The International Pharmaceutical Excipients Council Europe Forum February 5, 2015 The negresco HOtel, Nice, France About IPEC Europe Registration and further information IPEC Europe, the International Pharmaceutical Excipients Council Europe, is a non-profit association that serves the interests of producers, distributors and users of pharmaceutical excipients. Together with its sister associations, IPEC Americas, IPEC Japan and IPEC China, the Council is a member of IPEC Federation whose global membership extends to more than 200 companies. In 2008, IPEC Europe initiated with other industry experts the development of a certification scheme for excipients suppliers that has become the free-standing association EXCiPACT™ in January 2014. The registration fee is 200 Euro for IPEC Europe member companies and 600 Euro for non-IPEC Europe members. This fee includes the seminar material and covers coffee breaks, lunch and networking dinner. The fee does not cover accommodation and travel arrangement. IPEC Europe offers a unique forum for members to exchange good practices and to develop harmonised standards for pharmaceutical excipients. It strives to continuously promote and achieve worldwide acceptance and use of the IPEC developed guidelines as a means of improving and ensuring quality, saftey, and functionality of pharmaceutical excipients. To register or obtain further information please contact: IPEC Europe Tel: +32 (2) 213 74 40 | E-mail: [email protected] or visit www.ipec-europe.org this Flyer IS SPONSORED BY In 2015, IPEC Europe asbl counts 70 full members, plus three associated and two co-opted members. Activities are organised through Committees or Working Parties, the activities of which are communicated during the Annual General Meeting and in IPEC Europe newsletters, which are regularly posted on the news section of IPEC Europe’s website. Since 1999, BIOGRUND has been developing and producing special powder preparations for film coating, sugar-coating, colouring and tableting, which are used in pharmaceutical products, food and nutritional supplements and cosmetics all over the world. These one-step products minimize and facilitate working times for all applications. Easy, fast and reliable! THE IPEC EUROPE Excipients forum IS SPONSORED BY SILVER SPONSORs BRONZE SPONSOR IPEC EUROPE ASBL — Rue du luxembourg 16B, B-1000 Brussels t +32 (2) 213 74 40 | E [email protected] | www.ipec-europe.org IPEC Europe excipients forum 2015 IPEC Europe excipients forum 2015 IPEC Europe Excipients Forum 2015 Changing Times, Changing Practices? Focus on Excipient Quality and Functionality. Forum Programme THURSDAY, February 5, 2015 08:15 Registration desk Session Chair — Karine Roth, IPEC Europe Board Member 08:45 Opening Remarks — Dr Frank Milek, IPEC Europe Chair 09:00 Excipient Functionality & Pharmacopeia — Dr Susanne Keitel, EDQM Director 09:40 10:20 Good Trade & Distribution Practices: Current & Future Trends — Dr Sabine Kopp, Group Lead, Medicines Quality Assurance WHO 10:50 Updates on USP’s Proposed General Information Chapter, Good Distribution Practices <1083> – An Overarching Chapter — Catherine Sheehan, Sr. Director, Excipients Global Science and Standards Division USP 11:30 Chinese Pharmacopeia 2015: New Milestone of Excipients Standards in China — Jessica Zheng, IPEC China Liaison Committee Chair, Merck 12:10 EU GMP Part 1: Chapter 5, A Review of the Latest Update — Carl Mroz, IPEC Europe Quality & Regulatory Affairs Committee Chair, Colorcon 12:50 Lunch Session Chair — Liz Meehan, IPEC Europe Board Member 14:00 The Formalized Risk Assessment for Excipients – A Practical Approach — Frithjof Holtz, IPEC Europe Vice-Chair, Merck 14:30 The Revised IPEC Significant Change Guide: Content, Application and Benefit to Manufacturers and Users — Dr Iain Moore, Croda 15:10 Technically Unavoidable Particles: A New Guideline for Suppliers and Users — Priscilla Zawislak, IPEC Americas Chair-Elect, Ashland 15:40 Coffee Break 16:10 Co-Processed Excipients — Dr Hubertus Folttmann, BASF SE 16:40 Alcohol-Induced Dose Dumping — Dr Thomas P. Friebe, IPEC Europe Chair ADD WG, Evonik 17:20 Overall Q&A Session 17:30 Closing Remarks — Dr Frank Milek, IPEC Europe Chair Coffee Break *** 19:30 Cocktail 20:00 Gala Dinner — The Negresco HOtel Credits: Anna M. Stevenson, Claude Meisch, Timo Newton-Syms | commons.wikimedia.org Programme subject to change I P EC E u rop Ann u e al Ge nera l Meet ing 06.02 .2015
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