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.
- 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.
With our modular qualification course, you can expand your competencies in drug regulatory affairs in a targeted and practice-oriented manner. You design your learning pathway individually and set professional focus areas in line with your occupational requirements. Including an overall certificate and up to 30% price advantage compared with individual bookings.
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.
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.
Global variations and lifecycle management - covering key regions: USA, Asia (China, Japan, South Korea), LATAM (Central America, Brazil), and Gulf Cooperation Council (GCC). Take this opportunity to discuss your specific daily business challenges with our experts and network with peers to see how others approach similar issues!
Do you already have a good understanding of PSUR and RMP including risk minimisation measures and would like to deepen, broaden and update your knowledge? In this course, you will enhance your practical skills in preparing, assessing, and managing RMPs and PSURs, and learn about the latest requirements of GVP Module XVI (Rev. 3) and the new Implementing Regulation (EU) 2025/1466.
