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[UK] MHRA: Drug Safety Update: Volume 4, Issue 1, August 2010The August issue of Drug Safety Update includes drug safety advice for the protease inhibitor saquinavir (effects on cardiac conduction), and for calcium gluconate in small-volume glass containers (risk of aluminium exposure in vulnerable patients). [EU] EMA: European Medicines Agency scientific debate, ICPE, Brighton, From: 20-Aug-2010, To: 20-Aug-2010The European Medicines Agency is organising a public debate on the use of epidemiology in the assessment of drug effects at the International Conference on Pharmacoepidemiology & Therapeutic Risk Management congress in Brighton on 20 August 2010. The debate will be moderated by Hans-Georg Eichler, the Agency's Senior Medical Officer. The Executive Director of the European Medicines Agency, Thomas Lönngren, will deliver the keynote address at ICPE on the same day. Participation is free to attendees of the ICPE congress. [CH] Swissmedic: Information sheet relating to the form Confirmation regarding substances from genetically modified organismsThe new information sheet: Confirmation regarding substances from genetically modified organisms (GMO) explains the legal basis for the form of the same name that came into force on 1 April, and how to use it correctly. It will also provide clarification on various points concerning its use in practice, and on which stakeholders have been uncertain about how to proceed. [CH] Swissmedic: Revision of the form Confirmation regarding substances from GMO in terms of wordingThe wording in the form Confirmation of substances from GMOs has been slightly revised with a view to being more easily understood. The requirements concerned, regarding mandatory declaration, nevertheless remain unchanged. [EU] MHA: UPDATE - Public AR for paediatric studies submitted in accordance with Article 46 of Regulation No 1901/2006, as amendedUPDATE - Public AR for paediatric studies submitted in accordance with Article 46 of Regulation No 1901/2006, as amended, http://www.hma.eu/193.html [EU] HMA: UPDATE - Public AR for paediatric studies submitted in accordance with Article 45 of Regulation No 1901/2006, as amendedUPDATE - Public AR for paediatric studies submitted in accordance with Article 45 of Regulation No 1901/2006, as amended, http://www.hma.eu/193.html [EU] HMA: NEW - Template on Validation for Application on Marketing Authorisation CMDh: document addedNEW - Template on Validation for Application on Marketing Authorisation CMDh: document added, http://www.hma.eu/219.html |
These European updates are some of the recent key regulatory news items we have noted, including those from the regulatory agencies and authorities in Europe. A two-letter code is used at the beginning of each item to indicate the country or region, according to the