23rd Global GMP & Regulatory API Conference from 28 – 30 October

APIC/CEFIC in cooperation with Concept Heidelberg have organised the Global GMP & Regulatory API Conference for the 23rd time. This year’s event from 28 – 30 October was conducted live online for the first time.

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

  • Dr Sau (Larry) Lee, US FDA, USA
  • Dr Robert Bream, EMA, The Netherlands
  • Hélène Bruguera, EDQM France
  • Ibrahim H. Mujammami, SFDA, Saudi Arabia
  • Rosimeire Pereira Alves da Cruz, ANVISA, Brazil

Dr Sau (Larry Lee) gave an overview about Innovation and continuous manufacturing from the US FDA’s point of view. He described FDA’s efforts to modernize drug manufacturing and highlighted the different approaches for batch vs. continuous manufacturing. In addition he informed about the activities of the FDA’s Emerging Technology Program.

Dr Robert Bream provided an European Medicines Agency (EMA) view on the latest developments and lessons learnt in nitrosamine impurities. He summarized the root causes for nitrosamine impurities identified so far and the outcome of the different referrals. He gave an overview about the implementation plan and regulatory expectations from the call for review and a summary of the lessons learned exercise document.

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 on the certification scheme, the EDQM Inspection programme and regarding Nitrosamine Impurities actions taken by the EDQM.

For the first time in the long history of the conference a speaker from Saudi Arabia FDA agreed to speak about the registration procedures for APIs in the Gulf States. He gave an overview about the regulatory framework, the registration procedures of APIs and the international collaborations of Saudi Arabia FDA.

Rosimeire Pereira Alves da Cruz from ANVISA, Brazil, has been a speaker of the conference in the past. Because of the high interest in ANVISA regulations and interpretations she also joined this year´s event as a speaker. She gave an overview about ANVISA´s current view on inspections. In addition to the status and review of ANVISA´s inspection activities she also provided an update on the Top 10 findings from the agency inspections.

Further speakers from industry informed about hot GMP and Regulatory topics with regard to APIs such as API Fillings in South Korea, China and Brazil. Furthermore, topics such as Cleaning in multipurpose facilities, ICH Q12/Q13 and many more received high attention.

The next Conference will be held from 26 – 28 October 2021 with new GMP and Regulatory topics regarding APIs.


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