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Establishing an Effective REMS Process: Significant Implications of Risk Management


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Transforming the field of pharmaceutical risk management, the Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the U.S. Food and Drug Administration (FDA) the authority to require a Risk Evaluation and Mitigation Strategy (REMS) from a manufacturer to ensure that the benefits of a drug or biological product outweigh the risks.

Today – from request through acceptance – the REMS process remains a daunting one. And its multidisciplinary scope demands constant cross-company synchronization – from Phase I studies through clinical development, to regulatory review, approval, and commercialization.

Whether you’re an industry veteran or a relative newcomer, understanding REMS is both a challenge and a requirement, which is why this two-day workshop should be requisite learning for all pharmaceutical professionals.

What You’ll Cover:

 

The History of REMS and Risk Management

The workshop will review the history and background of the FDA’s risk management processes and analyze the key risk management provisions of the FDAAA. Through a combination of hands-on activities and expert presentations, you will be able to clarify the current challenges of today’s risk management process.

 

REMS Guidance

You will discuss the initial FDA guidance on REMS, the current information provided to companies as they prepare to establish an approved REMS, and any issues that have not yet been addressed by the agency. You will also address the most pressing guidance needs and share how various stakeholders – the FDA, the pharmaceutical industry, healthcare providers, and others -- have expressed their concerns with the REMS process at this point in time.

 

REMS Programs: In Review

A review of major REMS programs will provide insight into challenges presented by individual products in the creation of an effective risk management process. Participants will benefit from a detailed description of regulatory activity and industry responses, beginning with the approval of the first REMS programs shortly after the passage of FDAAA, through to present day.

 

The Drug Development Lifecycle

Tracing the drug development lifecycle – from development through commercialization -- will enable you to identify those opportunities where the identification and reporting of information relating to safety may impact the benefit/risk profile of a compound or drug.

 

REMS in Context

You will review the REMS process within the context of other FDA initiatives, including the establishment of the FDA Transparency Task Force and the rise of Social Media, and recognize how these activities can impact the implementation of REMS.

 

Unresolved Issues

Discussions will address various unresolved issues facing companies that are affected by REMS, including:

  • Establishing the success of a REMS program
  • Practical implications of REMS on the practice of medicine and drug utilization
  • How REMS can impact a company’s product liability exposure
  • To what extent REMS will change the environment for generic drug use
  • How companies can anticipate imposition of a REMS and the most opportune time to seek FDA input and guidance
  • To what extent can third parties impact the decision to require a REMS
  • Whether a proactive approach to requesting a REMS is ever appropriate
  • Likelihood of expansion of the REMS process or component parts to the Medical Device manufacturers and processes to consider implementing now

Register now and join your peers in Philadelphia!

 

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FEATURED INSTRUCTOR

Howard Dorfman

Howard Dorfman

Vice President, General Counsel

Ferring Pharmaceuticals

With over 30 years of industry experience, Howard Dorfman has intimate knowledge of the PhRMA Code, OIG compliance, and FDA-related legislation, as well as federal and state fraud and abuse regulations and statutes. He established OIG compliance procedures at a major pharmaceutical company while counseling on Medicare, Medicaid, and other healthcare reimbursement matters. Liaising with international stakeholders, Mr. Dorfman has developed FDA risk management plans and global drug labeling protocols in accordance with U.S. regulatory standards.

Mr. Dorfman is a former Chief Legal Officer of the Pharmaceutical Division of Bayer Healthcare LLC, where he was responsible for legal oversight relating to the commercial, regulatory, and compliance activities of the company's pharmaceutical operations. He earned his J.D. from the Brooklyn Law School.

REGISTRATION

Hotel Information

Hotel: Sofitel Philadelphia

Address: 120 South 17th Street, Philadelphia, PA 19103

Phone: 215.569.8300

Date: March 7th & 8th, 2012

Website: http://www.sofitel.com/gb/hotel-2741-sofitel-philadelphia/index.shtml

Early Bird Price = $1399  $1119.00

Register by 2/15/12 and save an extra
20% off the early bird price.

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Regular Price = $1699.00

Price after 2/15/12.

Reservations: All reservations must be made individually by calling the hotel reservations department and referencing "Elsevier Business Intelligence Meeting."

Cancellations: Written cancellations received at least 21 days prior to the start date of the event will receive a refund, less a $300 processing fee. No refunds will be issued for cancellations within 21 days from the start date of the event. At that time, a credit for the amount paid, less a $300 processing fee, may be transferred to another Elsevier Business Intelligence event. No-shows will be charged the full amount. Substitutions may be made at any time by contacting Customer Care.

If the event is cancelled, you may receive a full refund. If the event is postponed, you may substitute someone else from your company. Elsevier Business Intelligence is not responsible for airfare, hotel, or other costs incurred by registrants.