Introduzione
Gaining marketing authorisation is a critical milestone for any medicinal product—and mastering the Marketing Authorisation Application (MAA) process is essential to achieve it. This course offers a hands-on, practical approach to navigating MAA procedures across three key markets: the EU, UK, and US.
Through real-world insights, we’ll explore how to prepare a compliant and compelling application, avoid common regulatory pitfalls, and select the right pathway depending on product type—whether generic, originator, orphan, or paediatric.
With a special focus on EU procedures, you’ll gain a clear roadmap from pre-submission planning to post-submission follow-up. You’ll also understand the key differences when applying in the UK and US, helping you streamline your strategy and timelines for global market access.
- Diving into the MAA regulatory legal framework in the EU, US and UK:
- Overview of regulatory authorities: Food and Drug Administration (FDA), European Medicines Agency (EMA) and Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.
- Legal basis, guidelines, and laws governing EMA marketing authorizations. The main differences compared to the UK and US ones to be kept in mind.
- Requirements and relevant documentation for applying in the EU. The main differences compared to the UK and US ones to be kept in mind.
- Overview of the different MAA procedures in the EU: standard vs. non-standard procedures, their differences and areas of application.
- Special cases: Different types of medicinal product.
- Understand the steps pre, during and after the submission in order to well plan the medicinal product entry into the market:
- Process and timelines for the Authority’s review process, including eventual responses to questions.
- Touchbase on the platforms needed to be set before an MAA application.
Regulatory Affairs Officers, Specialists and Project Managers both on Operations and Strategy focus.
Participant experience
This course is aimed at new professionals in regulatory affairs who are starting or changing their careers.
No prior experience is required. Some basic knowledge is welcome to enrich the discussion.
Interactive presentation with quizzes and case studies. Questions are welcome during the workshop.
Docente/i
Fernanda Manhães
Fernanda has a PharmD degree, a Master in Health Economics and Pharmacoeconomics and a course of Leadership in Innovation from the Massachusetts Institute of Technology (MIT). With her more than 10 years of experience in Regulatory Affairs, she has assisted many pharmaceutical companies in all stages of growth, from start-ups to established multinationals, with the global regulatory strategy to filings in Europe, US and Brazil. Her experience ranges from clinical trials to marketing authorizations and post-authorizations including chemicals, biologics, and medical devices/combination products.
Online Training – 2 modules
Module 1 | 21 April 2026 from 2:00 pm to 5:30 pm CEST
Module 2 | 23 April 2026 from 2:00 pm to 5:30 pm CEST
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 905,00* (until 31 March 2026)
Ordinary: € 1.095,00*
Freelance – Individual – Academy – Public Administration: € 640,00*
* for Italian companies: +22% VAT
The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
