Continuing Medical Education (CME) in Germany

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1.
 
Early Access Programmes & Compassionate Use in the EU
ID
854514
Start date
20 Feb 2017
Location
Düsseldorf, Meliá Düsseldorf, Germany
Abstract
This seminar provides you with a detailed overview of early access possibilities in the EU in general as well as in Germany, the UK, Spain and France in particular. After having attended the seminar, you will be aware of the available options for, and the arising challenges of, bringing your pharmaceuticals to the European market as fast as possible. Specifically, topics such as eligibility to the various programmes, data requirements and reimbursement options will be discussed in order to acquire a deep understanding of how patients could benefit from your products at the earliest possible.
Contact
Dr. Henriette Wolf-Klein;     Phone: [+49 6221 500-680];     Email: h.wolf-klein@forum-institut.de
Topics
medical affairs, market access, healthcare management, early access in the EU legal framework, compassionate use in France - ATU as best practice?, early access in the UK - the early access to medicines scheme, early access possibilities in Spain, the German compassionate use programme - lessons learnt
2.
 
GMP inspections in Russia, Belarus and Kazakhstan
ID
854578
Start date
22 Feb 2017
Location
Berlin, Mercure Hotel MOA Berlin, Germany
Abstract
Local authorities inspect the production of drug products in Russia, Belarus and Kazakhstan. This seminar will provide you with in-depth knowledge on current requirements for GMP inspections in these countries. After having attended this seminar you will be aware of current guidelines and the legal basis for GMP in Russia and further CIS countries. You will be able to prepare for and pass Russian GMP inspections, and you will know what Russian GMP inspectors expect. In addition, you will examine first hand experience of GMP inspections in production sites outside of Russia and you will be made familiar with future plans for GMP inspections by Russian health authorities.
Contact
Dr. Henriette Wolf-Klein;     Phone: [+49 6221 500-680];     Email: h.wolf-klein@forum-institut.de
Topics
quality management, regulatory affairs, vigilance, legal basis for GMP in Russia and further CIS countries, procedure of drug product registration in Russia, Belarus and Kazakhstan, GMP inspections within Russia: Expectations and procedures, GMP inspections of production sites outside of Russia, TO DO: Plans for GMP inspections by Russian health authorities
3.
 
CMC Documentation & Post-Approval Changes/Variations
ID
854554
Dates
22 Mar 2017 - 23 Mar 2017
Location
Frankfurt, NH Frankfurt Niederrad, Germany
Abstract
Do you work in regulatory affairs/CMC or quality assurance? Then you shouldn’t miss out on this event. This conference will address very practical questions and provide strategic information on future CMC trends. Join the in-depth discussion on new developments, including: requirements for drug substance and drug product, elemental impurities and stability, ASMF worksharing, GMP inspection and QP declaration, quality documentation of IMPs, quality risk management, management of post-approval CMC changes and much more.
Contact
Laura Vogelmann;     Phone: [+49 6221 500-655];     Email: l.vogelmann@forum-institut.de
Topics
quality management, regulatory affairs, vigilance, drug substance and drug product in Module 3, how to implement ICH Q3D?, ASMF worksharing, QP declaration and GMP inspection, post-approval change management, CMC part of the IMPD

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Last updated: 06 December 2016