Module 12
Regulatory Considerations & Strategies
Regulatory implementation of a CCDS/CCSI can be challenging, in particular when the product is already marketed and the company's proposed labeling conflicts with local class labeling (formal or informal). Directions to affiliates have to be realistic and sensitive, and companies need to understand the viewpoints of regulatory authorities. An excellent analysis of the local regulatory situation is paramount to avoid tilting at windmills. Occasionally, a good "paper trail" demonstrating appropriate efforts is all that can be achieved.
Curriculum topics of this module include:
- Labeling harmonization: Comparison of viewpoints and objectives of companies and regulatory authorities
- How to make sure we understand the position of a local regulatory agency
- Considerations and strategies: Regulatory agency rejects a proposed safety change
- Considerations and strategies: Arguing against a change requested by a regulatory agency
- The role of local affiliate staff in "negotiating" with regulatory authorities