12 December 2017 EMA/779846/2017 International Affairs
2nd International Awareness Session - The EU medicines regulatory system and the European Medicines Agency An introduction for international regulators, NGOs and academia 08-09 March 2018 London, UK Chair: Dr Agnès Saint-Raymond
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2nd International Awareness Session - European Medicines Agency
Dec 12, 2017 - Medicines Agency. EMA/779846/2017. Page 2/3. Day 1 - Thursday 8 March 2018. Time. Module / Topics. 08:45-. 09:00. Opening remarks and Official welcome. 09:00-. 10:00. 01 - Setting the scene: Introduction to the EU Regulatory. Network (including committees). â¢ The EU and the EU Regulatory Network.
Apr 28, 2017 - 2. The United Kingdom will then become a 'third country'. 3. Preparing for the withdrawal is therefore not just a matter for EU and national authorities, but also for private parties. In view of the considerable uncertainties, in parti
May 30, 2017 - Pharmaceutical companies are invited to present their pre-clinical data pertaining to ... patients per year, as many questions about the best use of ALK ... of knowledge and evidence to support the planning and regulatory.
Mar 8, 2018 - Treatment of uterine fibroids. Haematology. New medicines authorised. â¢ Adynovi (rurioctocog alfa pegol). Treatment and prevention of bleeding in patients with haemophilia A. New information on authorised medicines. â¢ Feraccru (ferr
The new EudraVigilance system and the electronic reporting of individual case ... the ISO/ICH E2B(R3) format: hands-on training course - October 2017 ... granted a conditional marketing authorisation on the basis of less complete clinical data ...
On arriving for your meeting at 30 Churchill Place, please report to reception where you will be issued with an access pass. This pass will allow you to enter our industry lounge, which you are welcome to utilise during your visit. The industry loung
RSS feeds you need one of the following: a modern web browser; a web-based news reader or a ... Withdrawal of applications for new medicines .... fifth annual regulatory conference on optimising the development of advanced therapies to.
Jun 18, 2018 - 27. 7.8.1. List of all applications submitted/expected and the COMP coordinatorship distribution of .... 5,10-dihydrodibenzo[b,e][1,4] diazepin-11-one, EMA/OD/031/10 Glutathione-pegylated ...... Abbreviations / Acronyms.
European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged. 13 September 2017. EMA/727763/2017. Human Medicines Evaluation Division. List of nationally authorised medicinal products. Active substance(s): dexlansop