Press Releases from FORUM Institute of Management (8 total)

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 is the user? The current 4th amendment of the German Medical Device Act (MPG) and the associated new requirements for manufacturers. FORUM Institut für Management extend to this tender subject an intensive seminar. The attendant limiting allows great deal of discussions. FORUM Institute fuer Management,…

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 are similar to that requested by authorithies for API"s in medicinal products. These data are submitted to the competent authorities by the notified body involved. FORUM Institut für Management extend to this tender subject an intensive seminar. The attendant limiting allows great deal of…

Every medical device company had to reappoint somebody to the safety inspector of medical devices. This positon comprised a great accountability with personal liability in the field of the company and also to the user. The safety inspector for medical device is bound to procedural requirements. The postion proceed an important role in the risk management. Das FORUM Institut für Management extend to this tender subject an…

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 newly adopted European Regulation No 1394/2007 ("the Regulation") on advanced therapy medicinal products (ATMPs). This regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of ATMPs and will apply as of 30 December 2008. The focus of this seminar will be on the required legitimate…

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 EU guidance on the SmPC bring? - What is the current status of the new variation regulation? - The paperless eCTD - is it a reality coming soon? - Sunset clause - are all questions answered? FORUM Institute fuer Management, one of the leading professional seminar and conference providers…

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 in order to successfully get a foothold in these markets. FORUM Institute fuer Management, one of the leading professional seminar and conference providers in Europe, offers a seminar for the pharmaceutical industry on 17 September 2008 in Munich. Further information on the seminar and the…

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 like right now? - What is the actual regulatory framework in Germany, France, Poland, The Netherlands and Sweden? FORUM Institute of Management organises an international conference addressing among others these questions. Seven European experts will discuss the essential topics of the Directive 2004/27/EC and thus, inform on the current…

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 data exclusivity scheme and the implementation of Roche Bolar will be addressed by: Ian Dodds-Smith, Arnold & Porter LLP, London; Dr. John Lisman, Medicines Evaluation Board, Den Haag; Dorthe Poulsen, The Danish Medicines Agency, København; Burkhard Sträter, law firm Sträter, Bonn For further information please check http://www.forum-institut.de/sites/veranstaltung.asp?SemNr=0605238 or contact Dr. Henriette Wolf-Klein Deputy…