Fifth Annual Risk Management and Drug Safety Summit Building An Effective Global Risk Management and Drug Safety Program

$1,967.00
 

There are now about 200 unique REMS and four classwide REMS.  And big changes are coming.

PDUFA V moves REMS discussions earlier in the review process for sponsors of new molecular entity NDAs and original BLAs. With REMS discussions commencing as early as pre-NDA meetings, the agency is determining how to create a more predictable system for requiring REMS and deciding what tools a REMS should involve.

CDER (in conjunction with CBER) plans to issue new guidance to determine when a REMS is required, both preapproval and postapproval. The guidance must be released in September 2013.

Plus, the FDA is planning to hold a series of public meetings to determine the best methods for assessing the effectiveness of REMS.

Are you in the know on these changes?  Will you be ready when they hit your product?

Register today to join a select group of drug industry executives who have, over the past four years, sought to shape the future of REMS and global drug safety.

This is your year to be among them.  Register now to join with colleagues for the Fifth Annual Risk Management and Drug Safety Summit.

Invest two days. Meet new colleagues and make new contacts. Ask questions directly of industry thoughts leaders, such as Douglas Throckmorton, M.D., Deputy Director Regulatory Programs, CDER, FDA (invited), Greg Fiore, M.D., Chief Medical Officer and Acting Head of Global Pharmacovigilance, The Medicines Company and Richard Hermann, M.D., M.P.H., Safety Science Physician, AstraZeneca.

You’ll also be brought up to speed on these critical topics:

  • CDER’s Efforts to Improve Risk Management and Drug Safety
  • Problems Encountered When Innovator and Generic Firms Have to Share a REMS
  • How to Design an Effective ETASU with Integrated Digital Elements
  • Suspicious Order Monitoring (SOM) Regulatory and Policy Requirements — An Effective Investigative Program
  • Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D
  • Panel Discussion: Opioid REMS and What It Signals for the Future of REMS
  • The Powerful New Platform for Risk Management and Safety Communications: Electronic Health Records
  • Pharmacoepidemiology in Safety Signal Assessment

How will the Fifth Annual Risk Management and Drug Safety Summit make a bottom-line difference to you?  Here’s what previous attendee Parul Vold, Medical Director, Global Pharmacovigilance, Lundbeck, Inc., said:

“This is the best conference on risk management that I have ever attended. It is money well spent. Even seasoned pharmacovigilance persons will learn something new and/or gain a valuable new perspective.”

Peter Pitts is co-founder and president of Center for Medicine in the Public Interest.  Prior to founding CMPI, Mr. Pitts was a senior fellow for healthcare studies at the Pacific Research Institute, a San Francisco-based think tank.  From 2002-2004, he was the FDA’s associate commissioner for external relations, serving as the agency’s “chief messaging officer,” where his challenge was to clearly define the FDA’s brand image and to communicate the agency’s main themes to its many constituencies.

Host Sponsor:

Center for Medicine in the Public Interest is a nonprofit, nonpartisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, healthcare reform and comparative effectiveness.

Register Today

  • Executive Management
  • Regulatory Affairs
  • Risk Management Professionals
  • Clinical Safety/Pharmcovigilance
  • Medical Affairs/Medical Safety
  • Research and Development
  • Commercial Affairs/Business Development
  • Clinical Trial Directors

For 2012 exhibit options and sponsorship packages contact Colette McMullen, Director, Business Development at (703) 538-7642 or cmcmullen@fdanews.com

The National Press Club
529 14th Street, NW
Washington, DC 20045
Tel: +1 (202) 662-7500
www.press.org

Hotel Accommodations:
Hotel rooms have not been designated for this event. For your convenience please refer to a list of the nearest hotels to the National Press Club.

W Washington DC (0.1 miles)
515 15th Street NW
Washington, DC 20004
(202) 661-2400
JW Marriott Hotel Pennsylvania Avenue (0.1 miles)
1331 Pennsylvania Ave, NW
Washington, DC 20004
(202) 393-2000
The Willard Washington DC (0.1 miles)
1401 Pennsylvania Ave NW
Washington, DC 20004
(202) 628-9100
Sofitel-Lafayette Square (0.3 miles)
806 15th St NW
Washington, DC 20005
(202) 730-8800
Hilton Garden Inn Washington DC (0.3 miles)
815 14th Street NW
Washington, DC 20005
(202) 783-7800
Marriott at Metro Center (0.3 miles)
775 12th Street NW
Washington, DC 20005
(202) 737-2200
Grand Hyatt Washington (0.4 miles)
1000 H Street NW
Washington, DC 20001
(202) 582-1234
Crowne Plaza Hotel — The Hamilton - Washington DC (0.4 miles)
1001 14th St NW
Washington, DC 20005
(202) 682-0111

Register for 2012:

Hurry — register early because space is limited! Your tuition includes the day and a half summit, all conference materials, continental breakfast each day and lunch on the first day.

 
Fee
Executive Briefing
$1,967

Send Your Team for Maximum Benefit
Get your team up to speed!

Significant tuition discounts are available for teams of two or
more from the same company. You must register at the same time and
provide a single payment to take advantage of the discount. Register below
by clicking on add to cart and then change your quantity in the shopping cart.
The discount will be calculated automatically.

2-4 attendees – 10%
7-9 attendees – 20%
5-6 attendees – 15%
10+ attendees – 25%

Call (888) 838-5578 in the U.S. or +1 (703) 538-7600
globally with any questions.

Payment is required by the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to FDAnews.

Or, register by phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600.

Cancellations and Substitutions

Written cancellations received at least 21 calendar days prior to the start date of the event will receive a refund — less a $200 administration fee. No cancellations will be accepted — nor refunds issued — within 21 calendar days from the start date of the event. A credit for the amount paid may be transferred to any future FDAnews event. Substitutions may be made at any time. No-shows will be charged the full amount. In the event that FDAnews cancels the event, FDAnews is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.