PANAKEIA /LASO PHARMA PVT LTD.

MEDICAL REPRESENTATIVES
Medical representatives are also known as medical sales representatives or pharmaceutical sales representatives . Their job is to learn as much as they can about the medical products they sell to doctors and other health -care personnel. Medical sales includes products such as prescription and over-the-counter medications, as well as medical supplies that patients require for conditions, such as diabetes. The medical representative needs a combination of sales skills and medical knowledge to do the job.

JOB DESCRIPTION
Employers normally prefer graduates with relevant qualifications in life sciences, pharmacy, medicine, nursing or dentistry.
New recruits normally receive an initial period (up to six months) of intense training, following which they may shadow experienced sales staff before commencing work on their own . Medical representatives are the key point of contact between pharmaceutical and medical companies and healthcare professionals:

i. ii. iii. iv.

promoting product awareness, answering queries, providing advice and introducing new products.
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KEY RESPONSIBILITIES
organising appointments and meetings with community and hospital-based healthcare staf f identifying and establishing new business negotiating contracts demonstrating/presenting products to healthcare staf f including doctors, nurses and pharmacists undertaking relevant research maintaining detailed records making presentations

CONTINUED

attending/organising trade exhibitions, conferences and meetings. managing budgets reviewing sales performance writing reports and other literature . CRM Customer potential evaluation. Knowledgeable in recent developments in Anatomy.

KEY SKILLS
commercial awareness maturity Confidence patience strong interpersonal skills communication skills organisational skills sales skills are essential.
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COMPETENCY MAPPING
These national competency standards were developed to serve as the basis of the MRCC Certification for Biopharmaceutical Representatives in the US. They are further intended for use by medical representatives, their employers and their customers to measure capability, performance and to map growth and professional development needs. Employers and medical representatives will utilize these standards to evaluate training and professional development initiatives to assure participants are gaining knowledge and skills that meet the requirements of certification and the needs of patient care

 In this study, per formance domains, content domains, tasks, and topics were validated using scales for impor tance , criticality, and frequency.

The impor tance scale of fered insight into how essential the domain is for the medical representative.
Criticality (potential for harm) and frequency (how of ten) scales also supplied suppor t for decision making about the job analysis, which should be considered when making decisions about the MRCC examination. Data collected in the validation study por tion of the job analysis study give clear evidence that the per formance domains, content domains, tasks, and topics are accurate elements of practice for the medical representative working in the biopharmaceuti cal field.

HOW SHOULD THE STANDARDS BE USED?

These national competency standards were developed to serve as the basis of the MRCC Certification for Biopharmaceutical Representatives in the US. They are further intended for use by medical representatives, their employers and their customers to measure capability, performance and to map growth and professional development needs Employers and medical representatives will utilize these standards to evaluate training and professional development initiatives to assure participants are gaining knowledge and skills that meet the requirements of certification and the needs of patient care.
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THE COMPETENCY STANDARDS

Five per formance and content domains (major elements of practice and major bodies of knowledge) form the basic organizational structure for the standard.

Domains Per formance domains are the major responsibilities or duties that define the role of medical representatives in the biopharmaceutical field.
Content domains are the major topics or bodies of knowledge that medical representatives in the biopharmaceuti cal field must possess in order to of fer competent ser vice. Compliance and Ethical Conduct
I. Regulatory Compliance and Ethical Conduct II. Customer Interaction III. Administration IV. Clinical and Therapeutic Knowledge V. Marketplace Knowledge

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DOMAIN I REGULATORY COMPLIANCE AND ETHICAL CONDUCT:

T h e m e d i c a l r e p r e s e n t a t i v e m u s t p r ote c t t h e i n te r e s t s o f p a t i e n t s a n d o t h e r s t a ke h o l d e r s by c o m p l y i n g w i t h fe d e r a l , s t a te , a n d l o c a l l aw s , r e g u l a t i o n s , g u i d e l i n e s , a n d p o l i c i e s . This includes completing compliance training, conducting business activities in an e t h i c a l m a n n e r, p r ov i d i n g a p p r o p r i a t e p r o d u c t i n fo r m a t i o n , a n d d o c u m e n t i n g a n d managing resources. A . C o m p l e te r e q u i r e d c o m p l i a n c e t r a i n i n g a n d c e r t i fi c a t i o n u s i n g a p p r o v e d s o u r c e s to p r o te c t t h e i n te r e s t s o f p a t i e n t s a n d ot h e r s t a ke h o l d e r s . B . C o n d u c t d a i l y b u s i n e s s a c t i v i t i e s i n a n e t h i c a l m a n n e r i n o r d e r to p r o te c t t h e i n te r e s t s o f p a t i e n t s a n d ot h e r s t a ke h o l d e r s . C . B u i l d t r u s t w i t h c u s to m e r s by u n d e r s t a n d i n g a n d c o m p l y i n g w i t h f e d e r a l , s t a te , a n d l o c a l l aw s , r e g u l a t i o n s , g u i d e l i n e s , a n d p o l i c i e s i n o r d e r to p r ote c t t h e i n te r e s t s o f p a t i e n t s a n d ot h e r s t a ke h o l d e r s . D . E n s u r e a p p r o p r i a t e a n d t i m e l y d e l i v e r y o f p r o d u c t i n fo r m a t i o n by c o m p l y i n g w i t h f e d e r a l , s t a te , a n d l o c a l l aw s , r e g u l a t i o n s , g u i d e l i n e s , a n d p o l i c i e s i n o r d e r to f a c i l i t a t e t h e p r o p e r u s e o f p r o d u c t s by c u s to m e r s . E . D o c u m e n t t h e u s e o f r e s o u r c e s u s i n g e s t a b l i s h e d p r o c e d u r e s i n o r d e r to d e m o n s t r a t e c o m p l i a n c e w i t h fe d e r a l , s t a te , a n d l o c a l l aw s , r e g u l a t i o n s , g u i d e l i n e s , a n d p o l i c i e s a n d to m a n a g e r e s o u r c e s e f fe c t i v e l y.

