
devices with only clinical trial data. This session will make you aware
of special safety review considerations for clinical trials in light of risk
management requirements established by ISO 14971, and strategies for
integrating postmarket surveillance elements.
Preparing for FDA Audits of Clinical Studies
10:30 am–12:00 pm | Professional Levels: I, II
Many procedures need to be developed and implemented to prepare a
site for an FDA bioresearch monitoring (BIMO) inspection, which focuses
on specific areas such as risk management processes. In this session
led by quality assurance and control expert Gloria Miller, RAC, you will
get an overview of FDA’s BIMO program, including what to expect from an
inspection, how to develop procedures to ensure your site is ready and
what needs to be done after the fact.
RAC AND
CONTINUING EDUCATION CREDITS
Full conference attendees will receive 12 RAC recertification credits
for conference attendance and 6 credits for preconference workshop
attendance. In addition, many Annual Conference sessions are eligible
for pharmacy continuing education credit. Visit RAPS.org/ac2009 for
more information. Extension Services in Pharmacy at the University
of Wisconsin–Madison School of Pharmacy is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Statement of credit for continuing pharmaceutical
education participation will be mailed within six weeks of receipt of
completed evaluations.
:: COMBINATION PRODUCTS
MONDAY, 14 SEPTEMBER
Tissue Engineered Combination Products—Coordination Is Key
11:00 am–12:00 pm | Professional Level: II
Tissue engineered products often consist of a biologic and a device,
each of which can potentially be produced by a different company. Led by
tissue expert, Joyce Frey-Vasconcells, this session will present a detailed
analysis of the complexity and critical components of developing a tissue
13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009
engineered product and the regulatory considerations involved. The
interaction and coordination between different organizations within and
outside your company that may come into play will be discussed.
Cross Labeling–Fact or Fiction?
1:30–3:00 pm | Professional Levels: II, III
In 2005, the Office of Combination Products (OCP) held a conference on the
cross labeling “problem.” In 2008, OCP issued guidance on New Contrast
Imaging Indications. Led by regulatory specialist Suzanne O’Shea, JD, this
session will examine whether cross labeling really poses a significant problem
and what OCP’s guidance suggests about the future of cross labeling. You will
learn how separately marketed products might be considered combination
products through labeling, when cross labeling is and isn’t required, some
creative possibilities and whether it can ever work to your advantage.
Postapproval Changes for Combination Products
3:30–5:00 pm | Professional Levels: I, II, III, IV
New technologies and advances in medical practice have served as
catalysts for the introduction of combination products that offer safer,
more effective and convenient treatments for patients. In this session
led by regulatory specialist Raymond Seda, MBA, RAC, you will gain an
understanding of FDA’s Office Combination Product (OCP) perspective and
future initiatives and its role on guidance of and interaction with the lead
centers (CDRH, CDER, CBER). Applicable postapproval requirements and
practical examples of postapproval changes for combination products
regulated as devices, drugs and biologics will be covered.
CASE STUDY: Navigating the Scientific and Regulatory Dividing Line
Between Drugs and Devices
3:30–5:00 pm | Professional Levels: II, III
Led by combination product consultant and expert Miriam Provost, PhD,
this session will review the regulatory definitions for drugs and devices
and provide insight into how these definitions may overlap. The legal,
regulatory and scientific bases for jurisdictional determinations regarding
chemical mode of action and how to resolve issues will be discussed
through examples and case studies.
11
 TUESDAY, 15 SEPTEMBER
CASE STUDY: Combination Product Regulation in Asia
8:30–10:00 am | Professional Levels: II, III
Global regulatory expert Nigel Hernandez, PhD, RAC, will lead
this session addressing current and future regulatory initiatives,
legislation and requirements for combination products in China and
Japan, including the framework and bodies (e.g., China’s SFDA re-
registration requirements and type testing requirements and Japan’s
PMDA and MHLW), the consultation process and relevant draft
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
regulations. Case studies and important elements for combination
products will be discussed, as will ASEAN and the common
submission dossier template.
Shedding Light on New Rules for Adverse Event Reporting
10:30 am–12:00 pm | Professional Levels: I, II, III, IV
In recent years, the combination products industry has grappled with
how to address conflicting rules for reporting adverse events. FDA has
published a concept paper on a proposed rule. Led by regulatory law
expert Bradley Thompson, MBA, JD, RAC, this session will teach you how
to apply current requirements to your company’s products and operations
at both a strategic and tactical level. Industry reactions to the proposed
rule, implications for drug and medical device companies that market
combination products and case studies relevant to implementation will be
discussed.
OCP Executive Staff Briefing
1:30–3:00 pm | Professional Levels: I, II, III, IV
Most experts predict that combination products will continue to be a
significant growth area for the healthcare industry. Industry expert and
former OCP Director Mark Kramer, RAC, will moderate this session
featuring leadership from FDA’s Office of Combination Products (OCP)
discussing priorities and current policy initiatives, key regulations and
guidance documents. You will benefit from the insight and perspectives of
the Combination Products Coalition, a leading advocacy group for policy on
regulatory issues affecting combination products.
RAPS Foundation 5K Fun-Run
Climb the famous “Rocky Steps” at the Philadelphia
Museum of Art, and see a bit of Philadelphia in this brief jog
around Philadelphia’s historic neighborhoods.
(Separate on-site registration required).
12
WEDNESDAY, 16 SEPTEMBER
CASE STUDY: FDA’s New Approach to Good Manufacturing Practice
Requirements
8:30–10:00 am | Professional Levels: I, II, III
Currently, there are no regulations describing or prescribing Good
Manufacturing Practices for combination products, and there is
recognition within FDA, industry and the legal community that further
regulatory and inspectional clarity and guidance are needed. Led by
regulatory law expert James Cohen, Esq., this session will provide you
with an overview of FDA’s proposed rule on CGMPs for combination
products, the legal basis and rationale, the implications for device
and drug companies, case studies on how to meet the requirements,
alternatives to the proposed rule and views on whether FDA’s
approach is the appropriate one for the agency and industry.
Traversing the Canadian Regulatory Landscape
8:30–10:00 am | Professional Levels: I, II, III
You will learn the route your combination product must take in the
Canadian approval process and hear information on Canada’s current
regulatory environment for combination products in contrast with other
jurisdictions in this session led by Canadian regulatory expert
Mary Speagle, RAC. Discussions will include the role of the Therapeutic
Products Classification Committee and application techniques for various
policy and illustrative case studies will be presented along with upcoming
initiatives under the Blueprint for Renewal.
Impact of EU Rules Governing Devices on Combination Products
10:30 am–12:00 pm | Professional Levels: II, III, IV
EU regulatory expert Elisabethann Wright, will lead this session
addressing current and future initiatives, legislation and regulatory
requirements for combination products. European Commission proposals
to modify current EU medical devices legislation and stakeholders’
opinions on those proposed changes will be examined. Implications of the
revision to the Medical Devices Directive that will enter into force in 2010
and other expected regulatory changes in coming years, for both medical
devices currently in development and pipeline products, will be examined.
 :: COMPLIANCE AND AUDITS
MONDAY, 14 SEPTEMBER
Good Clinical Practice Compliance in Clinical Trials
11:00 am–12:00 pm | Professional Levels: I, II
Individuals from pharmaceutical companies, contract research organizations
(CROs) and academic institutions involved with the supervision or oversight
of clinical trials will learn the principles and requirements for Good Clinical
Practices (GCPs) in this session led by compliance expert Gloria Miller, RAC.
Key Points for GMP-Production Compliance
3:30–5:00 pm | Professional Level: II
Understanding the key requirements of Good Manufacturing Practice
(GMP)-production compliance is essential for regulated industry. Led by
compliance expert Robert Schiff, PhD, RAC, this session will cover the
GMP regulations, documentation requirements, corrective and preventive
action (CAPA) plans, self-examination and internal auditing. Compliance
from the receiving area to the warehouse, staging, manufacturing,
packaging, shipping and quality control, and areas of FDA inspection focus
will be discussed.

