DIA Forum
Drug Information Association (DIA) is conducting an event called European Regulatory Affairs Forum which will be held from 24th November 2008 in Munich, Germany.
Drug Information Association (DIA) is conducting an event called European Regulatory Affairs Forum which will be held from 24th November 2008 in Munich, Germany.
By attending this meeting audiences will learn about:
• Exploring possibilities given by new medicines legislation
• Opportunities and challenges of the global dimension – confidentiality agreements
• MRP, DCP and CP performance and critical factors
• Evolving regulatory framework of European pharmacovigilance
• The increasing scope of electronic interaction between applicants and regulators within the regulatory business.
Target Audience:
Professionals involved in the following areas:
• Regulatory Affairs and Operations
• Pharmacovigilance
• Project Planning
• Clinical Research and Operations
• eSubmission.
Can we request you to update the calendar of events on your website to include the details of this event? The details of the event are given below as well as attached. Please let me know if you need any further information.
Event Name European Regulatory Affairs Forum
Event Date Nov 24 2008 - Nov 25 2008
Event Location Le Meridien Hotel Munich, Munich, Germany.
Event Description Overview: • Scientific Advice and the Transatlantic Simplification Process • Centralised procedure: New market authorisation procedures and case studies • Update on Variation Regulations • Update on CMD(h) - Activities and the network • MRP / DCP procedures • Choice of RMS and availability of NCA resources • CMD(h) and CHMP referrals - interaction and case studies • Harmonisation of SmPCs of national MA's • The proposed new Pharmacovigilance Legislation • PSUR work-sharing and the link between PSURs and risk management plans • Transparency and public disclosure - Risk communication guideline - EudraCT and the impact of Paediatric Regulation • Risk management plans and Post Authorisation Safety Studies (PASS) • Risk management case studies • Telematics Roadmap and impact on regulatory business • Centralised procedure: eSubmission practicalities, Product Information Management (PIM) and case studies • NCA implementation of electronic initiatives: eCTD and NeeS
Event Website http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16916&eventType=Meeting <http://www.diahome.org/DIAHOME/Education/FindEducationalOffering.aspx?productID=16916&eventType=Meeting>
Contact Person Senior Manager of Marketing
Contact E-Mail ID talana.bertschi@diaeurope.org
Contact Phone +41 61 225 51 51
Contact Fax +41 61 225 51 52
Sponsoring Company Name Drug Information Association
Company Website http://www.diahome.org <http://www.diahome.org/>
Company Address Drug Information Association, European Branch Office, Basel, Switzerland.
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