Webinar on Product Information in the EU
December 17, 2015 - Fremont CA USNetzealous - Compliance4All
support@compliance4All.com
Phone:8004479407
Fax:302-288-6884
Overview: In order to obtain a marketing authorization, a Summary of Product Characteristics (SmPC) in accordance with Article 11 of Directive 2001/83/EC must be included in the application. In accordance with Directive 2001/83/EC, when the marketing authorization is issued, the Marketing Authorization Holder shall be informed, by the competent authorities of the Member States concerned, of the SmPC as approved by it. For decisions concerning centralized marketing authorizations, according to Article 10 of Regulation (EC) No 726/2004, the final Commission decision with the SmPC is addressed and notified to the Marketing Authorization Holder. Why should you Attend: Product Information consist of the Summary of Product Characteristics (SmPC), labelling text and package leaflet. The SmPC forms an intrinsic and integral part of the marketing authorization. It sets out the agreed position of the medicinal product as distilled during the course of the assessment process. As such the content cannot be changed except with the approval of the originating competent authority. SmPCs are a key part of the marketing authorization of all medicines authorized in the European Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively. They are kept updated throughout the lifecycle of a medicine as new efficacy or safety data emerge. The SmPC should be worded in clear and concise language. SmPCs are also the basis for the preparation of package leaflets, so are important documents in enabling information on medicines to reach patients. This webinar provides advice on the principles of presenting information in the SmPC. The text on the label and the package leaflet are usually the only items the patient will see from all documents included in a marketing authorization application, so it is very important that the texts are clear and of a high quality. Knowledge of how to write a package leaflet and which guidance documents are important is also vital to pass the so-called “user testing” which is mandatory before a medicinal product can be approved in the EU. Deviation from the guidelines should be justified in the Marketing Authorization Applications. This webinar provides an overview of the relevant guidance documents and practical advice of how to write the Product Information. Areas Covered in the Session: Important EU product information guidance documents for the SmPC Discussion of each section of the SmPC Guidelines on the packaging information and excipients Consultation with Target Patient Groups Who Will Benefit: Senior management Project Managers Medical writers CRAs and CRCs QA / Compliance personnel Investigators Clinical Research Scientists QA / QC Auditors and Staff Consultants Speaker Profile: Adriaan Fruijtier has graduated as a pharmacist at the University of Utrecht, The Netherlands. He is currently Director Regulatory Affairs at CATS Consultants. Until March 2004 he has been Head of the Oncology Group within Global Regulatory Affairs at Bayer AG, Wuppertal, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 and 2003 he was Director of Regulatory Affairs at Micromet AG, a biotech company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the European Medicines Agency in London, United Kingdom. Contact Detail: NetZealous - Compliance4All, 161 Mission Falls Lane, Suite 216, Fremont, CA 94539, USA. Phone: +1-800-447-9407 Email: support@compliance4All.com http://www.compliance4all.com/ Event Link : http://bit.ly/1WgYDMZ