13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009

FDA and ICH requirements for sponsors, monitors and investigators will be
covered and techniques for evaluating compliance levels at clinical sites and
how to implement corrective/preventative actions to ensure optimum GCP
WEDNESDAY, 16 SEPTEMBER
compliance will be introduced.
Validation Compliance: What’s Required?
8:30–10:00 am | Professional Level: II
Drug/Biologic Preapproval Inspection (PAI)—A Survival Guide Having a firm understanding of what areas require validation and
1:30–3:00 pm | Professional Level: II qualification to meet FDA expectations is critical to the regulatory
process. This session will provide an overview of method validation for
All pharmaceutical and medical device manufacturers are encouraged to be
quality control, purified water and transfer validation. Key expectations
prepared for FDA inspections regardless of whether a pre-announcement
of regulators on validation and the differences between qualification and
has been received. In this session led by senior regulatory consultant
validation will be summarized and demonstrated.
Harindranath Nagaradona, PhD, you will examine the steps that a company
would implement to prepare for and ensure a successful preapproval
inspection (PAI), including developing corporate SOPs to consistently
Successfully Completing Failure Investigations and OOS
manage inspections at all applicable sites, properly training personnel at all
10:30 am–12:00 pm | Professional Level: II
levels, and interacting with FDA investigators in a positive manner.
Led by compliance training specialist Hal Dayton Hopkins, this session
will give you an outline of the process for robust failure investigations
and out-of-specification (OOS) investigations for regulated industry.
TUESDAY, 15 SEPTEMBER The key elements in completing and documenting investigations to
achieve regulatory expectations will be discussed, and best practices
How to Respond to a Warning Letter
for determining root cause and ensuring closed loop systems for
8:30–10:00 am | Professional Levels: III, IV
investigations will be reviewed.
This session, led by regulatory consultant Susan Jacobs, will review
elements of regulatory inspection responses and outline key areas of
evaluation you should consider before replying to an inspection or Warning
Letter, including corrective and preventive action target completions. How
to respond to FDA Form 483, what information and the level of detail to
include, appropriate timeframes, and who should interact with the FDA
district office will be discussed. Visit the Career Center
Confidentially browse open regulatory positions,
Addressing Good Laboratory Practice (GLP) Testing Concerns pick up career related literature from leading employers
1:30–3:00 pm | Professional Levels: II, III and use the drop box to submit your resume.
Drug, device and/or chemical submissions all require GLP processes. RAPS.org/ac2009
If these initial data are not verified, robust and well documented, all
subsequent information may be inadmissible. Led by GLP specialist Amy
Wright, PhD, RAC, this session will introduce you to areas of concern with
GLP testing in the early stages of new product development, including
potential GLP preclinical testing issues involving an “in house” lab or
contract research organization, and how the regulatory professional can be
more aware of QA needs.

