Developed by European regulatory professionals for regulatory professionals operating in Europe’s quickly changing and uncertain regulatory environment, RAPS European workshops bring together leading experts in the medical device, IVD and pharmaceutical industries.

Join us for one of the workshops below to gain insight into some of the most urgent and crucial issues facing regulators, manufacturers and regulatory professionals working with healthcare products for the European market.

Regulatory Considerations for Advanced Therapies & RNA-based Therapeutics

Regulatory Considerations for Advanced Therapies & RNA-Based Therapeutics

Thursday, 9 December 2021, 14:00 –
Friday, 10 December 2021, 18:00 Central European Time

Early Bird Deadline: 8 November 2021

Advanced therapies are one of the fastest growing sectors in the biopharmaceutical industry. A myriad of new and innovative technologies are being developed to treat human diseases which are often rare or ultra-rare. However, these complex technologies entail regulatory challenges at any stage of the product development. Regulatory requirements for quality, CMC, preclinical and clinical research that may differ by jurisdiction add to the challenges of product development.

The first day of the workshop will provide an overview of the regulatory landscape for product development considerations and clinical trial conduct in the European Union and the United States. This overview will include discussion of opportunities to interact with regulators and utilize available regulatory tools. The second day will discuss regulator considerations for specific product types based on case studies.

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