For anyone interested in developing and registering products in the USA, this online training course will give all the required information about how to set up your product development and successfully get an FDA registration approval.
The course is aimed at:
working for pharmaceutical companies and CROs whit specific interest in FDA regulation.
Participants’ Experience: Basic regulatory knowledge would be preferred
Type of Training: Online interactive training. Theorical explanation of US regulatory framework for drug development, practical tips and tricks for communications with the FDA and examples on how to develop and register your product with the FDA, including parallel development for the EU.
Lidia Cánovas, Director of Regulatory Affairs, Asphalion S.L.
Lidia has both a Pharmacy and an MBA degree.
She has more than fifteen years overall experience in the pharmaceutical industry, most of which as a Regulatory Affairs Director, but she has also taken the role of vice director for Research and Development. She has been working at Asphalion for ten years as a General Manager and Director of Regulatory Affairs. In this second role, Lidia is responsible for the overall quality of the Regulatory and Scientific services that Asphalion provides to a large number of international and national clients.
Bruce Thompson, Principal at Reguliance
Bruce is an independent consultant with over 20 years’ experience in the pharmaceutical and biotech industries, possessing practical skills in the details of product development planning, regulatory strategy, and project management. He is the Principal of Reguliance, which he founded in 2002. He has previous experience in the pharmaceutical industry as Managing Director, Director of Regulatory Affairs and Acting Director for US Regulatory Affairs for several companies for 10 years. He is a member of the American Society of Gene & Cell Therapy (ASGCT), the Licensing Executives Society (LES) and the Regulatory Affairs Professionals Society – RAPS (certified 1994).
At the end of the training, you will be able to:
Understand communication programmes with the FDA during development, have a clear overview of FDA accelerated programmes and be able to identify the main differences between EU and US in terms of drug development.
Early bird: 890,00€* (until October 21st, 2020)
Freelance – Academy – Public Administration**: 540,00€*
*For Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent via e-mail after completing the training.
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