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11-12 July 2017 – Location: EDQM Premises, Strasbourg, France PROGRAMME: TRAINING SESSION 2017 TRAINING SESSION: STRASBOURG

11-12 July 2017 Location: EDQM Premises, Strasbourg, France

PROGRAMME: TRAINING SESSION

2017 TRAINING SESSION: STRASBOURG

EUROPEAN PHARMACOPOEIA TRAINING SESSION - CHEMICALS 11-12 JULY 2017, STRASBOURG, FRANCE

Duration: 1.5 days (with optional extra afternoon CEP session) Working language: English ***

PROGRAMME (Subject to change)

TUESDAY, 11 JULY 2017

8:15-9:00

Registration

9:00-9:05

Opening & Welcome address

Dr Ulrich Rose, Deputy Head of the European Pharmacopoeia Dept., EDQM,

Council of Europe

9:05-9:45

European regulations for medicines: Place and role of the EDQM and the European Pharmacopoeia

Dr Ulrich Rose

9:45-10:30

General concepts in the European Pharmacopoeia: theory and rationale

Mrs Isabelle Mercier, European Pharmacopoeia Dept., EDQM, Council of Europe

10:30-11:00

Coffee break

11:00-11:30

Specific monographs: a guide through the different sections

Mrs Sylvina Iossiphova, European Pharmacopoeia Dept., EDQM, Council of

Europe

11:30-12:00

How to use the general monograph ‘Substances for pharmaceutical use’ and decision trees for impurities. Dr Ulrich Rose

12:00-13:00

Workshop and Discussion: How to interpret the tests for related substances including open discussions

Dr Ulrich Rose

13:00-14:15

Lunch break

14:15-14:40

How to participate in the elaboration of the European Pharmacopoeia

Ms Aurélie Barth, European Pharmacopoeia Dept., EDQM, Council of Europe

14:40-15:30

European Pharmacopoeia Reference Standards: Overview of the policy and process used to establish and distribute a reference standard

Dr Stefan Almeling, Deputy Head of the Laboratory Department, EDQM, Council of Europe

15:30-16:00

Open discussion with the panel of speakers

16:00-16:30

Coffee break

16:30-17:00

General presentation of the Certification Procedure

The place of Certification as a regulatory tool Comparison of CEP and Active Substance Master File

Ms Annick Dégardin, Scientific officer, Certification Department, EDQM, Council of Europe

17:00-17:30

Open discussion

11-12 July 2017 – Location: EDQM Premises, Strasbourg, France PROGRAMME: TRAINING SESSION WEDNESDAY 12 JULY 2017

11-12 July 2017 Location: EDQM Premises, Strasbourg, France

PROGRAMME: TRAINING SESSION

WEDNESDAY 12 JULY 2017 (MORNING)

9:00-10:00

Content of the dossier for a CEP - How to build a successful application

Mr Lennart Seidler, Scientific officer, Certification Department, EDQM, Council of Europe

10:00-10:30

Revisions of CEPs

Dr Andrew McMath, Head of the Revisions section, Certification Department, EDQM, Council of Europe

10:30-10:45

Open discussion with the panel of speakers

10:45-11:15

Coffee break

11:15-11:45

The EDQM inspection programme

Dr Sotirios Paraschos, Inspector, Certification Department, EDQM, Council of Europe

11:45-12:05

Use of a CEP

Dr Pascale Poukens-Renwart, Head of the Scientific Support section, Certification

Department, EDQM, Council of Europe

12:05-12:30

Open discussion with the panel of speakers

12:30-13:30

Lunch break

OPTIONAL - ADDITIONAL CERTIFICATION SESSIONS AT NO EXTRA CHARGE

Two Certification Case Study sessions - Each session will be held twice so participants have the option to attend both: 13:30-14:30 and 14:40-15:40

Workshop 1: How to prepare a CEP revision application

Dr Andrew McMath and Ms Chrystelle Defer, Certification Department, EDQM, Council of Europe

OR

Workshop 2: How to set a specification for impurities in active substances

Ms Annick Dégardin and Mr Lennart Seidler, Certification Department, EDQM, Council of Europe

FOR REGISTRATION OR MORE INFORMATION PLEASE VISIT THE WEBSITE:

www.edqm.eu

11-12 July 2017 – Location: EDQM Premises, Strasbourg, France PROGRAMME: TRAINING SESSION WEDNESDAY 12 JULY 2017

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