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DOMAIN II: CUSTOMER INTERACTION:

The medical representative must suppor t informed decision making in accordance with customer and patient needs, customer and patient feedback , settings, and applicable federal, state, and local laws, regulations, guidelines, and policies. The medical representative must identify appropriate product options, address payer -access challenges, provide fair, balanced, and accurate information, and maintain the physical integrity of the product and its packaging. A . Interact with customers in compliance with federal, state, and local laws, regulations, guidelines, and policies and in accordance with the setting, applicable laws, regulations, guidelines, policies, and ethical requirements to identify customer needs. B. Identify diagnostic or therapeutic options that address patient and customer needs (e.g., medical conditions, treatment needs, payer policies) through collaboration with the customer in order to suppor t informed decision making. C. Address payer-access challenges for customers in compliance with federal, state, and local laws, regulations, guidelines, and policies in order to suppor t appropriate diagnostic and therapeutic options.
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 D. Provide customers with approved fair, balanced, and accurate information consistent with applicable federal, state, and local laws, regulations, guidelines, and policies to validate appropriate diagnostic or therapeutic options and suppor t informed decision making by the customer and the patient. E. Use product resources (e.g., educational materials and programs, samples) in accordance with their intended purposes to suppor t appropriate product use and indication.

F. Maintain the physical integrity of the product and packaging by adhering to all federal, state, and local laws and regulations in order to protect the interests of customer s, their patients, and other stakeholders.
G. Gather feedback from the customer through regular interaction to understand the diagnostic or therapeutic experience, identify additional needs, and comply with repor ting obligations.

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DOMAIN III: ADMINISTRATION:

The medical representative must complete organizational and administrative tasks in accordance with federal, state, local, and corporate laws, regulations, guidelines, and policies. This includes implementing corporate strategies, adapting to market conditions, maintaining business relationships, recording activities, and promoting product utilization. A . Implement business plans in accordance with corporate strategy in order to promote appropriate product utilization and adapt to market conditions. B. Communicate ef fectively and responsibly with all internal stakeholders using appropriate media in order to maintain business relationships and achieve business plans. C. Record activities (e.g., distribution of samples, leave behinds) using established procedures in order to demonstrate compliance with federal, state, and local laws and regulations.

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DOMAIN IV: CLINICAL AND THERAPEUTIC KNOWLEDGE:

C l i n i c a l a n d t h e r a p e u t i c k n ow l e d g e i s e s s e n t i a l to e f fe c t i v e c o n s u l t a t i o n w i t h c u s to m e r s a n d i n c l u d e s b r o a d l y a p p l i c a b l e c o n c e p t s a n d te r m i n o l o g y A . P r e s c r i b i n g I n fo r m a t i o n a n d S a fe t y ( e . g . p r o d u c t l a b e l i n g , a d v e r s e e v e n t s , r e p o r t i n g , p r o d u c t s a fe t y, p o s t - m a r k e t i n g s u r v e i l l a n c e d a t a ) B . A n a to m y a n d P hy s i o l o g y ( D r u g I n te r a c t i o n w i t h t h e B o d y ) ( e . g . b o d y s t r u c t u r e , c e l l s a n d c e l l f u n c t i o n , c o m p o n e n t s a n d b a s i c f u n c t i o n s o f m a j o r b o d y s y s te m s ) C. Medical Ethics (Within Practice of Medicine) (e.g. risk/benefit analysis, quality of life, m o r t a l i t y, m o r b i d i t y ) D. Pharmacology (e.g. pharmacodynamics, pharmacokinetics, absorption, distribution, m e t a b o l i s m , e l i m i n a t i o n , h a l f l i fe , i m p a c t o f d r u g s o n c e l l f u n c t i o n s , d o s a g e administration, method of action) E . D i a g n o s t i c Te s t s a n d E v a l u a t i o n P r o c e d u r e s ( e . g . d i a g n o s t i c p r o c e s s ) F. C l i n i c a l Tr i a l s a n d Re s e a r c h ( e . g . e v i d e n c e - b a s e d m e d i c i n e , p h a s e s o f c l i n i c a l t r i a l s , standard components of trial) G . P r o d u c t L i fe c yc l e ( e . g . p h a s e s o f l i fe c yc l e f r o m r e s e a r c h to g e n e r i c s , d i s t r i b u t i o n channels)

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 Domain V: Marketplace Knowledge: Knowledge of the marketplace ensures the medical representatives ability to interact ef fectively and appropriately in the environments in which they work . A . Concepts in Managed Care (e.g. payers, provider s, distributors, managed market channels, Medicare, Medicaid, commercial, employers, GPOs, cost -containment methods, influence of deliver y of healthcare and deliver y settings) B. Formular y Status (e.g. types, pharmacy and therapeutic committee process) C. Healthcare Settings (e.g. types of settings, prescribing dif ferences ) D. Medical Training and Scope of Practice for Various Healthcare Providers

E. Role of Standard Setting Organizations and Their Impact on Customers

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CONCLUSION:EXAMINATION CONTENT
The validation process within the job analysis study determined the blueprint for the certification examination. The following weights were approved and reflect the measurements of importance, criticality and frequency within the validation study. These weights will be applied to the examination question bank as examinations are created and delivered. Domains: I. Regulatory Compliance and Ethical Conduct -25.9% II. Customer Interaction -30.4% III. Administration -7.9% IV. Clinical and Therapeutic Knowledge -24.8% V. Marketplace Knowledge -11 .0%

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Thank You!!

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