Introduction

For anyone interested in developing for and registering products in USA, this course will give all the required information about how to set-up your product development and successfully achieve registration with FDA.

To whom it may concern

• Regulatory Affairs Manager, Officer and Specialist
• Quality Manager
• Development Pharmacist
• Pharmacovigilance Manager
• Project Manager

working for pharmaceutical company and CROs whit specific interest in FDA regulation.

Type of Training

Theoretical explanation of US requirements, practical tips and tricks and use case explanation and example on how to develop and register your product with FDA and Q&A sessions.

Lecturer’s Bio

Lidia Cánovas, Director of Regulatory Affairs, Asphalion S.L.
Lidia has a Pharmacy and MBA degree.
She has fifteen years overall experience in pharmaceutical industry, ten years as Regulatory Affairs Director and four years as Vice-Director for Research and Development. She has been working at Asphalion for ten years
as General Manager and Director of Regulatory Affairs. As director of Regulatory Affairs at Asphalion, 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 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 during 10 years. He is member of the American Society of Gene & Cell Therapy (ASGCT), the Licensing Executives Society (LES) and the Regulatory Affairs Professionals Society – RAPS (certified 1994).

Participants Experience

Basic regulatory knowledge would be preferred.

At the end of the training, you will be able to:

Understand the US regulatory landscape and requirements. Be able to develop and register your products in US, by understanding the Regulatory environment

To register for the course you can fill in and send the registration form or directly resgister online:

http://fda-regulatory-2019.lsacademyevents.it/orders/new 

Registration fees:

Early bird: 1470,00€* (until 08/09/2019)

Ordinary: 1680,00€*

Freelance – Accademy – Public Administration: 790,00€*

*For Italian companies: +22% VAT

The fees includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.

For more information:

e-mail: [email protected]

telephone: (+39)035.515684

Download the program and registration