• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
 

Update regulatory standards landscape

on

  • 1,006 views

An update on standards development organizations and their impact on the exchange of regulatory information with health authorities.

An update on standards development organizations and their impact on the exchange of regulatory information with health authorities.

Statistics

Views

Total Views
1,006
Views on SlideShare
1,006
Embed Views
0

Actions

Likes
0
Downloads
43
Comments
0

0 Embeds 0

No embeds

Accessibility

Categories

Upload Details

Uploaded via as Microsoft PowerPoint

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment
  • Generic Drug User Fee Amendment (GDUFA)Biosimilar User Fee Act (BSUFA).
  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use Clinical Data Interchange Standards Consortium, IncLiaisons A: Organizations that make an effective contribution to the work of the technical committee or subcommittee for questions dealt with by this technical committee or subcommittee. Liaisons B: Organizations that have indicated a wish to be kept informed of the work of the technical committee or subcommittee. Liaisons C: Reserved for ISO/IEC JTC1. IHTDO International Health Terminology Development Organizationthe Medical Dictionary for Regulatory Activities - Maintenance and Support Services Organization Biomedical Research Integrated Domain Group
  • GS1 – standards for supply and demand chains – standard for barcodes comes from GS1M3(R2)Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for PharmaceuticalsFinalised Guideline:June 2009M3(R2)Concept PaperPresentation on M3(R2)Description: The recommendations of this revised guidance further harmonise the nonclinical safety studies to support the various stages of clinical development among the regions of European Union (EU), Japan, and the United States. The present guidance represents the consensus that exists regarding the type and duration of nonclinical safety studies and their timing to support the conduct of human clinical trials and marketing authorisation for pharmaceuticals.Implementation: Step 5EU: Approved by CHMP June 2009, issued as CPMP/ICH/286/95. Coming into operation in December 2009MHLW: Adopted on 19 February 2010, PFSB/ELD notification No. 0219-4FDA: Published in the Federal Register, Vol. 75, No 13, Docket No. FDA/2008/D/0470, p. 3471, 21 January 2010M3(R2) Q&As R2Questions & Answers: Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals
  • E3, E6, E8 – what are they?
  • The formal ICH procedure consists of 5 Steps : Step 1: Consensus Building Step 2: Confirmation of six-party consensus Step 3: Regulatory Consultation and Discussion Step 4 Adoption of an ICH Harmonised Tripartite Guideline
  • Step 4 signoff likely 11/12 – Final implementation probably July 2016 – not 2015.
  • HL7 – huge organization, very formal processes, everything takes a long time Run by a few exceptional individuals, difficult to get wide spread participationHL7 v3 – complexity is a problem,
  • DIA – EDM – essentially eCTD meta-data as document meta-dataIRISS – focus on EVMPD at the momentPhRMA - PhRMA EDC/eSource Taskforce, Electronic Regulatory Submissions (ERS) groupTIGes – RPS subgroup formed 2009– composed of FR, NL, DE, AT, UK, IRL, GR, EMA, EFPIA, EGA, EuropaBio and AESGP.
  • EU – an extension of xEVMPD

Update   regulatory standards landscape Update regulatory standards landscape Presentation Transcript