GCP Workshop 17'18'9'2001

1
GCP Workshop17.-18.9.2001

• Introduction to the VICH GCP GL
• - History and Background
• Liisa Kaartinen
• EWP Chairperson

2
Introduction to the VICH GCP GL- History and
Background

• GCP GL one of the first of the efficacy
  guidelines developed in the VICH process

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
3
Introduction to the VICH GCP GL- History and
Background

• EU GCP guideline in 1991
• 7AE1a in Volume 7A
• US Conduct of Clinical Investigations
  Responsibilities of Clinical Investigators and
  Monitors for Investigational New Animal Drug
  Studies in 1992
• no GCP guideline in force in Japan

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
4
Introduction to the VICH GCP GL- History and
Background

• VICH GCP WG started in 1997
• chaired by Dr. Vic Cracknell, FEDESA
• members in the Working Group
• Authorities Industry
• USA/FDA AHI
• EU FEDESA
• Japan MAFF Japan JVPA
• Observers
• Australia
• New Zealand

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
5
Introduction to the VICH GCP GL- History and
Background

• concept paper produced by Topic Leader based on
  the EU GCP guideline
• the first document was circulated to the WG
  members on 9th January 1997.

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
6
Introduction to the VICH GCP GL- History and
Background

• The major items
• Structure and content of clinical study reports
• Documents permitting evaluation of the conduct of
  a trial and the quality of the data produced
• .

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
7
Introduction to the VICH GCP GL- History and
Background

• .
• Definition of site investigator responsibilities
  - personal liabilities
• Definition of monitor function
• Inspection/auditing and quality assurance
• Necessity of pre-trial protocol review

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
8
Introduction to the VICH GCP GL- History and
Background
1st VICH GCP WG meeting, Brussels, 6-8 May 1997

• All the topics could be discussed
• Many details were agreed
• Missing items
• Animal welfare
• Also some other points were adopted from the US
  guideline or from the draft Japanese guideline.

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
9
Introduction to the VICH GCP GL- History and
Background
2nd VICH GCP WG meeting Bethesda, Maryland, USA
on 9-12 March 1998

• Dr. M. Schoenemann, FDA took very active role
• VICH SC WG to concentrate their effort on
  pharmaceutical products
• USDA was not participating in the VICH process at
  this point

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
10
Introduction to the VICH GCP GL- History and
Background

• The draft VICH GCP GL was signed for release for
  consultation by the VICH Steering Committee (step
  4) in October 1998
• In the EU CVMP release the document for six month
  consultation in the EU in December 1998

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
11
Introduction to the VICH GCP GL- History and
Background

• During the consultation process USDA got involved
  with the VICH process
• After the consultation
• chairmanship of the WG was transferred from
  industry to the regulatory authority
• Dr. Schoenemann, FDA, chaired the
  post-consultation meeting

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
12
Introduction to the VICH GCP GL- History and
Background

• Post-consultation VICH GCP WG meeting in Brussels
  on 15-16 November 1999
• Several parties had provided comments
• auditing and quality assurance issues
• animal welfare - not only the investigator but
  also the sponsor has responsibility on welfare
• WG finalised the guideline and signed it (Step 5)

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
13
Introduction to the VICH GCP GL- History and
Background

• The VICH Steering Committee signed the guideline
  (Step 7) in February 2000.
• The CVMP gave its final approval in July 200 and
  the date for coming into operation in the EU was
  in July 2001.

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001
14
Introduction to the VICH GCP GL- History and
Background

• The end

__________________________________________________
____________________________________________ Liisa
Kaartinen, National Agency for Medicines,
Finland GCP Workshop
17.-18.9.2001