GLOBAL BIOANALYSIS CONSORTIUM on harmonization of bioanalytical guidance 2014, time for a status update

Transcription

1 GLOBAL BIOANALYSIS CONSORTIUM on harmonization of bioanalytical guidance 2014, time for a status update presented by Peter van Amsterdam, for GBC at 5 th JBF meeting, 6 March 2014 Tokyo, Japan

2 GBC What happened, what didn t? 45

3 First of all, a big thank you to all contributors Not in the least the HT-L and team members in the many TCs But also All supporting management of companies All scientists who joined the discussions in meetings and on the web And of course All supporting spouses waiting for their partner to stop the TC in the very early/very late hours And who we might forget to thank 46

4 Timeline of activities Harmonization Team Lead (HTL) identification HT team members identification SC & HT f-2-f touching base Decision not to have global meeting and start publication Under discussion in GBC-SC Start up phase: Steering Committee (SC) identification HT working on content HT preparing for FB (most) HT publishing in AAPS-J Open Letter to the regulators 47 Defining mission, vision, teams and Preparing execution of agreed (i.e. publication, global meeting,..) and intense communication at global meetings Understanding impact of delayed release of draft FDA guidance and adapt Prepare next steps of GBC today

5 What did we achieve? Bring together a global community of bioanalytical scientist and stimulate regional discussions on bioanalytical guidance Visualize the challenges of different global Guidance Highlight the need/desire for a harmonized (view on) Bioanalytical regulations Stimulate best practices, considering science and regulations 48

6 What is still in front of us? Full consensus amongst regulators on a number of ambiguities. One harmonized Guidance on Bioanalysis? 49

7 Applicable Guidance FDA-2013?? FDA-2013?? SFDA? Open Letter to the regulators Defining mission, vision, teams and Preparing execution of agreed (i.e. publication, global meeting,..) and intense communication at global meetings Understanding impact of delayed release of draft FDA guidance and adapt Prepare next steps of GBC today 50

8 And now FDA-2013?? FDA-2013?? SFDA? Open Letter to the regulators Defining mission, vision, teams and Preparing execution of agreed (i.e. publication, global meeting,..) and intense communication at global meetings Understanding impact of delayed release of draft FDA guidance and adapt Prepare next steps of GBC today 51

9 Building a global community GBC and the regions: Bring more ownership of discussions to regions Acknowledge that regional organizations are closer to the scientists and can connect better to the regional regulators. Regional organizations can become or continue to be: First point of contact for (regional) regulators Interface between bioanalytical community and other (regional) communities (e.g. QA, PK, toxicology, pharmacology) Can GBC grow to become glue between regional BA organizations, and if so, what is needed? 52

10 And what about harmonization? With many guidelines showing differences and ambiguities should we replace by a harmonized ICH guideline? GBC-SC is currently considering potential consequences of promoting an ICH guideline. Highlights are: Realistic aspiration, i.e.: Harmonize regional differences; propose best global practices Clarifications on ambiguities Clarify the scope of regulations (e.g. when is a validated assay required and when can other criteria be applied) Be aware ICH does not represent all regions/countries, but also that ICH Guidance is often used as a point of reference in industry and by RA in non-ich countries Encourage strong discussion in BA community prior to stepping to ICH If harmonization is supported by GBC: liaise with ICH parties to bring a proposal to the ICH Steering Committee 53