13

:: MEDICAL DEVICES AND IVDS
MONDAY, 14 SEPTEMBER
The Future of GHTF?
11:00 am–12:00 pm | Professional Levels: I, II, III, IV
The Global Harmonization Task Force (GHTF) was established in 1992
in an effort to achieve greater uniformity among national medical device
regulatory systems. In this session led by international regulatory specialist
Rainer Voelksen, you will hear from GHTF representatives on the impact
and benefits of current initiatives for the medical device industry. The
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
recently developed guidance on supplier quality and a new guidance on
CAPA, as well as information on new countries using or considering GHTF-
type systems when introducing a new regulatory framework, will be covered.
Registration is easy!
Visit RAPS.org/ac2009 for more information
on how to register online, by fax or phone.
Common Pitfalls and Best Practices in CLSI Study Design
11:00 am–12:00 pm | Professional Levels: I, II, III, IV
Understanding the analytical and clinical study requirements to support a
successful IVD submission is key to getting your new product approved.
In this session led by regulatory expert Juliet Carrara, RAC, you will learn
about the applicable regulations, guidance and standards and increase
your ability to provide appropriate guidance to enhance your credibility
within your organization and with reviewers. Discussions will address how
to identify applicable standards; when to do analytical (bench) testing
versus clinical studies; and examples of successful and failed proposals
for alternatives to Clinical and Laboratory Standards Institute study design.
CDRH Executive Staff Briefing
1:30–3:00 pm | Professional Levels: I, II, III, IV
In this session led by policy expert Mark Gordon, MS, RAC, you will
hear a detailed review of the past year at FDA’s Center for Devices
and Radiological Health (CDRH) as well as an overview of initiatives,
milestones and current trends for the next year. You will hear directly from
senior-level CDRH and industry professionals and you’ll take home critical
information impacting your organization.
A Deeper Understanding of Companion Diagnostics
3:30–5:00 pm | Professional Levels: I, II, III, IV
You will discuss personalized medicine, types of companion diagnostics,
labeling considerations and case studies on development and regulatory
strategy in this session led by senior regulatory expert James Kelly, PhD.
Agency and industry perspectives will be included in the discussion.
14
PMDA Update: Future Initiatives and Challenges
3:30–5:00 pm | Professional Levels: II, III
In this session, led by Japanese regulatory expert Kyoichi Tadano, PhD, hear
directly from senior officials of Japan’s Pharmaceuticals and Medical Devices
Agency about PMDA’s Fiscal 2009–2013 second midterm action and policy
plan. Speakers will outline the second midterm plan and discuss future
agency directions, as well as PMDA’s current initiatives and challenges for
quicker medical device review and more effective lifecycle management.
A 2010 Approach to the Medical Devices Directive (MDD)
3:30–5:00 pm | Professional Levels: I, II, III, IV
Led by medical device expert Gary Barrett, this session will brief you
on various MDD updates that will enter into force in March 2010 and
provide you with an update on IVD regulations. MDD changes, including:
EU expectations and direct effects on manufacturers; changes in labeling
and instructions for use, single use, risk analysis, postmarket surveillance,
clinical and technical files/dossiers and the essential requirements; and
how these changes affect certification will be discussed.
TUESDAY, 15 SEPTEMBER
FDA Office of IVD Evaluation and Safety Special Topics
8:30–10:00 am | Professional Levels: I, II, III, IV
The transition of products from an unregulated environment to one with
regulations can provide many unique challenges including analyte specific
reagents (ASRs), laboratory developed tests (LDTs) and IVD Multivariate
Index Assays (IVDMIAs); closed and open laboratory instrumentation;
and de novo downclassification. This session led by Rose Romeo, PhD,
will provide examples of such transitions involving products that can now
be viewed as in vitro diagnostic medial devices. Case histories will be
presented for situational analysis of topics ranging from initial planning to
submission planning and overall compliance activities.
Emerging Markets: Regulatory Challenges and Considerations
8:30–10:00 am | Professional Levels: II, III
With the slow moving market in the West, more companies are looking to
emerging markets to expand sales. Regulations in emerging markets are
less mature and present many obstacles to Western businesses
hoping to gain entry. This session, led by medical device consultant
Chang-Hong Whitney, MBA, will focus on the regulations and regulatory
challenges in the emerging markets of China, Taiwan and South America.
The Pennsylvania Convention Center is centrally located
in downtown Philadelphia in close proximity
to the city’s fabulous restaurants and sights.
13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009
15
Impact the profession
 Japan in Focus: Regulations for Medical Devices
10:30 am–12:00 pm | Professional Levels: II, III
This session, led by Japanese regulatory expert Yuka Suzuki, PhD,
will provide you with information on current regulatory processes and
