Online registration for this comprehensive forum ended Tuesday, 10 August. Please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or raps@raps.org for other registration options.
Knowing how to develop an effective global regulatory strategy is an essential skill for regulatory professionals. Successful global regulatory strategies maximize commercial opportunities for healthcare product manufacturers while minimizing company risk. By engaging in in-depth analysis and workgroup collaboration in the highly interactive Regulatory Strategy Forum, you will gain vital insight on proven methods to enhance your strategy and further your product’s success.
Leading experts from the pharmaceutical and biologics industry will direct you in engaging discussions and interactive case study analysis that will give you the knowledge and tools you need to develop a successful global regulatory strategy.
Examine global differences in submission formats and filing strategies as well as the critical importance of systematically monitoring and revising your strategy. Principal regulatory strategy subjects to be discussed include:
- Regulatory standards
- Risk management tools
- Essential elements of a global Regulatory Strategy Document (RSD) and Target Product Profile (TPP)
Learning Objectives
- Define the role of regulatory strategy in product development and lifecycle management including who should be involved in setting the strategy as well as mechanisms for researching requirements and ensuring your documentation is up-to-date
- Outline the major components of a global Regulatory Strategy Document (RSD) and the content that should be included in each section
- Identify specific regulatory issues related to the development of your drug or biologic and corresponding target markets as well as how to mitigate regulatory risk through effective management of the strategy plan
Target Audience
Mid-level regulatory professionals from industry and consulting firms with international submission experience.
RAPS Atlanta Chapter Event on 16 August:
Hot Topics in Pharmaceutical Regulations in Europe and the US
While in town, plan to attend the local RAPS Atlanta Chapter networking and Pharma hot topics event on Monday evening, 16 August.
Learn more and register today »