Author: Dr Alexander Natz, LL.M.
On 26 April 2023, the draft of the EU Pharmaceutical Legislation was published.
This white paper addresses the new concept of the legislation, which will also include the Orphan Medicines Regulation and the Paediatric Regulation.
The roadmap for implementation is addressed here - although this will be somewhat interrupted by the EU parliamentary elections next year. Two major points of the legislation will be the concept of 'unmet medical need' and the modified Regulatory Data Protection Schemes. Overall, the legislation is expected to have a high impact on drug development and marketing in Europe.
Download now the white paper 'EU Pharmaceutical Legislation – The most important changes at a glance'.
We hope you enjoy reading it!
Mit diesem flexiblen Qualifikationslehrgang erlangen Sie innerhalb von 12 Monaten ein grundlegendes Verständnis des rechtlichen/regulatorischen Umfeldes in der Pharmaindustrie.
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
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 this qualification course, you can continue your education in a structured manner in all global regulatory affairs topics, with a regional or country-specific focus.
This online conference addresses the digitalisation of labelling, the transformational potential of emerging technologies like AI and how pharma companies need to prepare to implement these technologies in the regulaory affairs context.
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!
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This online training will give you in-depth knowledge on the CMC requirements for marketing authorisation. Take the chance to participate in our virtual seminar and get qualified.
Are you new to pharmacovigilance and looking to kick-start your career? Then this online course is just for you. Gain a comprehensive overview of pharmacovigilance, regulatory requirements in the EU and implementation in only two days. Book now!
Development of inhaler/inhalants/pulmonal drugs: An overview of the regulatory/quality (CMC), device and clinical requirements - what is relevant for approval? what's "new"? Four proven experts will discuss all relevant aspects with you and your colleagues from the industry.
Do you want to independently plan and conduct pharmacovigilance audits? Then take this opportunity to become an "Auditor for Good Pharmacovigilance Practices". Secure your place on our compact, interactive online course. Book now!
