25th Global GMP & Regulatory API Conference from 26 – 27 October

APIC/CEFIC in cooperation with Concept Heidelberg have organized the Global GMP & Regulatory API Conference for the 25th time. This year’s event from 26 – 27 October 2022 was conducted for the first time as a Hybrid Conference - on-site in Amsterdam and streamed live online.

The event with more than 20 speakers from authorities and industry received an outstanding rating by the participants from more than 25 countries. Authority representatives included:

  • Lawrence Yu, US FDA, USA
  • Rapti Madurawe, US FDA, USA
  • Stelios Tsinontides, US FDA, USA
  • Hélène Bruguera, EDQM, France
  • Brendan Cuddy, EMA, The Netherlands
  • Robert Bream, EMA, The Netherlands

Lawrence Yu gave an overview about ICH M4Q(R2) and FDA’s KASA Initiative. He described the Cloud-based Regulatory Assessment and visualized the needs to transform the Regulatory Assessment and Submission into the cloud.

Rapti Madurawe, US FDA, USA, provided a regulator’s perspective on the topic Q13 and the advancement on Continuous Manufacturing (CM). She summarized the latest activities and timelines and pointed out the discussion topics split off to GMP elements, illustrative examples, CM concepts and control strategy.

Stelios Tsinontides, US FDA, USA, presented FDA’s approaches to Facility Pre-Approval/Pre-License inspections during the COVID-19 pandemic. He explained the impact of the COVID-19 pandemic and emphasized the measurements of the FDA like “Remote Interactive Evaluations (RIE)“.

Hélène Bruguera from EDQM, France, has been a speaker for many years. Her presentations about the latest developments at EDQM always receive highest interest by the participants. She informed about the updates of the European Pharmacopoeia (Ph. Eur.), EDQM’s activities with regard to the CEP procedure and EDQM’s international co-operation with other authorities.

Brendan Cuddy from EMA, The Netherlands, provided an overview about EMA’s activities and highlighted the four most important priorities „modernise GMP and facilitate innovation“, „support inspection capacity“, „inspection reliance and new approaches to verify compliance“ and „international collaboration and harmonisation“.

Robert Bream, EMA, The Netherlands presented in his parallel session the latest developments regarding nitrosamine impurities and pointed out the facts and figures learnt from the EMA’s call for review.                                        

Further speakers from industry informed about hot GMP and regulatory topics with regard to APIs – such as the sustainability initiatives and their impact on the API industry, practical experiences with the Brazilian CADIFA, cloud computing in the API industry and regulatory hurdles and opportunities. Furthermore, topics such as challenges with API registration in China, ICH Q12 implementation in practice and many more received high attention.

SAVE THE DATE! The 26th Global GMP & Regulatory API Conference will take place from 25 - 26 October 2023 in Berlin. Also, this year, the conference will be complemented by a Pre-Conference Session (on 24th of October 2023) and will be once again conducted as a hybrid event – on-site in Berlin and online! High-ranking representatives from international drug authorities and industry will report on current developments in the quality and approval of APIs in Europe and non-European countries.


Here are some pictures taken at the Conference. Click on the pictures to enlarge them: