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.)..