Pharmaceutical Promotion
Developing Processes to Lower Risk
Overview
- 2 day seminar
- For pharmaceutical company employees; admission of other attendees only on invitation by Pharmiceutics LLC
- Instructor: Joseph E. McMillian, Heartland Compliance Services LLC
Target Audience
- Regulatory professionals
- Marketing and sales professionals
- Professionals involved in the development and/or implementation of promotional marketing materials
- Advertising agency professionals
- Promotional auditors and other QA professionals
- Law department members
Curriculum
The curriculum of this seminar is intended to provide guidance to those directly involved in pharmaceutical advertising and promotion in how to set up programs which will lessen regulatory risk to their companies. In addition, this program will present the general must-knows of complying with pharmaceutical promotional regulations from a global, EU and US perspective, respectively.
To stimulate dialogue and open discussion, the number of participants in this seminar will be limited.
Information on our outstanding instructor is available at www.heartlandCS.net
Brief Program Outline
The following outline is a sample only; the actual seminar agenda may differ slightly.
Day 1
Definitions and Rules for pharmaceutical promotion
- Why Promotional Compliance is Important
- Labeling: the basis for promotion
- The shifting rules of national boundaries
The risks associated with various types of promotion
- Printed and internet media
- Sales presentations
- Drug sampling
- Conventions and medical congresses
- Scientific programs and publications
Breakout group discussion: promotion, education and the sharing of scientific information
- Separating promotion from the disclosure of new scientific information
- Identifying activities that are high risk and those which are low risk
Day 2
Are there “safe harbors” for promotion?
- Defining a promotional “safe harbor”
- Are all countries the same?
Who has the responsibility for compliance?
- Many people are involved
- Identifying specific responsibilities
How to lower risk
- The steps to take in identifying and mitigating risk
How to assess your current risk
- Methods to identify promotional risk across regions and countries
Mitigating risk
- The roles of SOPs, training, monitoring and corrective actions
Suggestions for developing practical policies, SOPs and training programs
- How complex should they be?
- How do they interrelate?
Monitoring compliance within your company
- How complex should it be?
- The risks associated with each type of monitoring program