basic requirements for medical device registration in Japan. In addition,
regulatory and industry representatives will discuss the current status and
challenges facing the cooperative Japanese-US effort, Harmonization by
Doing (HBD), and its impact on international regulatory harmonization for
medical devices.
Unique Device Identification—Requirements and Considerations
10:30 am–12:00 pm | Professional Levels: I, II, III, IV
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
The establishment and implementation of a Unique Device Identification
System (UDI) is required by the Food and Drug Administration Amendments
Act of 2007. Led by data standards expert Dennis Black, this session
will give you an understanding of the UDI Law and FDA’s perspective on
regulation, US market needs and mandates, ways UDI aligns with current
manufacturing processes and business practices, global UDI needs and
key implementation considerations. Efforts toward developing a global UDI
for medical devices will be addressed.
CASE STUDY: Identifying Premarket Medical Device Issues
1:30–3:00 pm | Professional Levels: II, III
In this session led by quality and regulatory affairs expert Joel Kent,
RAC, you will be given a background on the subjects of FDA pre-IDE
(investigational device exemption) processes for medical devices
and Canadian medical device submissions. You will participate in
small groups to review various case studies presented and propose
workable solutions.
Improving Postmarket Device Surveillance with Healthcare Professionals
1:30–3:00 pm | Professional Levels: II, III
This session will include a discussion of the review of surveillance areas
such as significant adverse events and medical device reporting and their
links to management review, complaint boards and recalls, as well as the
need to communicate this expertise to healthcare professionals.
A Closer Look at Standards for Medical Devices
3:30–5:00 pm | Professional Levels: II, III
This session will address the increasing role that standards (design,
testing, labeling) are playing as de facto requirements for global premarket
submissions, and why regulatory professionals need to understand more
about this increasingly critical area. The discussion will include a look
at how emerging developments and trends are shaping medical device
regulation.
16
CASE STUDY: Noncompliance Risks in Labeling, Advertising and
Promotion
3:30–5:00 pm | Professional Levels: I, II
To educate the medical device developers and users about the
standards against which the devices will be evaluated and potential
risks of noncompliance with labeling, advertising and promotional
material review processes, regulatory reviewers should be well-versed
on logistics and well-informed about the timing, audience and delivery
mode of the devices. Led by senior regulatory specialist Virginia
Garcia, RAC, this session will provide you with a valuable overview
and demonstrate specific examples of how to communicate with key
stakeholders to improve the efficiency of the review process.
WEDNESDAY, 16 SEPTEMBER
CLIA: Ensuring Quality Laboratory Testing
8:30–10:00 am | Professional Levels: I, II, III, IV
This session, led by Brooke Bumpers will review the Clinical Laboratory
Improvement Amendments (CLIA) of 1988, CLIA regulations for
laboratories, FDA CLIA Complexity Categorization Process and CLIA Waiver
Applications for in vitro diagnostics. Reimbursement considerations and
processes will be discussed. You will take away strategies that can be
implemented within your organization to improve business.
Practical Tips for Implementing Quality Systems
10:30 am–12:00 pm | Professional Levels: I, II
The time and cost to implement and maintain a quality system are a big
investment and can be burdensome for small companies. In this session led
by medical laboratory technology specialist Nancy Ruth, RAC, you will learn
how to ensure the quality system is designed to meet requirements for your
company’s target markets, including documentation and implementation
strategies, selection of certification bodies, auditor interface, avoiding gaps
in the audit process and getting the most value for your investment. ISO
13485:2003 for Canada, the EU and the US FDA Quality System Regulation
will be covered.
Have Your RAC?
Earn up to 12 recertification credits by
attending this year’s Annual Conference.
 :: PHARMACEUTICALS
MONDAY, 14 SEPTEMBER
Pros and Cons of Alternative Models in Preclinical Studies
11:00 am–12:00 pm | Professional Levels: III, IV
Alternatives to whole-animal testing include endpoint assays, cell and
tissue cultures, the use of tissue slices, toxicokinetic modeling and
structure-activity relationships and databases. Concordance between
results from alternative tests and those from animals is an important
TUESDAY, 15 SEPTEMBER
Recent Advances in Oncology Drug Development
8:30–10:00 am | Professional Levels: II, III
New drug and therapeutic biologic cancer treatments and new uses for
existing treatments are developed every year. Regulatory agencies must
balance the need to ensure the safety and efficacy of these promising
medicines against making them available to the public in a timely manner.
In this session led by global regulatory expert Daniel Mannix, PhD, you
will examine the role of regulatory agencies in facilitating the review and

