Focus: EU and ICH Requirements
Author: Dr Helmut Vigenschow
Navigate the latest stability testing topics related to drug products with this comprehensive overview on the regulatory requirements during product development and lifecycle. This includes aspects covered by the new draft ICH Q1 guideline. This resource clarifies regulatory expectations for marketing authorisation applications, covering essential topics like accelerated testing conditions, shelf-life determination, climatic zone requirements, and stability commitments. Understand how to design compliant studies, interpret results, and prepare CTD documentation effectively. A practical reference for pharmaceutical professionals seeking current guidance to support regulatory submissions and ensure compliance.
Download now the white paper 'Stability Testing of Drug Products – Focus: EU and ICH Requirements'.
We wish you many valuable insights as you read.
- Modular training programme consisting of three selected seminars and one elective module for Heads of Pharmacovigilance - Learn the responsibilities and legal aspects of managing a PV system and its staff, and select an elective module according to your individual interests.
- Modular training programme consisting of three selected seminars for Qualified Persons for Pharmacovigilance - Gain insight into the legal framework and core responsibilities of the Qualified Person for Pharmacovigilance (QPPV), then deepen your professional and practical knowledge to perform your role more effectively.
This e-Learning programme will provide you with knowledge on Good Distribution Practice in today's pharmaceutical industry
Stay informed with updates from our global and local experts, who will provide the latest regulatory and legislative insights every two months. In 2026, topics will include CMC documentation, regulatory intelligence, regulatory pathways in Africa, enrichment of PMS product data, global regulatory reliance models and ePI.
Regulatory expectations regarding risk management for pharmaceuticals in (emerging) markets often contend with the stringent standards set by the EU/ICH regions. Join us in six consecutive webcasts to gain insights into local pharmacovigilance systems in different countries and regions, and learn how to integrate them into your global PV system while maintaining a clear overview!
Join our interactive course to explore how AI is transforming pharmacovigilance. Take part in discussions, hands-on workshops, and case studies while diving into AI technologies, regulations, and their applications in drug safety. Register now to participate, share insights, and collaborate with peers!
This online training offers comprehensive insights into Regulatory Affairs, CMC, and GMP requirements, with a focus on the latest updates and developments in EAEU countries.
In this interactive two-day seminar, you will explore signal management best practices using PRAC case studies and learn how to effectively leverage digital tools such as EudraVigilance, programmable data analysis and AI. Complementary perspectives from both the marketing authorisation holder and the former authority provide valuable insights for your day-to-day work.
An interactive online seminar to explore real regulatory cases and challenges in marketing authorisation and lifecycle management across Mexico, Argentina, Colombia, Peru, Chile and Brazil - led by local experts from Brazil and Peru.
Biosimilar uptake in Europe, Aut idem in Germany - these are the challenges for regulatory affairs and market access
During our online training "Toxicology and beyond: Safety assessment in drug development" you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological data in the marketing authorisation dossier. Take the chance and participate in our interactive online training.
