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SECOND ANNUAL RISK MANAGEMENT & DRUG SAFETY SUMMIT

 

* Presented by FDAnews in Conjunction with United BioSource Corp & Center for Medicine in the Public Interest

* Early-Bird Rate in Effect Though September 11 -- Register Now for Best Rate

* Oct 01-02 2009 -- National Press Club, Washington DC

http://www.DrugSafetySummit09.com

 

 

FDAnews, in conjunction with United BioSource Corp and the Center for Medicine in the Public Interest, announced today they are hosting the Second Annual Risk Management & Drug Safety Summit on Oct 01-02 2009 at the National Press Club, Washington DC.

 

 

BACKGROUND

 

Clinical research, drug development, regulatory approval and pharmacovigilance segments of the drug and biologic industries are at a crucial crossroads. New risk management programs from the FDA, known as REMS, promise a competitive advantage to companies that incorporate REMS early in the NDA approval cycle, then stay close to the FDA through post-market monitoring and beyond. But compliance challenges are daunting.

 

How do you evaluate the effectiveness of your REMS? What is the impact of developing a REMS on your clinical trials, organizational structure, reporting and governance? What lessons have REMS pioneers learned that might benefit you? These are but a few of the questions swirling around this new get-tough approach to risk management and drug safety regulation.

 

Come to Washington DC, Oct 1-2, and discover how your company can cope with and adjust to REMS. The SECOND ANNUAL RISK MANAGEMENT & DRUG SAFETY SUMMIT is set for Oct 1-2, at the National Press Club, Washington DC.

 

 

FDA SPEAKERS TO INCLUDE:

 

* Janet Woodcock MD; Director, CDER, FDA

* Jane Axelrad; Assoc Dir for Policy, CDER, FDA

 

 

In addition, the top UK drug regulator has been invited as a special presenter. Hon. Sir Alasdair Breckenridge is Chair, Medicines & Healthcare Products Regulatory Agency, UK.

 

Eight more speakers representing leading drug makers as well as industry consultants and attorneys, round out the program:

 

* Carmen Bozic MD; VP Drug Safety & Risk Mgmt, Biogen Idec

* Juergen Schmider MD PhD; VP Global Pharmacovigilance & Epidemiology, Cephalon

* Philippe van der Auwera MD PhD; Global Head, Safety Risk Mgmt, F. Hoffmann-La Roche AG

* Gerald Faich MD MPH FISPE; Sr VP Safety, Epidemiology, Registries & Risk Mgmt, United BioSource Corp

* Meredith Manning Esq; Partner, Hogan & Hartson

* Florence Houn MD; VP Regulatory Policy & Strategy, Celgene

* Mark Ammann PharmD; VP Regulatory Affairs, United BioSource Corp

* Brian Harvey MD PhD; VP Regulatory Policy, Sanofi-Aventis US

 

 

FURTHER PROGRAM DETAILS:

 

Full program details and registration information is available at:

http://www.DrugSafetySummit09.com or by calling 888-838-5578.

 

 

CONFERENCE REGISTRATION INFORMATION

 

CONFERENCE CO-CHAIRS:

 

* Annette Stemhagen DrPH FISPE; VP, Epidemiology & Risk Management, United BioSource Corp

* Peter Pitts; Co-Founder & President, Center for Medicine in the Public Interest

 

 

WHO SHOULD ATTEND:

 

* Executive Management

* Regulatory Affairs

* Medical Affairs

* R&D

* Clinical Trial Directors

 

 

LOCATION & HOTEL ACCOMMODATIONS:

 

The National Press Club is at the corner of 14th & F Streets NW, in the heart of downtown Washington DC. Hotel rooms have not been blocked for this event. For a list of 3-to-5-star hotels within walking distance, please visit http://www.DrugSafetySummit09.com or call 888-838-5578.

 

TEAM DISCOUNTS:

 

Significant discounts are available for teams of three or more from the same company. You must register at the same time and provide a single payment to take advantage of this discount. Call 703-538-7600 for details.

 

TUITION:

 

Early-Bird Rate Through Sept. 11: $1,997

Regular Rate After Sept. 11: $2,297

 

REGISTER TODAY:

 

1. Enroll online at http://www.DrugSafetySummit09.com

2. Call 703-538-7600 or 888-838-5578

3. Use your American Express, Visa or MasterCard

4. Mail your check to:

FDAnews

300 N Washington St Ste 200

Falls Church VA USA 22046-3431

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