3-Hour Virtual Seminar on Off label Promotion of Drugs and Medical Devices - FDA's Latest


Tuesday, June 5, 2018   |   10:00 AM PDT | 01:00 PM EDT   |   Duration: 3 Hours          

Live

One Dial-in One Attendee

Price: US$290.00


Corporate Live

Any number of participants

Price:US$490.00


Duration: 3 Hours  

Recorded

Access recorded version,
only for one participant ?

Price: US$340.00

Corporate Recorded

Access recorded version,
Any number of participants ?

Price: US$540.00

This session will discuss the guidance "Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities" which explains the FDA's current thinking, also this session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents.
Angela Bazigos   Product Id : 501686
  Instructor : Angela Bazigos

  More Trainings by this Expert


Overview:

Off Label Promotion for Drugs and Medical Devices is a controversial topic which often puts FDA and industry at loggerheads. FDA continues to need to ensure public health by protect public health by ensuring that medical products distributed in the United States are safe and effective for their intended use while industry believes that safe and effective off label use is warranted. It is further complicated by today's patient who is much more savvy with regards to treatment and sometimes demands off-label use of products.

Why should you Attend: This class presents the latest FDA, industry & patient thinking to assist manufacturers in enhancing the predictability, consistency, and transparency of off-label promotion of medical products, and describing in greater detail the regulatory framework, policies, and practices underlying such a decision. The views of FDA, industry and patients will be presented and the latest concurrences and issues will be described.

Areas Covered in the Session:
Session #: 1
Duration: 30 minutes
Learning Objectives: This session sets the context for the off-label promotion of medical products starting with early history and moving to the most recent history of FDA's decision on guidance documents.

  • Early History of Off-Label Promotion of medical products including some common household products such as Listerine and Ketchup that were originally used for patient treatment
  • Snake Oil Salesmen and the FDA
  • FDA: between patients and industry
  • Off-Label Promotions and First Amendment Issues
  • Federal Register History of the current guidance documents

Session #: 2
Duration: 30 minutes
Learning Objectives: As explained in the previous session FDA is always balancing the needs of the patient against the demands of the industry. Today's patients create additional issues for FDA and industry in that they bear a materially higher burden of medical payments plus have access to online tools. These make today's patient much more demanding with their treatment and requests for off-label use of medical products.
  • Today's healthcare environment for patients
  • Patient expectations
  • FDA & Industry response
  • How today's patient influences off-label promotion of medical products
  • Patients' comments

BREAK -

Session #: 3
Duration: 30 minutes
Learning Objectives: This session will describe the issues that FDA and industry face in making the decisions re off-label promotion of medical products. It will present each side of the equation and will include First Amendment and Fifth Amendment Issues. Court hearings on the subject will be presented.
  • FDA Position
  • Industry Position - Is the FDA Listening?
  • Legal Considerations
  • Where are we today?

Session #: 4
Duration: 30 minutes
Learning Objectives: This session will discuss the guidance "Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities" which explains the FDA's current thinking and recommendations on firms' communication of health care economic information (HCEI) about approved drugs under section 502(a) of the FD&C Act, which was recently amended by the 21st Century Cures Act. It also answers common questions and provides the FDA's recommendations regarding firms' communications to payors about investigational drugs and devices that are not yet approved or cleared for any use.
  • Introduction
  • Background
  • Questions & Answers
    • Communication of HCEI by Firms to Payors Regarding Approved Drugs
    • Communications by Firms to Payors Regarding Investigational Drugs and Devices

BREAK -

Session #: 5
Duration: 30 minutes
Learning Objectives: This session will discuss the guidance "Medical Product Communications That Are Consistent With the FDA-Required Labeling " which explains the FDA's current thinking about firms' medical product communications that include data and information that are not contained in their products' FDA-required labeling, but that concern the approved or cleared uses of their products.
  • Introduction
  • Background
  • Questions & Answers

Session #: 6
Duration: 30 minutes
Learning Objectives: This session will discuss comments from industry, health care providers, health care insurers and other concerned parties. The latest legal considerations, decisions and conclusions will be discussed as well as future expectations for off-label promotion of medical products.
  • Comments from Industry
  • Comments from Health Care Providers
  • Comments from Health Care Insurers
  • Legal Considerations
  • Future Expectations

Q&A

Learning Objectives:
  • Context of the Off-Label Promotion Decisions
  • Patients' Expectations
  • FDA Position
  • Industry Position
  • Legal Considerations
  • FDA Guidance Documents
  • Current State of the Decision and Expectations for the Future

Who Will Benefit:
  • Quality Managers
  • Quality Engineers
  • Regulatory Affairs
  • Regulatory Attorneys
  • Doctors
  • Health Insurance
  • Small Business Owners
  • GxP
  • Consultants
  • Quality VPs
  • IT VPs
  • Lab Directors
  • Scientists
  • FDA Investigators
  • Other Regulatory Agency Investigators
  • Nurses
  • First Amendment Lawyers
  • Fifth Amendment Lawyers


Speaker Profile
Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital. Positions include Chief Compliance Officer, http://morflearning.com/angelabazigos/, Director of QA and MIS Director. Co-authored & prototyped 21 CFR 11 guidance with FDA. Co-authored Computerized Systems in Clinical Research w/ FDA & DIA http://www1.diahome.org/~/media/4FA562336EBD46C58CDC43A8B7773095.ashxPatent on speeding up software compliancehttps://www.google.com/patents/US8266578 . Recently quoted in Wall Street Journal for using training to bring regulatory compliance to the Boardroomhttp://blogs.wsj.com/riskandcompliance/2015/07/24/using-training-to-bring-compliance-to-boardrooms/ includes training for Society of Quality Assurance. Comments / collaborates with FDA on new guidance documents. Former President of Pacific Regional Chapter of Society of Quality Assurance. Stanford’s Who’s Who for LifeSciences: http://www.stanfordwhoswho.com/Angela.Bazigos.7144112.html#overview.




Your Recently Viewed Webinars

Payment Methods

Contact Us

NetZealous LLC,
161 Mission Falls Lane, Suite 216,
Fremont, CA 94539, USA.

Information

  Refund Policy
  +1-800-447-9407
  support@compliance4All.com