The audience will get an overview of the current global regulatory landscape for cannabis- and plant-derived pharmaceutical products that currently differ from one country to another even through the EU. They will understand the current challenges that they will face if they are working on such projects. These challenges include regulatory challenges in terms of regional requirements in terms of acceptable claims, CMC information, clinical trial designs and level of evidence required. In addition, this area is changing rapidly and therefore, such regulatory affairs professionals should be able to expect the time of the change and pre-plan for mitigating actions. The session will include some case studies that reflect the challenges and provide lessons learned from each sucess and failure story. Therefore, they can apply similar principles during their current or next projects.
Describe the current global regulatory environment for plant- and cannabis-derived pharmaceutical products and its challenges.
Gain more tools that should be considered while planning and executing a regulatory strategy for global pharmaceutical products derived from plants.
Apply the lessons learned from success and failure stories.