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Achievements since Thailand meeting 2001 Introduction to the Conference Program

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Bangkok meeting in 2001: a success. Most of the Asian countries represented at the ... Many events since the 2001 Bangkok meeting (progress and difficulties) ... – PowerPoint PPT presentation

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Title: Achievements since Thailand meeting 2001 Introduction to the Conference Program


1
Achievements since Thailand meeting
2001Introduction to the Conference Program
IFPMA Asia regulatory Conference Beijing 5-7
April 2004
  • Dr. Yves JUILLET

Chair IFPMA Asia Regulatory Committee Co-Chair
ICH-GCG
2
Bangkok meeting in 2001 a success
  • Most of the Asian countries represented at the
    highest level
  • Good interaction between the participants
  • A important step for new initiatives
  • At Regional and Country level
  • Within Industry
  • Influence on the ICH process

3
Since Bangkok
  • Regular meetings at regional level
  • ASEAN ACCSQ/PPWG
  • Sept 2001 Bali, Sept 2002 Siem Reap, July 2003
  • Myanmar
  • APEC conferences on E5
  • implementation
  • Taipei May 2001, Tokyo September 2002, Taipei
  • November 2003

4
Intense regulatory activitiy at country level
  • A few examples
  • Korea new regulatory legislations January-April
    2002
  • China regulation on registration and clinical
    trials 2002
  • Vietnam, Cambodia new regulations 2002

5
Industry Committees
  • IFPMA Asia Regulatory Committee officialized
  • EFPIA IRAG creation (International Regulatory
    Affairs Group) after ABPI TRAG
  • PhRMA IRAC
  • Regular interaction between working groups
    liaison members, teleconferences

6
Main difficulties identified by industry
  • Local specific requirements (real added value for
    public health?)
  • Lack of consistency with some ICH GLs outcomes
  • Risks of duplication

7
Main topics in discussion
  • Validation and API GMP issues
  • Zone III and IV stability GL
  • Local clinical trials and bridging studies (E5)
  • CTD
  • Free sales certificates and Educational Programs

8
Progress has been made, but sometimes too limited
  • Pragmatic attitude i.e. implementation of E5 GL,
    but different from a country to another
  • Direct contacts between authorities and industry
    representatives, invitation to participate in
    regulators meetings
  • Workshops on technical issues i.e. validation
    ASEAN region (2003)
  • Training activities i.e. drug development and
    review process in Thailand (2003)

9
An opportunity the new ICH GCG (I)
  • Initially (since 1999) interaction with ICH
    process, based on exchange of information and
    participation in meeting
  • Partnerships in Harmonisation Symposium
    organised with and for non-ICH regions/ countries
    at ICH6 (Osaka November 2003)
  • Participation of non ICH experts in GCG
    preparatory meetings
  • Program drafted and speakers identified jointly

10
An opportunity the new ICH GCG (II)
  • Decisions made by ICH SC (Nov 2003)
  • To propose regions having harmonisation
    activities to designate a permanent
    representative in the GCG (APEC, ASEAN, GCC,
    PANDRH, SADC)
  • To organize better interaction with regions
  • GCG agenda
  • Addressing questions and comments on ICH
  • GL, particularly at step 3 and at
    implementation
  • stage
  • Proposing to ICH SC topics and harmonisation
    actions

11
The new GCG how in practice
  • Official letter sent by GCG chairs to regions
    identified (December 2003)
  • Designation of participants to GCG on the way
  • Objective preparing the next ICH GCG agenda and
    participating in the meeting June 2004 Washington
    DC

12
Beijing 4th IFPMA Asia Regulatory Conference
  • Program built in order to address the main topics
    in discussion
  • Interaction between regulators (countries/regions)
    and industry/companies
  • Trying to define pragmatic solutions to issues
    identified

13
4th Asia Regulatory Conference
  • Plenary sessions on main issues
  • CTD and e-CTD, GCP and Clinical Trials, Ethnic
    Factors and Acceptability of Foreign Clinical
    Data, Good Regulatory Practices, Quality in
    Pharmaceuticals, Pharmacovigilance
  • Parallel workshops on specific important issues
    in regions or countries
  • Asean CTR/CTD, Clinical Trial in China,
    implementation of E5 in Asia, Good Regulatory
    Practices
  • Time for discussion in each session

14
Conclusion
  • Many events since the 2001 Bangkok meeting
    (progress and difficulties)
  • More and more regional harmonisation, but also
    some local decisions which might complicate
    and/or delay the patients early access to new
    drugs
  • Partnership a key word, positive complementary
    activities between regulators and industry
  • An opportunity the new GCG
  • The 4th IFPMA Asia Regulatory Conference has been
    built to match these needs
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