90-Minute Advantage - Course Outlines - New Regulations and Guidelines

Understand how state regulations targeted toward promotion have had a chilling effect on conducting market research in certain states
Become familiar with the American Medical Association's Prescribing Data Restriction Program (PDRP)
Know the key industry guidelines, association guidelines, and federal HIPAA regulations, and how they impact market research
Become familiar with the various avenues to product approval (NDA, ANDA, 505(b)(2), and other regulatory jargon)

Background on how and why state regulations overseeing pharmaceutical activities have intensified
Review of key state regulations on payments to physicians
1. States that have passed legislation limiting "gifts" to physicians, including honoraria
2. State reporting requirements
3. In-depth discussion of Vermont and California
4. Impact on market research activities in those states
5. A look to the future, including a discussion of the state licensing of pharmaceutical sales representatives and the impact on market research
American Medical Association's Prescribing Data Restriction Program
1. Scope of the program
2. Impact on market research
3. New Hampshire legislation following PDRP and possible trends
Other guidelines
1. PhRMA guidelines
2. Other AMA guidelines
3. Office of Inspector General (OIG) guidelines
4. AdvaMed (if devices are of interest)
Health Insurance Portability and Accountability Act (HIPAA)
1. Scope of act relevant to market research
2. Impact on market research
Regulatory alphabet soup of product approvals
1. Difference between NDA and ANDA
2. Difference between PMA and 510(k)
3. "Paragraph IV" challenge
4. Difference between a BLA and NDA
5. 505 (b) (2) applications

Each participant will receive a 2-sided laminated card with key learnings from the course

Leslie Goldberg, Executive Vice President

666 Godwin Avenue, Suite 320
Midland Park, NJ 07432
p: 201-670-7722 ext. 205
f: 201-670-8707
lgoldberg@advantageh.com