13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009

action on promising new cancer therapies, and gain insight into the use of
issue in protecting public safety. Led by preclinical research specialist
different endpoints to support such approvals.
Alan Stricker-Krongard, PhD, this session will review alternatives and the
steps being taken to ensure these methods can be just as predictive as
animal models, as well as the regulatory implications of using alternative
Asia Regulatory Update
tests.
10:30 am–12:00 pm | Professional Level: II
Over the last decade, Asia has seen continued positive growth, making it a
Quality by Design (QbD): A Framework for Success strategic region for development and marketing of medicinal products. Led
11:00 am–12:00 pm | Professional Levels: II, III by global regulatory expert Munish Mehra, PhD, this session will highlight
national and regional requirements for obtaining permission to conduct
ICH Guidelines Q8, Q9 and Q10 have provided an avenue for flexible
clinical trials, Good Clinical Practices and filing for approval to place
regulatory approaches to the filing of chemistry, manufacturing and
medicinal products on the market. You will discover current development
controls (CMC) information, in both the initial marketing application and
strategies for China, India and Japan in order to understand the regulatory
subsequent postapproval submissions. The first of the guidelines took
environment, challenges and opportunities in Asia.
effect in 2006 and several pharmaceutical manufacturers have utilized
them in preparing regulatory submissions. In this session led by
Gerry DiDonato, ScD, you will learn some of the regulatory challenges and
opportunities faced by industry to date.
Get the latest information and updates.
Visit RAPS.org/ac2009.
Latin America Regulatory Update
1:30–3:00 pm | Professional Levels: I, II, III
Latin America continues to be seen by the pharmaceutical industry as
an appealing emerging market, due in part to its interest in outsourcing EMEA Executive Staff Briefing
clinical trials, but also because of the potential for continued future market 10:30 am–12:00 pm | Professional Levels: I, II, III, IV
expansion. This session will give you insight into Latin America’s evolving
Outlined in 2005, the EMEA roadmap details the European Medicines
regulatory landscape and its agencies. Major processes and requirements
Agency’s five-year action plan and priority objectives. You will learn how
will be discussed so you can walk away with a better understanding of the
regulatory initiatives in the EU may impact your company or product in this
regulatory opportunities and common challenges in the region.
session moderated by international regulatory expert David Jefferys, MD.
EMEA representatives will discuss progress on these objectives and other
events of the past year, including recent activities of the Committee for
CDER Executive Staff Briefing
Medicinal Products for Human Use. Plans and projects being undertaken
3:30–5:00 pm | Professional Levels: I, II, III, IV
for the coming year will also be covered.
Wrought with accomplishment and challenge, 2009 was an eventful
year for FDA’s Center for Drug Evaluation and Research (CDER). A senior
representative will discuss the center’s initiatives and implementations
over the past year during this session, moderated by international
regulatory expert David Jefferys, MD. You will gain insight into CDER plans
and priorities for 2010 and hear directly from CDER on issues that may
significantly affect your company’s regulatory operations.

