Enabling organizations to ensure compliance with ever-changing regulatory obligations, manage risk, increase efficiency, and produce better business results is not an easy task. That is why we propose a series of sessions to encourage all sizes organizations to have a defined regulatory strategy since development phases, providing examples of regulatory procedures, analysis of legislation, as well as capabilities to apply this knowledge in order to help their organizations to make informed business decisions.

Session 6: “Nonclinical and regulatory considerations to successfully get your molecule into the clinic – some thoughts”. Within this session we will talk about:

Begin developing your regulatory strategy when you move from discovery to developing or when in-licensing

Non clinical needs for new product development

Regulatory needs for early-stage companies/researchers

Medicinal product development regulatory interactions

The format of these meetups will be a theoretical part, accompanied by real experiences