Helmut
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Vienna, Austria,
2022-12-10 10:43
(57 d 17:47 ago)

Posting: # 23396
Views: 990
 

 Medicines for Europe: 2nd BE Work­shop [Conferences / Workshops]

Dear all,

Medicines for Europe is organizing its 2nd Bioequi­va­lence Work­shop on April 26th, 2023 in Brussels. The program is still being developed but is expected to cover:
  • International convergence and reliance
  • ICH M13*
  • Model informed drug development and virtual BE
  • Implementation of M10 from the European perspective
  • Compliance and oversight in BE
It would be extremely valuable to have your participation and views in these very exciting times for bioequivalence. Further details will be provided in January.


  • Step 2a/2b endorsement of the first draft guideline in the series (M13A focusing on BE study considerations of IR formulations and data ana­ly­sis for a non-replicate study design); start of public consultation planned for December 2022.

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ElMaestro
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Denmark,
2022-12-10 15:48
(57 d 12:41 ago)

@ Helmut
Posting: # 23400
Views: 865
 

 Medicines for Europe: 2nd BE Work­shop

Hi,

"ensuring the highest levels of quality, safety and efficacy is the highest priority for our members"

...and that is why I hope they will seriously put fraud and data integrity on the agenda. It is apparently a topic no-one wants to discuss in much detail.

But allow me an opinion: It will not go away just because we don't talk about it. On the contrary I think we need to admit more broadly it happens before it will start to fade.

Pass or fail!
ElMaestro
SMA
☆    

Europe,
2023-01-18 10:48
(18 d 17:41 ago)

@ Helmut
Posting: # 23428
Views: 249
 

 Medicines for Europe: 2nd BE Work­shop

Dear all

Medicines for Europe is organizing its 2nd Bioequi­va­lence Work­shop[/link] on April 26th, 2023 in Brussels. The program is still being developed


Program has been posted and registration is open.
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