BEGIN:VCALENDAR PRODID:NingEventWidget-v1 VERSION:2.0 METHOD:PUBLISH BEGIN:VTIMEZONE TZID:America/New_York X-LIC-LOCATION:America/New_York BEGIN:DAYLIGHT TZOFFSETFROM:-0500 TZOFFSETTO:-0400 TZNAME:EDT DTSTART:19700308T020000 RRULE:FREQ=YEARLY;BYMONTH=3;BYDAY=2SU END:DAYLIGHT BEGIN:STANDARD TZOFFSETFROM:-0400 TZOFFSETTO:-0500 TZNAME:EST DTSTART:19701101T020000 RRULE:FREQ=YEARLY;BYMONTH=11;BYDAY=1SU END:STANDARD END:VTIMEZONE BEGIN:VEVENT UID:2140535:Event:67083 DTSTAMP:20260524T131751Z SUMMARY:Webinar on Product Information in the EU DESCRIPTION:Overview: In order to obtain a marketing authorization, a Summary of Product Characteristics (SmPC) in accordance with Article 1 1 of Directive 2001/83/EC must be included in the application. In acco rdance with Directive 2001/83/EC, when the marketing authorization is issued, the Marketing Authorization Holder shall be informed, by the c ompetent authorities of the Member States concerned, of the SmPC as ap proved by it. For decisions concerning centralized marketing authoriza tions, according to Article 10 of Regulation (EC) No 726/2004, the fin al Commission decision with the SmPC is addressed and notified to the Marketing Authorization Holder.\nWhy should you Attend:\nProduct Infor mation consist of the Summary of Product Characteristics (SmPC), label ling text and package leaflet. The SmPC forms an intrinsic and integra l part of the marketing authorization. It sets out the agreed position of the medicinal product as distilled during the course of the assess ment process. As such the content cannot be changed except with the ap proval of the originating competent authority.\nSmPCs are a key part o f the marketing authorization of all medicines authorized in the Europ ean Union and the basis of information for healthcare professionals on how to use a medicine safely and effectively. They are kept updated t hroughout the lifecycle of a medicine as new efficacy or safety data e merge. The SmPC should be worded in clear and concise language. SmPCs are also the basis for the preparation of package leaflets, so are imp ortant documents in enabling information on medicines to reach patient s. This webinar provides advice on the principles of presenting inform ation in the SmPC.\nThe text on the label and the package leaflet are usually the only items the patient will see from all documents include d in a marketing authorization application, so it is very important th at the texts are clear and of a high quality. Knowledge of how to writ e a package leaflet and which guidance documents are important is also vital to pass the so-called “user testing” which is mandatory bef ore a medicinal product can be approved in the EU. Deviation from the guidelines should be justified in the Marketing Authorization Applicat ions. This webinar provides an overview of the relevant guidance docum ents and practical advice of how to write the Product Information.\nAr eas Covered in the Session:\nImportant EU product information guidance documents for the SmPCDiscussion of each section of the SmPCGuideline s on the packaging information and excipientsConsultation with Target Patient Groups\nWho Will Benefit:\nSenior managementProject ManagersMe dical writersCRAs and CRCsQA / Compliance personnelInvestigatorsClinic al Research ScientistsQA / QC Auditors and StaffConsultants\nSpeaker P rofile:\nAdriaan Fruijtier has graduated as a pharmacist at the Univer sity of Utrecht, The Netherlands.\nHe 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, Wupperta l, Germany, and Bayer Corporation, West Haven, CT, USA. Between 2001 a nd 2003 he was Director of Regulatory Affairs at Micromet AG, a biotec h company in Munich, Germany. Prior to joining Micromet he has worked during four years as a Project Manager for Oncology Projects at the Eu ropean Medicines Agency in London, United Kingdom.\nContact Detail:\nN etZealous - Compliance4All,161 Mission Falls Lane, Suite 216,Fremont, CA 94539, USA.Phone: +1-800-447-9407Email: support@compliance4All.comh ttp://www.compliance4all.com/Event Link : http://bit.ly/1WgYDMZ\n\nFo r more information visit https://medtechiq.ning.com/events/webinar-on- product-information-in-the-eu DTSTART;TZID=America/New_York:20151217T100000 DTEND;TZID=America/New_York:20151217T110000 CATEGORIES:webinar LOCATION:Online WEBSITE: URL: CONTACT:8004479407 ORGANIZER;CN="Adam Fleming":https://medtechiq.ning.com/profile/Complia nce4all ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/ file/get/2562012364?profile=original ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle ming":https://medtechiq.ning.com/profile/Compliance4all END:VEVENT END:VCALENDAR