Press Releases from FORUM Institute of Management (8 total)
Step by step through Medical Device Law
Which laws apply to a clinical trial by medical devices? Which forms of advertising are permitted? Under which circumstances is the manufacturer liable? And when…
Quality Documentation of Medicinal Substances incorporated in Medical Devices
In order to demonstrate appropriate quality for incorporated medicinal substances in medical devices (ancillary medicinal substances), applicants need to provide information and scientific data, which…
The safety inspector for medical device
Every medical device company had to reappoint somebody to the safety inspector of medical devices. This positon comprised a great accountability with personal liability…
Advanced Therapies - Marketing Authorisation of ATMPs - Tasks for CAT
For the first time, all "advanced therapies" (gene therapy, somatic cell therapy and tissue engineering products) will be centralised in a single procedure of the…
Marketing Authorisation in Europe 2009
2007/2008 have brought many changes in the field of regulatory affairs. 2009 casts its shadow ahead.
- What kind of changes does the revision of the…
Marketing Authorisation in the Middle East - Algeria, Egypt, Jordan, Saudi Arabi …
The countries of the Middle East are sometimes underestimated as attractive markets for pharmaceuticals. A thorough knowledge of the local marketing authorisation systems is essential…
Directive 2004/27/EC - status of the national implementation in Europe
The Directive 2004/27/EC was adopted in 2004 and had to be implemented into national law by 30 October 2005.
- What does the national implementation look…
Protection of pharmaceutical innovation in Europe - Data exclusivity & Roche Bol …
FORUM Institute of Management organises an international conference on the new intellectual property rights after the implementation of the Directive 2004/27/EC.
Especially topics as the new…
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