Alistair Davidson, GlaxoSmithKline

1
Introduction of the Agenda

• Alistair Davidson, GlaxoSmithKline
• Chair of Programme Organising Committee

2
Welcome and Thanks
3
2004-2008 Regulatory change

• Information sharing and openness
• Clinical trial registers
• Open agency-Industry fora
• Earlier development/regulatory discussion
• Scientific Advice
• Pre-application consultation meetings
• Longer term agency planning
• EMEA RoadMap to 2010
• USA FDA Critical Path Initiative
• Harmonisation and co-operation
• ICH GCG
• ASEAN
• Expansion of European Union implementation of
  New Medicines Legislation
• New guidelines Q8, Q9, Q10

4
Joint agency co-operation agreements 2006

• US DHHS/Institut Pasteur MOU on capacity to
  detect flu viruses
• EMEA/US FDA Extend confidentiality agreement to
  vaccine development, orphan products etc
• AFSSAPS (France)/US FDA Agreement on information
  exchange
• China SFDA/US FDA/Health Canada co-operation in
  registration, supervision and inspection
• Japan Ministry of Trade/US Dept of Commerce
  co-operation on intellectual property/counterfeits
  
• Canada/France Health Ministries co-operate to
  fight infectious diseases
• Australia TGA/Health Canada sharing information
  on evaluating new biological drug submissions
• Swissmedic/Australia TGA exchange info on
  regulation of pharmaceuticals and devices

5
2004-2008 Regulatory change

• Globalisation of RD
• Asia as centre of excellence
• China as magnet for investment
• Action on counterfeits IMPACT
• Business practice
• IFPMA and EFPIA marketing codes updated
• Ethics bar raised within Industry and Agencies,
  including establishment of sanctions
• Judicious referencing CPP and Article 58
• Avian flu and pre-pandemic preparedness
• Risk/benefit debate and drug life-cycle management

6
Agenda

• Global picture how does Asia fit in?
• Good Regulatory Practice
• Quality
• ASEAN Harmonisation
• Global drug development Asias role
• Industry self-regulation and business ethics
• Pharmacovigilance and information management
• Future challenges

7
Impact Participation

• Open discussion
• Share ideas
• Question the presenters/panels
• Network
• Feedback to Programme Organising Committee

8
Enjoy the meeting!