Seminar on Regulatory Affairs aspects of clinical trials and clinical Product Development in the EU at Baltimore, MD

Course "Regulatory Affairs aspects of clinical trials and clinical Product Development in the EU" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:

The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider.

The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained.

Scientific advice is a vital element in the development of a medicinal product, and knowledge of the how to choose between national and EU scientific advice, as well as the preparation and procedure is vital for a successful outcome

An overview of the current process for clinical trial applications is included, but the Seminar will also look ahead and describe the effects of the Clinical Trials Regulation.

The Clinical Trials Regulation aims to create an environment that is favorable for conducting clinical trials, with the highest standards of patient safety, for all EU Member States. Intrinsic to this is the simplification of current rules, for example:

• A streamlined application procedure via a single entry point - an EU portal and database, for all clinical trials conducted in Europe. Registration via the portal will be a prerequisite for the assessment of any application;
• A single authorisation procedure for all clinical trials, allowing a faster and thorough assessment of an application by all Member States concerned, and ensuring one single assessment outcome and authorisation per Member State;
• The extension of the tacit agreement principle to the whole authorisation process which will give sponsors and researchers, in particular SMEs and academics, more legal certainty;
• Strengthened transparency for clinical trials data.

Speaker:

Adriaan Fruijtier

Regulatory Affairs Consultant, CATS Consultants GmbH 

Location: Philadelphia, PA Date: February 11th & 12th 2016 and Time: 9:00 AM to 6:00 PM

Venue: Hilton Garden Inn Philadelphia Center City

Address: 1100 Arch St, Philadelphia, PA 19107, United States

Price:

Register now and save $200. (Early Bird)

Until January 10, Early Bird Price: $1,295.00 from January 11 to February 09, Regular Price: $1,495.00

Quick Contact:

NetZealous DBA as GlobalCompliancePanel

Phone: 1-800-447-9407

Fax: 302-288-6884

Email: support@globalcompliancepanel.com      

Website: http://www.globalcompliancepanel.com

Registration Link - http://bit.ly/Regulatory-Affairs-aspects-of-clinical-trials-at-Philadelphia-PA