New laws and recent changes to the FDA approach and the design and conduct of post-marketing surveil

Venue: PA

Location: Philadelphia, Pennsylvania, United States

Event Date/Time: Sep 25, 2012 End Date/Time: Sep 25, 2012
Registration Date: Sep 25, 2012
Early Registration Date: Sep 21, 2012
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This program is designed for biotechnology and pharmaceutical business executives, in­vestment bankers, advisors and their clients, and others with interests in the Risk Evaluation and Mitigation Strategies.

All innovative medical products approved for sale in the USA now have risk control and post-marketing surveillance requirements.

This workshop will provide you with the knowledge to understand the new FDA requirements for Risk Evaluation and Mitigation Strategies (REMS) and the tools to design these programs and execute post-marketing surveillance studies to evaluate the effectiveness of these programs.

The key utility of REMS programs are to provide risk control once a drug is marketed. REMS programs can include different mechanisms to control risk including: educational programs, pre-treatment risk screening, registration of prescribers and control of distribution.

One of the key elements of these programs is the description of real world patients using the medication and the determination of the post-marketing risk profile. Post-Marketing studies are different from randomized controlled trials and are based on observational study designs. In addition, because these studies are intended to represent ‘real-world’, data collection could be directly from patients and include physicians who have no prior experience with clinical research.

This workshop will teach you about:
How to work with the FDA to get REMS approval – when and what to file
Design and validation of REMS programs – pre and post-marketing
Design, approval, conduct and analysis of post-marketing studies
Case studies of approved REMS programs and post-marketing studies
New Draft Guidance
FDA Regulatory Requirements
Product Risk Management : Discussion with the FDA
Post-Authorisation Safety Studies(PASS)
Experience with Drugs Under Risk Management Programs
Significant Trends in the Market Place – next 2 years
Postmarketing Authorities in the US under FDAAA: PMRs and REMS
European Risk Management Plan (EU-RMP) Preparation
Section 505(o)(3) - Postmarket Studies and Clinical Trials
Section 505-1: Risk Evaluation & Mitigation Strategy (REMS)
New European Pharmacovigilance Directive
Pre-FDAAA: Postmarketing Commitments (PMCs)
Post-FDAAA: PMRs and PMCs
REMS Scope and Triggers
Change in MG-REMS Policy
Benefits of New Policy
Managing the Risks
REMS Must Be Designed To Address the Risks
Pre-NDA Meeting
Risk Minimisation Tools
Real World Risk Management
When Additional Risk Minimization May Be Required
Controlled Access Model


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Additional Information

Registration Details: Single Registration : USD $599 Group Registration (5 Members) : USD $2495 *Save USD $500 flat For Group Bookings, please send us an email to : or Call Us at : Ph : 1-646-216-8860