17
18
2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape

Ensure
the health of your career
REMS: A Real-World Implementation
10:30 am–12:00 pm | Professional Levels: II, III
The Food and Drug Administration Amendments Act of 2007 imposed
the requirement for postmarketing Risk Evaluation and Mitigation
Strategy (REMS) plans for certain products. This legally enforceable
obligation places greater burdens on pharmaceutical companies to
design and implement a REMS program that meets FDA standards. Led
by pharmacovigilance expert Rita Cassola, this session will review a
REMS plan from inception through final implementation for a currently
marketed product. You will learn some of the important considerations in
executing an efficient company team effort and gaining final acceptance
by FDA. There will be special focus on certain caveats that warrant special
attention in the REMS.
Improve Supply Chain Management
1:30–3:00 pm | Professional Levels: II, III, IV
In this session, you will learn ways to ensure the quality and integrity of
pharmaceutical ingredients with a focus on auditing suppliers. Supply
chain management techniques and trends will be introduced.
Health Canada Executive Staff Briefing
3:30–5:00 pm | Professional Levels: I, II, III, IV
Health Canada’s Blueprint for Renewal aims to modernize Canada’s
regulatory processes by transforming its legislative, regulatory and policy
frameworks. In this session led by Canadian regulatory expert Patricia
Anderson, RAC, you will hear from a senior representative regarding the
agency’s progress on this and other key initiatives as well as future plans.
You will gain an understanding of how these changes could impact the
requirements when operating within this well-established regulatory regime.
This year you’ll find more interactive sessions, more
global perspectives and interactive case study sessions
led by experienced regulatory professionals.
Global Pediatric Development Programs: Fantasy or Reality?
3:30–5:00 pm | Professional Levels: II, III
Although US and EU requirements for pediatric programs are well
established, industry is challenged to design programs that provide
important information about the use of drugs and biologics in children
while meeting the requirements of health authorities and not unduly
exposing vulnerable populations to risk. Leading pediatric drug strategist
Mary Christian, PharmD, will facilitate a panel discussion to review recent
examples of challenges to global programs and explore a path forward.
You will be able to provide sound strategic regulatory guidance within your
organization’s development programs.
WEDNESDAY, 16 SEPTEMBER
Risk/Benefit Presentations That Lead to Drug Approvals
8:30–10:00 am | Professional Levels: II, III
Regulatory agencies have expressed a need to improve methodology,
transparency, consistency and communication of risk/benefit information
for new drug (or indication) approvals. You will learn how safety and
efficacy information is provided in NDA submissions, and the difficulties
faced by reviewers of that data, in this session led by drug safety expert
Carrie Corboy, PharmD. Methodologies being developed to address these
13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009
difficulties and to standardize presentations in a semi-quantitative way will
be introduced.
Rx-to-OTC Switch
8:30–10:00 am | Professional Levels: II, III, IV
Regulatory hurdles for moving a product from prescription to over-
the-counter (OTC) status are stringent, but the switch can offer both
public health benefits and enhanced return on R&D investment for the
manufacturer. In this session led by global regulatory and compliance
expert Susan James, industry representatives will explore the unique
challenges of extending product lifecycle through an Rx-to-OTC switch, with
switch strategies focusing on decision makers, influences and processes.
505(b)(2) & Related Applications in the US, EU and Canada
10:30 am–12:00 pm | Professional Levels: II, III
Regulatory professionals are often challenged to find creative strategies
to get to market faster, obtain product exclusivity and limit the amount
of data required for submission. In this session led by drug and device
regulatory expert Susan Mondabaugh, PhD, you will learn about 505(b)(2)
NDA strategies in the US and similar applications in the EU and Canada,
including recent trends, challenges and the current regulatory and legal
environment. You will discover how these strategies may apply to your
company’s development programs.
Cardiac Safety From Preclinical to Postmarketing
10:30 am–12:00 pm | Professional Level: II
Cardiac safety is still the number one cause for approval process delay
or termination by regulatory authorities. It is also the leading cause of
market recalls. Led by risk management expert Bernhard Heiles, MD, PhD,
this session will teach you about potential cardiac effects, such as heart
muscle, electrical conduction or oxygen use, and ways to document and
interpret them in light of regulatory requirements for drug development and
lifecycle management. The importance of regulatory involvement in broad
cardiac safety and risk management efforts will be highlighted enabling
you to see the “big-picture” of cardiac safety throughout the lifecycle of
your product.
19

