2010 TRAINING SESSION: ISTANBUL

THE EUROPEAN PHARMACOPOEIA 7TH EDITION

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

DRAFT PROGRAMME

9-10 December 2010 Location: Mvenpick Hotel, Istanbul, Turkey

TRAINING SESSION 7TH EDITION

THURSDAY 9 DECEMBER 2010 8:00-9:00 9:00-9:10 9:10-9:15 9:15-9:35 9:35-9:50 9:50-10:05 Registration Opening & Welcome address General introduction to the Programme Turkish Medicines Regulations Turkish Pharmacopoeia: A Historical Perspective Activities and role of the Turkish Pharmaceutical Association

10:05- 10:35 European regulations for medicines: How does the system work? Relationship between EU/EMEA and the EDQM of the Council of Europe. Place and roles of the EDQM and the European Pharmacopoeia. General organisation of the EDQM. 10:35-11:00 Coffee break 11:05-11:30 General concepts in the European Pharmacopoeia: theory and rationale 11:30-12:00 Specific monographs: a guide through the different sections 12:00-12:30 How to use the general monograph Substances for pharmaceutical use and decision trees for impurities. How to interpret chromatograms and list of impurities. 12:30-13:00 Open discussion with the panel of speakers 13:00-14:00 Lunch break 14:00-14:30 How to participate in the elaboration of the European Pharmacopoeia 14:30-15:15 European Pharmacopoeia reference standards: definitions, types of standards, establishment and production, role and use 15:15-15:45 Open discussion with the panel of speakers 15:45-16:15 Coffee break 16:15-16:45 General presentation of the Certification Procedure The place of certification as a regulatory tool - Comparison of CEP and Active Substance Use of a CEP 16:45-17:00 Open discussion 17:00-18:00 Questions and answers Topics covered: General questions on the EDQM & the European regulatory framework; Technical questions on Ph. Eur. monographs, Certification 18:00 Cocktail

PROGRAMME:

FRIDAY 10 DECEMBER 2010 (MORNING) 8:00-9:30 Content of the dossier Validation at receipt Highlight the Top Deficiencies identified in 2009: concrete examples Electronic submissions

9-10 December 2010 Location: Mvenpick Hotel, Istanbul, Turkey

9:30-10:00

TRAINING SESSION 7TH EDITION

10:00-10:15 Open discussion with the panel of speakers 10:15-10:45 Coffee break 10:45-11:15 Revisions of CEPs 11:15-11:45 The EDQM inspection programme 11:45-12.15 Open discussion with the panel of speakers 12:00-14:00 Lunch break OPTIONAL - ADDITIONAL CERTIFICATION SESSIONS AT NO EXTRA CHARGE

Two Certification Case Study sessions will be held in parallel twice: 14:00-15:00 and 15:30-16:30 How to set specifications for impurities (e.g. Substance covered by a monograph without transparency statement) OR How to prepare a revision application

FOR REGISTRATION OR MORE INFORMATION PLEASE VISIT THE WEBSITE: www.edqm.eu

PROGRAMME: