30 Years of APIC - Highlights of the "25. APIC/CEFIC Global GMP & Regulatory API Conference"


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For manufacturers of active pharmaceutical ingredients as well as the pharmaceutical industry, the APIC's annual API Conference is the most important forum. In 2022, the "25th APIC / CEFIC Global GMP & Regulatory API Conference" was held as a hybrid conference for the first time - in Amsterdam and online. Thus, in the anniversary year of APIC, which celebrated its 30th anniversary in 2022, participants and speakers from the API industry and international authorities were once again able to exchange information on current developments on-site. The increased focus on global collaboration, sustainability and common challenges in the field of regulatory affairs and GMP-compliant manufacturing were reflected in the selection of speakers.

After the opening of the conference by APIC President Hilde Vanneste, one of APIC's representatives, Marieke van Dalen, guided the participants and speakers on-site in Amsterdam and online through the morning of the first conference day.

The first presentation was given by Brendan Cuddy, EMA, who gave an update on EMA activities and divided it into two main topics. These included updates on the activities of the Good Manufacturing and Distribution Practices Inspector Working Group (GMDP IWG) and on what is known as CMC Innovation. The first topic was again divided into three sections, which showed the highlights of 2021 and 2022, the newly published guidelines such as the new Annex 1 & Annex 21 and the new veterinary regulations as well as conclusions from the pandemic years. As shown in Figure 1, the four main strategic priorities were "Modernise GMP and facilitate innovation", "Support inspection capacity", "Inspection reliance and new approaches to verify compliance" and "International collaboration and harmonisation".

Also on the morning of the first day of the conference, Dirkjan van Zoelen, Aspen Oss B.V., spoke about the impact of sustainability initiatives in the API industry in his presentation "Sustainability Initiatives: Impact on API industry", and Matt Moran, Ibec, highlighted the history of the committee and the emergence of the APIC Conference on the occasion of the 30th anniversary of APIC.

The questions and comments of the participants on-site and online were always answered and discussed after each presentation, so that a direct exchange on each subject area was always ensured.

After the lunch break, the participants of the "25th APIC/CEFIC Global GMP & Regulatory API Conference" were able to attend the first four Parallel Sessions online and on-site, which were led by APIC representative Rainer Fendt and representative Graca Mata, and selected from GMP and regulatory topics. These included the presentations "Practical Experience with the Brazilian CADIFA," "Risk-based Approach during Supplier Qualification and Management," "How to assure Successful Investigations and CAPAs," and "Information Sharing between the API Manufacturer and the Drug Product Manufacturer."

The closing lecture "Keep up-to-date with EDQM work" of the first conference day was given by Hélène Bruguera, EDQM, who presented the activities and innovations around the CEP procedure and the international cooperation of EDQM with other organizations.

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The second day of the conference started with six practice-oriented Parallel Sessions, which again offered a diverse range of topics. Depending on their areas of interest, participants online and on-site could choose after each session which of the thematic blocks from the GMP and regulatory field they would attend next. The presentations "Cloud Computing in the API Industry", "Latest Developments in Nitrosamines - What have we learned from EMA's Call for Review?" and "Auditing Manufacturers of Regulatory Starting Materials" as well as the presentations "Challenges with API Registrations in China", "Regulatory Hurdles and Opportunities" and "ICH Q12 Implementation in Practice" were lively discussed.

After the lunch break, Mario Hellings, Janssen Pharmaceutica, presented "ICH Q2/Q14 - Analytical Procedures - Development and Validation" on the validation of analytical methods and the relationship between the ICH Q2 and ICH Q14 guidelines.

Particular attention was probably paid to the contributions of the three U.S. FDA speakers, some of whom joined the conference online, some on-site in Amsterdam. In addition to the presentations by Rapti Madurawe, US FDA, on "Q13 and Continuous Manufacturing Advancement" and Lawrence Yu, US FDA, on "Cloud-based Regulatory Assessment: ICH M4Q(R2) and FDA KASA Initiative", Stelios Tsinontides, US FDA, gave his presentation on "FDA Approaches to Facility Pre-Approval/Pre-License Inspections during the COVID-19 Pandemic and Beyond" (see also Figure 2). Herein, he described the US FDA's approaches and initiatives to "...ensure safe, effective, and high-quality medicines for the American people...". Using the corona pandemic as an example, the challenges and opportunities associated with this were presented and explained. For example, the so-called "Remote Interactive Evaluations (RIE)" emerged, which are applied to evaluate the general cGxP compliance of a company and can be seen as preparation for an inspection.

Figure 1: Slide 7 of presentation „Update from EMA“ by Brendan Cuddy, EMA

Figure 2: Slide 5 of presentation „FDA Approaches to Facility Pre-Approval/Pre-License Inspections during the COVID-19 Pandemic and Beyond” by Stelios Tsinontides, US FDA

Following the final Q&A session, Hilde Vanneste concluded the "25th APIC / CEFIC Global GMP & Regulatory API Conference" with her closing remarks.

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This year, the exchange between representatives of industry and authorities once again formed the core of this conference. The dedicated Q&A sessions of the event provided a perfect framework for this. 

Note: Th e "26th APIC / CEFIC Global GMP & Regulatory API Conference" will take place in Berlin on October 25-26, 2023. High-ranking representatives from international drug regulatory authorities and industry will report on the current quality and regulatory trends in active pharmaceutical ingredients and discuss current issues with you. Like last year, we will hold a hybrid conference so you can choose how you want to participate - online or on-site.


About the Author
Anne Günster
... joined CONCEPT HEIDELBERG in 2019 and organises and conducts courses and conferences on behalf of the ECA Academy in the areas API Manufacturing, Regulatory Affairs, Documentation and Laboratory Data Integrity.

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