Complimentary McKesson webinar on FDA REMS

CBI's Complimentary Webinar: Submitting a Proposed REMS-- How to Comply with FDA Guidance

Sponsored By: McKesson

Date: Wednesday, January 13, 2010

Time: 12:00 PM - 1:00 PM ET 

Speakers:

• Ravi Deshpande, Pharm.D., Vice President Risks and Registry Solutions, McKesson Corp.
• Heather Morel, Vice President & General manager Reimbursement & Access Services, McKesson Corp.

In September, the FDA issued its draft guidance document "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications." The document reflects the FDA's current thinking about REMS and provides initial guidance and templates for REMS submissions to the FDA. It is the first guidance provided by the FDA on REMS since the Food and Drug Administration Act of 2007 was enacted and is a critical document for pharmaceutical and biotech manufacturers to understand and integrate with its go-to-market strategies.

This webinar provides:

·         Third-party interpretation and perspective on FDA REMS draft guidance document

·         Tips on completing REMS submissions following the templates and guidance of the FDA and based on real experiences

·         Perspective of FDA trends and patterns in imposing REMS programs

·         Increased awareness of potential future intentions of FDA when it releases its final FDA guidance document on REMS in 2010

To register, please click here. For more information, please visit our website.

Who should participate:

Drug Safety Medical Affairs Pharmacoepidemiology Pharmacovigilance Safety Surveillance Risk Assessment Adverse Event Reporting Regulatory Affairs Risk Management Medical Product Safety Assessment Phase IV/Post-Marketing Studies

Health Outcomes Global Drug Safety Global Medical Affairs Clinical Affairs Scientific Affairs Product Management Clinical Development Product Safety Safety Scientists Medical Advisor

Risk, Reward and the Pharmaceutical Life Cycle

Despite all the recent news about job cuts and lay offs, are you still interested in a non-clinical career in pharmaceutical medicine? Then you may be interested to know that there's another free live webcast coming up: "Risk, Reward and the Pharmaceutical Life Cycle: Managing Information as a Strategic Asset"

Live Webcast: December 2, 2009 at 11:00 AM EST

REMS, RMPs, RiskMAPS, the Sentinel Initiative and other FDA programs geared to identifying product safety risks before they emerge as public health challenges raise the bar on what the sponsors must do to comply. These include making significant investments in upgrading the quality and scope of surveillance data to track the impact of a medicine’s use on the patient community at every stage of its life cycle, from clinical trials to post marketing surveillance – in the latter case, this can now include obligations to monitor safety and risk well beyond the time of patent expiry.

In this new regulatory environment, relevant information must be accessible for analysis and reporting to meet strict regulatory time frames. In addition, the method of sharing this information with external parties must have controls in place to ensure the confidentiality of what, for knowledge-based industries like pharmaceuticals, is a key strategic asset. Technology such as configurable web-based exchange platforms can make this process more efficient by standardizing document distribution on a global basis, while adding a layer of control and reporting capabilities.

Key Learning Objectives :

• Learn how an understanding of regulatory methodology can facilitate rapid responses to safety queries
• Learn how web-based repositories and document distribution can facilitate access and submission of time-sensitive adverse event analyses and reports
• Understand how to quantify the time and money savings realized by moving your safety document distribution process online

Speakers:

Christopher Milne, PhD, DVM
Deputy Director and Lead Policy Advisor
Tufts University Center for the Study of Drug Development

Gail Farfel, PhD
GM Group Consulting

Robert Reynolds
Senior Director, Drug Safety and Regulatory Affairs
Pfizer, Inc.

Allison Shurell
Vice President, Product Marketing
IntraLinks

To register for this event, click here.

Free Webinar on Observational Research

What do you know about the FDA Amendments Act of 2007 (FDAAA)? How about Risk Evaluation and Mitigation Strategies (REMS)? Here's a brief summary of this free webinar:

It has been generally assumed within the industry that the FDA Amendments Act of 2007 (FDAAA) would increase the number of observational studies required by the FDA to monitor the long-term, real-world safety of new products (whether as part of a Risk Evaluation and Mitigation Strategies (REMS) plan or as a standalone study). Based on the post-marketing commitments included in new product approvals over the past year, however, it is not clear where the FDA will ultimately settle regarding interventional vs. observational safety studies.

Complimentary Webinar:

Future Directions of Observational Research: What we expected or plotting a new course?
Jul 30, 2009
2:00 PM - 3:00 PM EDT

This webinar reviews the merits and strengths of observational research in terms of safety surveillance, real-world product effectiveness, patient-reported outcomes and health economic measures.

Presented by: Dave Provost; Vice President, Global Post-Approval; INC Research

Dave Provost is responsible for management of the operational unit as well as for providing strategic consulting to clients regarding the design and implementation of their global late phase programs. He has nearly 20 years of pharmaceutical industry experience, all within the peri- and post-approval areas, and offers deep expertise in program design and implementation strategies. In addition to clinical research, Provost also has a background in health outcomes, market research and data collection and presentation technologies.

Click here to register.