Regulatory Affairs
Enhance your expertise in Regulatory Affairs. Our training courses on medicinal product approval, including CTD, CMC, eSubmission, and MRP and DCP procedures, as well as maintenance topics such as variations, prepare you for marketing authorisation and lifecycle management responsibilities.
Repurposed drugs - Access to the European Market
This online seminar equips regulatory affairs, IP, legal and market access professionals with practical strategies to navigate the complex journey from drug repurposing to European market…Language: English
Market Access of Biosimilars in Europe
Biosimilar uptake in Europe, Aut idem in Germany - these are the challenges for regulatory affairs and market accessLanguage: English
Radiopharmaceuticals: A practical CMC and quality perspective
Radiopharmaceuticals are facing a pivotal regulatory moment. This seminar brings together experts from a regulatory authority, a CDMO, and a sponsoring company to provide practical, up-to-date…Language: English
APIs in the dossier: Quality data, e-submission, global regulatory strategy
Are you a professional responsible for preparing quality documentation for active pharmaceutical ingredients (APIs) and their starting materials in the field of market authorisation? Then this is the…Language: English
Quality & GMP Essentials for Regulatory Affairs/CMC
Quality & GMP Essentials for Regulatory Affairs/CMC: Managing the interface - knowledge of quality-relevant facts, GMP fundamentals, as well as understanding of the processes at the interface -…Language: English
ExpertFORUM Global Regulatory Affairs
This online conference offers compact expert talks and diverse perspectives on global regulatory strategies, digital transformation and evidence generation. Expect focused insights, practical…Language: English
CMC dossier requirements: FDA vs EU
CMC dossier requirements FDA vs EU: After having attended the seminar you will feel secure writing and maintaining the quality dossier for US marketing authorisations of small and large molecules…Language: English
Contact
We are happy to provide you with personal and individual advice.
Our professional development portfolio is extensive. We would be pleased to discuss your requirements with you personally and help identify the most suitable options from our range of offerings. Let our professional development experts advise you and feel free to contact us today.
Jean-Marie Bayhurst
Conference Manager Pharma & Healthcare
+49 6221 500-685
j.bayhurst@forum-institut.de