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.
Attend one of our free pre-meetings to familiarise yourself with the Learning Space and the various ways in which you can interact during the event
- Combination of three compulsory seminars plus one elective module for (future) Heads of the Pharmacovigilance Department - Learn the responsibilities and legal aspects of managing a PV system and its staff, and select an elective module according to your individual interests.
- Combination of three selected seminars - With this qualification course, you will first gain insight into the legal aspects and general responsibilities of the Qualified Person for Pharmacovigilance (QPPV). You will then deepen your professional and practical knowledge to perform your role more effectively.
With this qualification course, you can continue your education in a structured manner in all CMC topics, with a technical focus on development methods, manufacturing processes, CMC documents, change management, and much more.
This e-Learning programme will provide you with knowledge on Good Distribution Practice in today's pharmaceutical industry
Experts from national authorities speak about the current developments with regard to e.g. the revision of guidelines (GACP, Variation Regulation, Variation Classification Guideline (current status)), the changes of procedures and corresponding chances (MRP/DCP), and the use/"impact" of new evaluation methods (Real World Data). The authority prespective is complemented by industry experience.
Our e-learning, specially tailored for medical device advisors, provides you with the essential knowledge to navigate your professional duties confidently and in full legal compliance.
Our e-learning, specially tailored for medical device advisors, provides you with the essential knowledge to navigate your professional duties confidently and in full legal compliance.
Gain essential knowledge for your entry into the medical device industry in just 90 minutes! Understand regulations, market access, and vigilance with our compact e-learning.
CMC requirements in Latin America with focus Mexico, Brazil, Colombia, Argentina, Chile, and Peru. The seminar (2 half days) is comfortable to integrate into your daily work routine.
This seminar explores how artificial intelligence can be effectively and responsibly integrated into regulatory writing processes. You'll gain insights into legal requirements, learn about AI tools and technologies, and see how they apply to CTD documentation through practical examples and a live demonstration.
