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AUDIOCONFERENCE ON TAPE OR CD

From the company that offers customized compliance training for Medical Science Liaison Teams

presented on OCTOBER 10, 2006

“The cost of producing a successful drug could top $2 billion by 2010”

- Steven Paul, Executive Vice President, Eli Lilly, Drug Discovery Technology conference, Boston, August 2006

So how do you create effective awareness when the legal boundaries aren't clear in the pre-market phase? With murky guidelines, managing KOLs and your pre-market educational activities is one of your biggest daily headaches and compliance worries. Trusted for delivering high-level advice, we've brought back Mark DuVal, former 3M Pharmaceuticals general counsel, to provide compliance commentary and help you push the envelope--within the rules--as you try to manage your pre-approval activities. In a back and forth style, Dr. Jeffrey Spears, PharmD, will present the scenarios and creative awareness strategies while Mark DuVal addresses the legal considerations.

AGENDA

Scenario One:

Your company doesn't currently have a product in the marketplace and/or therapeutic segment so it needs to educate the end user and medical community. What pre-approval activities can be used? Any new ideas/concepts that will remain compliant?

Scenario Two:

How can you make the medical community aware of product risks? Can and how should you develop a business plan for the KOLs in their specific geographies? Is an ROI analysis appropriate?

Scenario Three:

Unapproved compound – can an MSL provide great questions/information on a first visit to create awareness without going outside of legal/regulatory boundaries?

Scenario Four:

MSL's role in establishing/supporting CME and non-CME programs

Scenario Five:

Vignette on establishing/supporting speaker programs and ad boards

Q & A

MEET OUR SPEAKERS

Dr. Jeffrey Spears, PharmD is Senior Director of Medical Education at EMD Pharmaceuticals, a US affiliate of Merck KGaA, Darmstadt, Germany. He is responsible for EMD’s field based medical program, CME and non-certified medical education grants, and health outcomes. He has more than ten years of experience in the pharmaceutical industry. Prior to joining EMD, Jeff held the position of Executive Director, Medical Services, a similar position at Mylan Bertek Pharmaceuticals. Prior to this he was Regional Director for Global Clinical Sciences at Pharmacia Corporation. He has also held the positions of Assistant/Associate Director of Regional Healthcare Services, Senior Medical Affairs Manager and Medical Affairs Manager for Searle Pharmaceuticals. In addition, Jeff has worked in Regulatory Affairs, Quality Assurance, Marketing and Information Technology areas for HBO & Company, IBAX Healthcare Systems, Baxter Healthcare Corporation and Travenol Laboratories, Inc.

Mark DuVal, J.D., is President and Managing Partner of DuVal & Associates, where he counsels pharmaceutical, medical device, biotech, food and nutritional supplement companies. Mr. DuVal spent almost 15 years as general counsel to Pharmaceuticals and 3M Drug Delivery Systems with his last year in Europe with 3M Health Care, Ltd. He then worked as corporate regulatory and compliance counsel at Medtronic. Having worked extensively with drug delivery systems businesses, Mr. DuVal's practice also includes combination products, specifically drugs and devices as well as biologics and devices. He regularly advises clients in all areas of FDA law and regulation, from product development, clinical trials, inspections and recalls to reimbursement and compliance issues and post-marketing responsibilities. Mr. DuVal specializes in counseling medical device and pharmaceutical companies in the development and implementation of strategic and tactical sales and marketing plans that are appropriately aggressive, yet compliant.

WHO SHOULD ATTEND?

• Medical Science Liaison Directors
• Medical Science Liaisons
• Medical Affairs
• Medical Education
• VPs/Directors of Marketing
• VPs/Directors of Medical Affairs
• Compliance Officer/Manager
• Legal Counsel

Purchase a tape or CD of the program and listen when you can. It's a perfect training tool for new staff or as a refresher for veteran staff.

PROGRAM MATERIALS

Program materials will be provided with PDF links.

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