Chemically Synthetized APIs MasterClass - EU edition

This MasterClass will provide an overview on GMP as well as CTD requirements related to small molecule APIs.

03-05 March, 2026, Virtual

Time Zone : UTC/GMT+1 /CET

Overview

Most drug product manufacturers do not synthetize APIs in commercial quantities in their own facilities. They purchase it from external sources. It is equally important for API manufacturers and drug product producers to understand the regulatory requirements in the EU to be prepared for submission of ASMFs /CEPs and marketing authorisation applications. The challenge today is, to deal with the transition from current guidelines to new and revised regulatory requirements.

One major revision is the fundamental re-organisation of the quality documents in the CTD structure as described in the draft ICH M4Q(R2). To compile the marketing authorisation dossier, detailed information on synthesis development and the commercial manufacturing process of an API are required. There is a conflict of interest between the detailed information required by the regulatory authorities and the API manufacturers who need to protect their proprietary know how. This conflict can be solved by using the European ASMF or CEP procedures.

Drug product manufacturers should be aware of the limitations of both procedures, however. They have to be prepared to request essential GMP and CMC documents from the API manufacturer.to assume full responsibility for all quality and safety aspects of their drug product. Due to global supply chains, specific challenges with respect to import regulations and global communication will have to be taken into account, too.

This MasterClass will provide an overview on GMP as well as CTD requirements related to small molecule APIs.

New ASMF procedures sketched in the draft revision of EU Directives and planned revision of EMA and ICH guidelines will be presented.

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WHO SHOULD ATTEND

-Heads of R&D
-Heads of API development
-Heads of QC
-QA Heads
-Heads of drug regulatory affairs
-CMC specialists
-Pharmaceutical development managers
-API synthesis chemists
-Regulatory affairs managers
-Stability control managers
-QC and QA managers