24th Global GMP & Regulatory API Conference from 26 – 28 October

APIC/CEFIC in cooperation with Concept Heidelberg have organized the Global GMP & Regulatory API Conference for the 24th time. The event from 26 – 28 October 2021 was once again conducted as a Live Online Conference.

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:

  • Lyle Canida, US FDA, USA
  • Hélène Bruguera, EDQM, France
  • Rita Purcell, HPRA, Ireland
  • Renan Araujo Gois, ANVISA, Brazil
  • Andrzej Rys, European Commission, Belgium

Lyle Canida gave an overview about FDA’s Quality Management Maturity (QMM) Program. He described the Pilot Program and highlighted FDA’s efforts to provide incentives to the Pharmaceutical Industry to establish and move forward to a higher QMM.

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 API inspections – remote and onsite - and EDQM’s view on the CEP of the future.

Rita Purcell, HPRA, Ireland, provided a European Regulator’s perspective on the topic Brexit. She summarized the latest activities and timelines and pointed out the impact of Brexit on medicines regulation.

Renan Araujo Gois from ANVISA, Brazil, newly joined the speakers’ team of the conference in 2021. He gave an overview about the Regulatory System in Brazil and highlighted the facts and figures about the DIFA (Active Pharmaceutical Ingredient Dossier) and the CADIFA (Letter of Suitability of the Active Pharmaceutical Ingredient). In addition, he summarized the most common and frequently asked questions related to the API registration process.

Andrzej Rys of the European Commission in Belgium presented the EU position on reshoring of APIs. He explained the impact of the COVID-19 pandemic and emphasized that the security of the supply is of high political priority. Additionally, he provided an overview about the vulnerabilities like dependencies and regulatory challenges.

Further speakers from industry informed about hot GMP and Regulatory topics with regard to APIs – such as the complexity of global API supply chains, the importance of workplace wellbeing and the digitalization opportunities in API development. Furthermore, topics such as updates on EAEU legislation, latest developments in nitrosamine impurities and many more received high attention.

SAVE THE DATE! The 25th Global GMP & Regulatory API Conference will take place from 26 - 27 October 2022 in Amsterdam. This year the conference will be complemented by a Pre-Conference Session (on 25th of October 2022) and will be conducted as a hybrid event – onsite 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: