RSSL Pharma, a leader in the supply of technical outsourcing solutions and professional training to the international pharmaceutical industry, is organizing a workshop on the topic ""Taking OTC''s and Herbal Medicinal Products from USA to Europe" on October 2, 2002, the second day of CPhI Worldwide at the Conference Room 501.
At the Workshop, Dr. Brigitte Friese will speak about the legislative framework and changes coming in Europe in this regard. The other speakers at the Workshop include Nadia Boispertuis, Jeff Kaufman, Dr. Martin Cranmer, Dr. Martin Cranmer, Dr. Thilo Schmierer, Dominic Parry, Anthonia Chalmers, Jeff Kaufman.
The Workshop will deal with the topic likeNotice to Applicants - CTD - Expert Reports, Formulation and culture, Using the USP vs the EP, Herbal Drug Monographs, Analytical Testing, Stability Indication Assays, Determination of Expiry limits using
USA data, The latest situation with GMP in Europe, GMP for Active Pharmaceutical Ingredients, GMP requirements for excipients, Pre-clinical data requirements, Undertaking human trials in Europe for OTC''s and Herbals: The Clinical Trials Directiveand Costs and timing for preparation of Applications for & grant of Marketing Authorisations.
The detailed programme list of the Workshop:
Wednesday October 2, 2002; 10.00 - 17.00 hrs
Conference Room 501
09.00 - 10.00 Registration.
10.00 - 10.30 Legislative framework - changes coming in Europe. Forstmann Kleist Friese - Dr. Brigitte Friese
10.30 - 11.00 Notice to Applicants - CTD - Expert Reports. Yarra SA - Mrs. Nadia Boispertuis
11.00 - 11.20 Formulation and culture. Yarra SA - Mr. Jeff Kaufman/Dr. Martin Cranmer
11.20 - 11.45 Coffee Break
11.45 - 12.15 Using the USP vs the EP. Yarra SA - Dr. Martin Cranmer
12.15 - 12.45 Herbal Drug Monographs. Agon Pharma GmbH - Dr. Thilo Schmierer
12.45 - 13.45 Lunch Break.
13.45 - 14.15 Analytical Testing, Stability Indication Assays, Determination of Expiry limits -using USA data. Yarra SA - Dr. Martin Cranmer
14.15 - 14.45 The latest situation with GMP in Europe, GMP for Active Pharmaceutical Ingredients, GMP requirements for excipients. RSSL Pharma - Mr. Dominic Parry
14.45 - 15.05 Pre-clinical data requirements. MPS Medizinischer Pharmaberatungsservice - Dr. Brigitte Lehmann
15.05 - 15.30 Coffee Break.
15.30 - 16.00 Undertaking human trials in Europe for OTC''s and Herbals: The Clinical Trials Directive. RSSL Pharma - Mrs. Anthonia Chalmers
16.00 - 16.20 Costs and timing for preparation of Applications for & grant of Marketing Authorisations. Yarra SA - Mr. Jeff Kaufman
16.20 - 16.30 Questions and Answers
Panel Discussions on Oct 1 in conference room 501/502/503
Panel Meeting Pharma --- Fine Chemical Industries
Tuesday October 1, 200216.30 - 18.00 hrs
Conference Rooms 501/502/503
The panel meeting is organised by Dr. Peter Pollak, Fine Chemical Business Consultant from Switzerland
For the first time CPhI has organized a panel discussion between the pharma and fine chemical industry, an event which needs to be attended!! The Pharma and Fine Chemical panel members are the following keynote persons from the major industry companies:
Chairman KPMG - Guenther Eberhard
Pharma Panelists
AstraZeneca - Tord Svedberg
Bayer - Hans Moser
Eli Lilly - Joe Sutton
Merck - Joe Colleluori - Director, Strategic Outsourcing
Roche - J. van Koeveringe - Head of pharma worldwide technical operations
Beta-Chem - Ichiro Shinkai
Fine Chemicals/Custom Manufacturers Panelists
Avecia - David Killworth - Vice President
Bayer - Rudolf Hanko - Head of BU Fine Chemicals
Clariant - David Maddox - Head of BU life science molecules
DSM - Hubert Stückler - Senior Vice President - Global New Business Devel.
Lonza - Lukas Utiger - Senior Vice President/Head of Exclusive Synthesis
Degussa AG - Dr. Peter Nagler - President of fine chemicals
The keynote topics of the panel meeting will be:
* Rationale for outsourcing
* Key elements of a cooperation
* Intellectual property rights
* Preferred suppliers
* Future trends in outsourcing
* Western versus Far East vendors
* Cost transparency
After the panel meeting their will be a reception, where participants will be able to discuss further ideas with the panel members and attendees.
Expertised CPhI Committee
The highly qualified and international judging committee will gather again to establish the industry-oriented sessions of the CPhI Conference 2002. Their effort and support has resulted in the successful different CPhI Conferences over the past year.
The committee members are:
Mr. L. Calenti(ACIC Fine Chemicals)
Dr. J. Lubosch(Bayer AG)
Dr. P. Pollak(Fine Chemicals Business Consultant)
Mr. B. Leclercq(FMC BioPolymer)
Mr. J.P. Senet(Groupe SNPE)
Mr. D. Gibert(Isochem (Groupe SNPE))
Dr. H. Baumann(Merck KGaA)
Mr. J. Easson(Merck KGaA)
Mrs. M. Simpson(Thistle Enterprises Ltd.)..