Fifth Annual Risk Management and Drug Safety Summit Agenda

DAY ONE: Monday, Dec. 3

8:00 a.m. – 8:30 a.m.

Registration and Continental Breakfast

8:30 a.m. – 8:45 a.m.

Chair: Welcome and Introduction

8:45 a.m. – 9:45 a.m.

CDER’s Efforts to Improve Risk Management and Drug Safety
While PDUFA V is fresh out of the halls, the goals of the FDA remain the same: oversight of the entire life cycle of drugs — from premarket drug testing and development through drug approval, postmarket surveillance and risk management.

Attendees will learn:

  • How CDER is using additional resources and enforcement authorities to improve postmarket surveillance and drug safety
  • What changes the agency has made in response to the globalization of the industry and international risk management concerns
  • The FDA’s efforts to strengthen the science that supports drug safety at every stage of the drug life cycle
  • How the FDA’s Sentinel Initiative will improve postmarket surveillance and safety

Douglas Throckmorton, M.D., Deputy Director Regulatory Programs, CDER, FDA (invited)

9:45 a.m. – 10:30 a.m.

Change Management Within Pharmacovigilance – Shifting our Focus Back to the Patient

Greg Fiore, M.D., Chief Medical Officer and Acting Head of Global Pharmacovigilance, The Medicines Company

10:30 a.m. – 10:45 a.m.

Morning Break

10:45 a.m. – 11:30 a.m.

Problems Encountered When Innovator and Generic Firms Have to Share a REMS

Josephine Torrente, J.D., Director, Hyman, Phelps & McNamara

11:30 a.m. – 12:15 p.m.

Top Legal and Compliance Challenges that Lie Ahead

Stuart Kim, J.D., Senior Regulatory Counsel, Pharmaceuticals, Covidien

12:15 p.m. – 1:15 p.m.

Lunch Break

1:15 p.m. – 2:00 p.m.

How to Design an Effective ETASU with Integrated Digital Elements
One of the most challenging issues confronting REMS strategy and implementation today is integrating REMS activities with company websites and other digital elements.  If you’ve ever wondered what’s working within the intersection of REMS, ETASU and patients, you can’t miss this session.

Attendees will learn:

  • What works and what doesn’t within the range of approaches to using digital tools
  • How integrating digital elements influences the overall ETASU goals
  • The most important factors you need to know to design effective digitally driven ETASU

Dale Cooke, Vice President/Group Director, Regulatory Review, Digitas Health

2:00 p.m. – 2:45 p.m.

Maintaining Inspection Readiness While Guidelines Change: New EU Pharmacovigilance Legislation
This session explains how pharmaceutical companies can best handle inspections and audits in the midst of undergoing significant departmental and operational changes in the EU. It will dive into how companies can embrace change management strategies quickly and effectively to remain compliant with the new legislation.

Attendees will learn:

  • How adapting to the new EU guidelines may take internal restructuring and reformatting of operational standards
  • The compliance monitoring and external assessment of PV during the transition and implementation stages
  • How to prepare for inspections of premises, records, documents and the transition from DDPS to PSMF
  • How to review and monitor RMPs to be in accord with a product’s marketing authorization
  • How to strengthen communication of safety of medicines with all external and internal stakeholders

Eleanor Segal, M.D., Biopharmaceutical Consultant, Segal PV Systems

2:45 p.m. – 3:00 p.m.

Afternoon Break

3:00 p.m. – 3:45 p.m.

Suspicious Order Monitoring (SOM) Regulatory and Policy Requirements — An Effective Investigative Program
This session will present an analysis of the diversion and abuse of controlled substances that are manufactured in the US and distributed through US manufacturers and distributors, prescribed by physicians and dispensed by pharmacies, clinics, hospitals and pain clinics. Because of the diversion and abuse of pharmaceutically manufactured controlled substances, the Drug Enforcement Administration (DEA) has conducted a number of investigations that have resulted in multimillion dollar civil fines, suspension and revocation of DEA registrations, etc. The presentation will detail investigative techniques, “know your customer,” due diligence of new and existing customers, effective and compliant approaches for clearing pending orders, tracking distributions, details of handling DEA reporting and little known industry challenges

Attendees will learn:

  • Federal SOM regulatory requirements
  • The history and development of SOM reporting
  • The five elements of an effective SOM program
  • The common red flags to look out for during an on-site review. 

Ronald Buzzeo, RPh, Chief Compliance Officer, Cegedim Compliance Solutions, Cegedim

3:45 p.m. – 4:45 p.m.

Panel Discussion: Opioid REMS and What It Signals for the Future of REMS
On July 9, 2012, the FDA approved a REMS for extended-release (ER) and long-acting (LA) opioid medications. The REMS is part of a multi-agency federal effort to address the growing concern about patient safety. The REMS introduces new safety measures to reduce risks and improve safe use of ER/LA opioids while continuing to provide access to these medications for patients in pain. The panel will discuss in detail how it is affecting the industry and what this means for all REMS going forward.

Moderator: Lynn Mehler, J.D., Partner, Hogan Lovells

4:45 p.m. – 6:15 p.m.

Networking Reception

DAY TWO: Tuesday, Dec. 4

8:00 a.m. – 9:00 a.m.

Registration and Continental Breakfast

9:00 a.m. – 9:15 a.m.

Chair: Welcome and Introduction

9:15 a.m. – 10:00 a.m.

Application of the Benefit-Risk Action Team (BRAT) Framework in Pharmaceutical R&D - Results from a 2011 Pilot Program Conducted Among PhRMA Member Companies.
Benefit-risk (B-R) assessments inform decisions regarding drug development and lifecycle management, serve as a basis for regulatory determinations, and help clinicians, patients and payers make rational, value-based treatment decisions. The B-R Action Team (BRAT), formed by the Pharmaceutical Research and Manufacturers of America (PhRMA), has developed a structured approach to B-R assessment—the ‘‘BRAT Framework’’—that assists decisionmakers in selecting, organizing, summarizing and communicating evidence relevant to B-R decisions. Here we report results of a pilot program to assess the value of the framework in pharmaceutical development and post-marketing settings, for the purpose of informing PhRMA’s regulatory advocacy.

Attendees will learn:

  • What the BRAT Framework is
  • Individual company experiences with using the BRAT
  • Overall summary of pros and cons of using the Framework

Richard Hermann, M.D., M.P.H., Safety Science Physician, Patient Safety, Global Regulatory Affairs, AstraZeneca

10:00 a.m. – 10:45 a.m.

Pharmacoepidemiology in Safety Signal Assessment
Pharmacoepidemiology provides the means by which potential safety signals may be assessed and placed into context. During both clinical development and life-cycle management, pharmacoepidemiologic data may suggest what is the background rate of a particular adverse event, specific demographic or other potential confounding factors associated with the adverse event, the degree to which the event is being reported (as compared with its incidence rate), and the characteristics of those persons at high risk for experiencing a specific adverse event. The strengths and weaknesses of pharmacoepidemiologic activities in the assessment of potential safety signals will be discussed and potential sources of such data described

Attendees will learn:

  • Best practices with regard to pharmacoepidemiology studies
  • Where to obtain pharmacoepidemiology data
  • Practical examples of pharmacoepidemiology in safety signal assessment and resolution
  • Issues attending the use of pharmacoepidemiologic data during clinical development and in the postmarketing approval setting
David Lilienfeld, M.D., Principal, Write for the Pharm, LLC

10:45 a.m. – 11:00 a.m.

Closing Comments

11:00 a.m.

Conference Adjournment