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.
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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.
Combined offer 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.
This e-Learning programme will provide you with knowledge on Good Distribution Practice in today's pharmaceutical industry
Get your know-how on creating and maintaining quality data for biotech products in our online training. Including an outlook on the new (Draft) ICH Q1 and ICH M4Q(R2).
Our global and local experts will update you every two months with the latest regulatory and legislative developments. Thus, you will always have the essential information and trends in regulatory affairs at your fingertips!
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.
The most important decisions of the Boards of Appeal in the field of biopharmaceuticals and biotechnology and changes in the Guidelines will be presented. The panelists will discuss, in particular, the consequences of these decisions and changes on patent practice.
