Exploring the current and future situation worldwide
A joint event of IPEC Europe, IPEC-Americas, IQ Consortium and APV.
TARGET GROUP
Scientists and managers working in the regulatory field and/or research and development.
REGISTRATION FEE
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Price
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Industry
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1.290,00 €
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Authority / University
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645,00 €
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Students
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200,00 €
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All prices are VAT-free according to § 4.22 UStG
HOTEL RESERVATION
Pullman Brussels Centre Midi
Place Victor Horta 1, 1060 Brussels, Belgium
+32 2 528 98 14 - H7431-sb@accor.com
Participants should make their own hotel reservation referring to the APV seminar. Deadline for special conference rate: 14 August 2022. Special rate: Single room incl. breakfast from 150,00 € per night.
Wednesday 14 September 2022, 12:00-18:00 h
Welcome & Introduction
Kevin Hughes, Colorcon Limited, Representative IPEC Europe
Jason Melnick, Eli Lilly and Company, Representative of of IQ consortium David R. Schoneker, Black Diamond Regulatory Consulting, Representative IPEC-Americas
Mahmud Yunis, Biogrund GmbH, Representative APV e.V.
Background and history: legal and technical aspects
Overview of TiO2 – Technical review
- What are the implications and realities of replacing titanium dioxide?
- TiO2, why has it been used so much?
Mike Tobyn, Bristol-Myers Squibb Pharmaceuticals Ltd
History of why we are in this situation now – EU and global situation
Bram Baert, Lonza Group
Kevin Hughes, Colorcon Limited
Overview on the regulatory framework
- Difference between E171 vs. TiO2
- Why is it ‘easier’ to remove E171 from food products than from pharmaceuticals?
Michael Weidner, Kozianka & Weidner Rechtsanwälte
Toxicological considerations of TiO2
Thomas Broschard, Merck Healthcare
Panel discussion
Networking dinner
Thursday 15 September 2022, 09:00-16:00 h
Current and future situation of TiO2 /E171
EMA’s approach
EMA (TBC)
What is necessary from OTC manufacturers point of view?
Joachim Hermann, Dr. Willmar Schwabe GmbH
What is necessary from OTC/RX mid-size manufacturers point of view?
Hendrik Schuette, Krewel Meuselbach GmbH
What is necessary from RX manufacturers point of view?
EFPIA (TBC)
What is necessary from regulatory affairs point of view?
Guido Holzem, Grünenthal GmbH
Innovative Initiative in clinical studies
EFPIA (TBC)
Technical challenges from different coating producers' point of view
A joint session of several companies
Calcium Carbonate as alternative
Calcium Carbonate Association Europe
Challenges from a capsules shell producer point of view
Julein Lamps, Lonza Group
Global situation:
- United Kingdom
- Canada
David R. Schoneker, Black Diamond Regulatory Consulting, LLC
- United States
- Austria/New Zealand, Middle East, MERCOSUR, others
David R. Schoneker, Black Diamond Regulatory Consulting, LLC
Safety of E171 – status quo
David Lockley, Chair of TDMA CLH Task Force (pre-recorded talk) and David R. Schoneker, Black Diamond Regulatory Consulting, LLC for live Q&A
Panel discussion
Closing remarks
Programme is subject to change
Download the programme
