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Presents:

Hot Topics in European Legislation


11 March 2008
Overview: This presentation will primarily focus on four areas of European Legislation. European clinical trials legislation update:
The European clinical trials legislation has been in force for a few years now, and the European Commission and EMEA recently held a joint conference to discuss the operation of the new rules and to look at possible future changes to the legislation/guidelines. The key findings and proposed measures are discussed.

Registration Deadline: Payment MUST be received no later than Wednesday 5 March 2008. Space may be limited; advance registration is recommended. RAPS does not accept checks in Canadian Dollars. It is suggested to register online with a credit card. If paying by check in US$, registration and check must arrive by deadline. Send Full Payment: By mail: RAPS c/o SunTrust Bank Lockbox Dept., PO Box 79546, Baltimore, MD 21279-0546 By fax: +1 301 770 2924 (credit card only) Online Information & Registration: Visit www.raps.org Click on Member Center in the upper lefthand column, and then click on Chapters. You will find listings of upcoming chapter events along the right-hand column. Cancellations: Are not accepted; substitutions welcomed with advance notification. Applicable fees apply to substitute registrant. Registration Questions: Call RAPS Solutions Center at +1 301 770 2920, ext. 200.

The new Advanced Therapy Medicinal Products Regulation:


The recently published EU Regulation on Advanced Therapies covers new medicinal products based on genes, cells and tissues, and introduces harmonized rules for the authorization of these products across all EU Member States. This talk provides an overview of the new rules.

Risk Management Plan:


A Guideline on Risk Management Systems for Medicinal Products for Human Use came into effect at the end of 2005. An overview of the format, content and dependencies of the risk management system as a set of pharmacovigilance activities and interventions designed to identify, characterize, prevent or minimize risks relating to medicinal products is presented.

Pediatric Investigational Plan:


New legislation governing the development and authorization of medicines for use in children was introduced in the EU in January 2007 and requires a Pediatric Investigational Plan for all new Marketing Authorization Applications after 26 July 2008. This presentation provides an overview of the new pediatric regulations, and format and content of the Pediatric Investigational Plan.

Speakers: Dawn Spark, BSc, MA, Sr. Regulatory Affairs Consultant Fulcrum Pharma plc Virginia Anastassova, MSc, RAC, Regulatory Affairs Specialist AnorMed Corporation of Genzyme Corporation Date/Time:

11 March 2008
Registration & Networking 5:306:00pm Presentation & Q/A Session 6:008:00pm

Location: QLT Inc., 887 Great Northern Way, Vancouver, BC Program Content Contact: Dana Nohynek, MSc, RAC, dnohynek@migenix.com; Jamie Robinson, RAC, jrobinson@cardiome.com Registration Contact: Wesley Carr, +1 301 770 2920 or wcarr@raps.org.

Registration Fees: RAPS Member

$20 (Member ID _____________) Nonmember

$30

0822406

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