2009 RAPS Annual Conference & Exhibition :: Succeeding in the New Regulatory Landscape
Conference Registration
Registering for the conference is easy!
Simply visit RAPS.org/ac2009. Register by
20 August 2009 to save $150 off the RAPS
member rate.
Attending as a group? RAPS offers a
discount for three or more people attending
from the same company and registering at
the same time.
More ways to save! RAPS also offers
discounted rates for individuals who work for
a government or nonprofit organization and
full-time students.
Visit RAPS.org/ac2009
for more information.
20
:: Speakers
Erik Berglund, MD, PhD, RAC, associate managing
director CRSD, senior regulatory scientist II, Cato
Research
Paul Brooks, vice president and country manager, BSI
PS Healthcare
Arthur Caplan, PhD, professor, University of
Pennsylvania
Sandra Dennis, deputy general counsel, healthcare,
Biotechnology Industry Organization (BIO)
Robert Dormer, JD, director, Hyman, Phelps &
McNamara PC
Paul Falkenstein, MBA, PhD, vice president, product &
portfolio processes, Becton Dickinson
Tracey Fox, RAC, regulatory programs manager, GE
Healthcare
Axel Hoos, MD, PhD, medical lead, immunology and
oncology, Bristol-Myers Squibb International
Virginia Johnson, PhD, vice president, regulatory
affairs, Emergent BioSolutions Inc.
Kenneth Kostenbader, MD, head drug safety,
Americas, Actelion Pharmaceuticals
Raj Kishore, PhD, senior director, EMD
Pharmaceuticals
Areta Kupchyk, JD, Reed Smith LLP
Nicole Landreville, regulatory affairs leader, GE
HealthCare
Douglas Mead, director, global CMC regulatory affairs,
medical devices and combination products,
Johnson & Johnson Pharmaceutical Research &
Development LLC
Gillian Miller, PhD, RAC, consultant, SciLucent LLC
Rhonda Moe, RA/QA consultant, BioReg Technologies
LLC
Madoka Murakami, reviewer, Office of Medical
Devices, Pharmaceuticals and Medical Devices
Agency
Yuzuru Okazaki, PhD, reviewer, Office of Medical
Devices, Pharmaceuticals and Medical Devices
Agency
Barbara Redman, PhD, RN, dean and professor,
College of Nursing, Wayne State University
Rosina Robinson, RAC, principal consultant, Medical
Device Consultants Inc.
Howard Rosen, director, corporate sales, Boston
Scientific Inc.
Shiho Tanaka, senior manager, regulatory affairs,
Medtronic Japan Co. Ltd.
Mya Barbara Thomae, RAC, Regulatory Affairs
Consultant, Myraqa
Robert Timko, PhD, director, regulatory CMC group,
AstraZeneca LP
Satoshi Toyoshima, PhD, director, Center for Product
Evaluation, Pharmaceuticals and Medical Devices
Agency
Hiroshi Yaginuma, specialist for new materials, Office
of Medical Device Evaluation, Ministry of Health,
Labour and Welfare
Xin Min Yue, RAC, DVM, regulatory consultant, Eli Lilly
& Company
Brigitte Zirger, director, Bureau of Policy, Science and
International Programs, Health Canada
:: Session Leaders
Patricia Anderson, RAC, vice president, regulatory
services, Canreg Inc.
Karen Bannick McQuoid, principal and founder, Bannick
Consulting LLC
Gary Barrett, project manager, KEMA Quality BV*
Paul Barry, director, Boston Scientific
Eric Berg, director, supplier quality, Amgen Inc.*
Sujal Bhalakia, vice president, Becton Dickinson
Dennis Black, director, e-business, Becton Dickinson
Scott Bruder, MD, PhD, senior vice president and CTO,
Becton Dickinson
Brooke Bumpers, counsel, Hogan & Hartson*
Juliet Carrara, RAC, vice president, RA/QA, OptiScan
Biomedical Corp.*
Peter Carson, executive vice president, Powell Tate | Weber
Shandwick
Rita Cassola, associate director, pharmacovigilance,
Canreg Inc.
Joy Cavagnaro, PhD, RAC, president and founder, Access
BIO LLC*
Mary Christian, PharmD, director, co-chair Pediatric Drug
Development Committee, Bristol-Myers Squibb*
James Cohen, Esq., shareholder, Buchanan Ingersoll &
Rooney*
Julia Cooper, PhD, senior director, worldwide head of
medical writing services, Parexel International Ltd.*
Carrie Corboy, PharmD, senior director, translational
pharmacovigilance, Johnson & Johnson
Gerry DiDonato, ScD, associate director, Bristol-Myers Squibb*
William Egan III, executive vice president, global skin care,
Johnson & Johnson Consumer Products Co.*
Anita Fenty, RAC, manager, regulatory policy, Covance Inc.*
Cindy Fisher, PhD, senior manager, regulatory affairs, Vical
Incorporated
Joyce Frey-Vasconcells, executive director, cells, tissues
and gene therapy, PharmaNet Consulting*
Virginia Garcia, RAC, senior regulatory affairs associate,
Davol Inc.*
Mark Gordon, MS, RAC, vice president global regulatory
advocacy and policy, Boston Scientific Inc.
