Webinar on Product Information in the EU
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.
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.
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
Contact Detail:
NetZealous - Compliance4All,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.
Phone: +1-800-447-9407
Email: [email protected]
http://www.compliance4all.com/
Event Link : http://bit.ly/1WgYDMZ
Speaker and Presenter Information
Speaker Profile:
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.
Relevant Government Agencies
Dept of Education, Dept of Health & Human Services, Information in the EU
Event Type
Webcast
This event has no exhibitor/sponsor opportunities
When
Thu, Dec 17, 2015, 10:00am - 11:00am
ET
Website
Click here to visit event website
Organizer
NetZealous - Compliance4All
Join the event conversation:
@Compliance4all
