Royal Pharmaceutical Society of Great Britain, London
Thursday 15 – Friday 16 April 2010
Monday 12 October 2009 08.00 Registration and Coffee 08:30 Welcome address and overview of the conference: Meaning of ‘Drug Quality - what we know & what we do not know
Mike Yelvigi, Wyeth Research, USA • Session 1: Drug product development and manufacturing (I)
Moderators: Mike Yelvigi, Wyeth, USA and Lembit Rägo, WHO, Switzerland 09:00 Design of quality from concept to clinic - application of quality concepts at early development phase (QbD) and impact on clinical outcome
Mahdi Fawzi, Wyeth Research, US0041 09:45 Using science and risk-based approaches to manage quality across the product lifecycle – what can we learn from other industries?
Tom Sam, Schering-Plough, Netherlands 10:30 Coffee break 11:00 FDA’s vision for regulation of a globalised drug manufacturing industry
Moheb Nasr, FDA, USA 11:45 Does the current thinking of QbD assure quality? - pros and cons
Linda Hakes, UCB/Schwarz Pharma, Germany 12.30 Lunch and poster viewing • Session 2: Drug product development and manufacturing (II)
Moderators: Tom Sam, Schering-Plough, Netherlands and Praful Sheth, Searpharm, India 13:30 Improving overall quality for commercial pharmaceutical products
Azita Gerhardt, Abbott, USA
14:15 Sustaining quality from development to commercialisation
Galen Radebaugh, Wyeth Research, USA
15:00 Implementation of quality by design - regulatory considerations
Elaine Moorefield, FDA, USA 15:45 Coffee break 16:15 WHO’s prequalification programme - what it is, why it is needed and its impact on quality
Lembit Rägo, WHO, Switzerland 17:00 Panel discussion 17.30-19.00 Welcome reception and networking
TUESDAY 13 OCTOBER
08:00 Coffee
• Session 3: Drug distribution and supply chain
Moderators: Elaine Moorefield, FDA, USA and Linda Hakes, UCB / Schwarz, Germany 08.30 Managing quality and accountability in outsourced operations
TBD 09:15 Managing quality in the distribution of medicines in a supply chain
Laurent Boer, UCB, Belgium 10:00 Coffee break 10:30 Counterfeit drugs - impact on quality management of supply chain
Andrew Jackson, Novartis Security Operations, USA 11:15 Quality and regulatory framework for prescription drugs, challenges of worldwide variations in regulatory requirements for prescription drugs – pros and cons
Praful Sheth, Searpharm, India 12:00 Panel discussion 12:30 Lunch and poster viewing • Session 4: Patient Administration
Moderators: Tom Sam, Schering-Plough, Netherlands & Galen Radebaugh, Wyeth Research, USA 13:30 Understanding patient needs and physician’s intent in the administration of medications-a pharmacist’s perspective
Jim Steven, University of Michigan, USA 14:15 Managing quality in hospital dispensing
Jim Steven, University of Michigan, USA 15:00 Coffee break 15:15 Understanding patient needs in the preparation of medication label - are we there? – from a regulatory and an industry standpoint
TBD 16:00 Managing quality at the local pharmacy level - challenges of storage/handling, segregation, contamination, label control, expiration control
Eeva Teräsalam, Association of Finnish Pharmacists, Finland 15:45- 17:00 Wrap-up and conclusion
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