Laila Gurney, RAC, director, regulatory affairs, Canada, GE
Healthcare*
Bernhard Heiles, MD, PhD, senior director, global
pharmacovigilance & risk management, Shire
Pharmaceuticals
Nigel Hernandez, PhD, RAC, founder and president, Center
for the Study of Regulatory Affairs*
Hal Dayton Hopkins, associate director, quality control,
Abbott Laboratories
Doug Hunt, senior director, global regulatory affairs, Baxter
Healthcare
Susan Jacobs, president, principal consultant, QMS
Consulting Inc.
Susan James, vice president, worldwide regulatory affairs,
compliance and quality, GlaxoSmithKline Consumer
Healthcare
David Jefferys, MD, senior vice president, Eisai Europe Ltd.
Lisa Jenkins, PhD, senior regulatory consultant, Kendle Inc.
*Denotes session leaders who are speaking
Visit RAPS.org/ac2009 for the most up-to-date list of speakers.
James Kelly, PhD, senior director, regulatory affairs, Roche
Molecular Systems*
Joel Kent, RAC, manager, quality and regulatory affairs, GE
HealthCare*
Robert Klepinski, JD, regulatory attorney, Frederickson &
Byron PA
Mark Kramer, RAC, chief strategist/vice president,
regulatory affairs, GE Healthcare
Eric Langer, managing partner, BioPlan Associates Inc.*
Deborah Lavoie, JD, RAC, director, regulatory affairs
program, GE Healthcare*
Daniel Mannix, PhD, group director, oncology, Bristol-Myers
Squibb International
Munish Mehra, PhD, managing director, Global Drug
Development Experts LLC*
Elaine Messa, RAC, director, medical device quality
systems and compliance practice, Becker &
Associates Consulting Inc.*
Gloria S. Miller, RAC, CQA auditor, PPD Inc.
Susan Mondabaugh, PhD, vice president, regulatory affairs,
Hurley Consulting Associates Ltd.*
Harindranath Nagaradona, PhD, associate director,
pharmaceutical consulting, Kendle Inc.
Suzanne O’Shea, JD, counsel, Baker & Daniels LLP*
Miriam Provost, PhD, senior consultant medical devices,
Biologics Consulting Group Inc.*
Jillian Reed, principal, Reed Technical Associates
Rose Romeo, PhD, executive director, RA/QA, XDx*
Nancy Ruth, RAC, director, medical devices, CanReg Inc.*
Peter Ruys, PhD, senior regulatory expert, Obelis SA*
Robert Schiff, PhD, RAC, CEO, Schiff & Company Inc.
Raymond Seda, MBA, RAC, manager, Latin America,
corporate regulatory affairs, Zimmer Inc.*
Adriana Serrão, regulatory affairs director, Latin America,
GE Healthcare–Brazil*
William Sietsema, PhD, vice president clinical and
regulatory strategic planning, Kendle International Inc.
Mary Speagle, RAC, executive director, Canadian
regulatory affairs, CanReg Inc.*
Alan Stricker-Krongard, PhD, chief scientific officer,
preclinical services, Charles River
Sara Stults, group director, US pharmaceutical law and
promotion compliance, Bristol-Myers Squibb Co.
Yuka Suzuki, PhD, director, Office of Medical Devices,
Pharmaceuticals and Medical Devices Agency*
Michael Swit, Esq., vice president, The Weinberg Group Inc.*
Kyoichi Tadano, PhD, director, International Affairs Division,
Office of Planning and Coordination, Pharmaceuticals
and Medical Devices Agency
Bradley Thompson, MBA, JD, RAC, attorney, Epstein
Becker & Green PC*
Rainer Voelksen, executive, international regulatory affairs,
GE HealthCare
Chang-Hong Whitney, MBA, president, Whitney Consulting Ltd.*
John Wood, vice president, regulatory affairs, Lithera Inc.
Amy Wright, PhD, RAC, principal scientist, CIBA Vision
Corp., Cell Biology*
Elisabethann Wright, partner, Hogan & Hartson
About Philadelphia
Philadelphia, a dynamic place where big city excitement meets hometown charm, awaits
your arrival. Famous as the birthplace of “life, liberty and the pursuit of happiness,” the
cradle of liberty offers much more than cobblestone streets and historic landmarks. Cultural,
culinary, artistic and ethnic treasures abound in this city and the surrounding countryside.
And, of course, the greatest concentration of US history can be found just blocks away at
Independence National Historical Park, including the Liberty Bell and Independence Hall.
Best of all, Philadelphia’s compact downtown provides all of this and much more within a

13–16 September 2009 :: Philadelphia :: Pennsylvania Convention Center :: RAPS.org/ac2009

short walk or cab ride from the Pennsylvania Convention Center and any downtown hotel.

Visit RAPS.org/ac2009 for travel information.

21
5635 Fishers Lane
Suite 550
Rockville, MD 20852
USA

2009
RAPS

annualconference
&exhibition
13–16 September 2009
Philadelphia
Pennsylvania Convention Center

RAPS.org/ac2009

Succeed in the new

regulatory landscape