Understanding the issues and risks pertinent to Medical Affairs is an area currently generating significant interest across the compliance and legal community. This includes topics on how Medical Affairs personnel interface with Commercial and Market Access colleagues, the use of alternative channels to deliver medical information, and the expanding roles of Field Medical personnel.
In addition, at the start of the year, the Food and Drug Administration (FDA) issued several documents impacting pharmaceutical and medical device companies’ medical communications:
- Draft Guidance Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers,
- Draft Guidance on Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities — Questions and Answers, and
- Memorandum on Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products.
The Summit will focus on these emerging topics impacting Medical Affairs as well as the Ethics and Compliance and Legal personnel who partner with them. Don’t miss this opportunity to discuss the potential issues and risks, share best practices, and build valuable relationships networking with your peers.
In addition, this Summit will overlap with the Second Pharmaceutical Summit on Business and Compliance Issues in Managed Markets (June 27-28). That agenda is available at www.PharmaManagedMarketsSummit.com. These events are being offered in sequence with a joint plenary session on June 27. You can register for both Summits and benefit from a discounted rate on registration.
WHO SHOULD ATTEND:
- Pharmaceutical, Medical Device and Health Care Executives and
- Board Members
- Employer and Health Plan Benefits Executives
- Compliance Executives
- Health Plan, Health System and Physician Organizations
- Medical Directors
- Pharmacists and Pharmacy Technicians
- Purchasers, including Private Employers and Public Purchasers
- Pharmaceutical Manufacturers
- Generic Pharmaceutical Manufacturers
- Site Management Organizations
- Clinical Research Organizations
- Pharmacy Benefit Management Companies
- Health Plans and Health Insurers
- Wholesale, Retail, Mail Order and Internet Pharmacies
- Health Care Attorneys and In-house Counsel
- Compliance Officers
- Privacy Officers
- Ethics Officers
- Food and Drug Law Attorneys
- Pharmaceutical Consultants
- Investment Bankers
- Venture Capitalists
- Health Care Regulators and Policy Makers
- Health Services Researchers and Academics