Introduzione
The Marketing Authorisation Application (MAA) is the most important part of placing medicine on the market. Indeed, an MAA provides comprehensive information about the medicinal product and enables regulatory authorities to assess its quality, safety and efficacy, and to evaluate the ability of the future Marketing Authorisation Holder (MAH) to ensure and monitor a sustainable risk-benefit balance.
Failure to submit a compliant MAA to the regulatory authorities usually has undesirable consequences for a pharmaceutical company.
Starting with the regulatory framework, this course will teach you about the different types of medicines, such as generic, originator, orphan and paediatric, and the different MAA procedures (and supporting documentation) for bringing medicines to the EU, US and UK markets.
Focusing on the EU, we will analyse the pre-submission and post-submission steps required to keep track of the timelines necessary to plan your product's successful market entry. For the UK and US, we will analyse the requirements and key differences from the EU steps.
- 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.
Regulatory Affairs Officers, Specialists and Project Managers both on Operations and Strategy focus.
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 | 14 April 2025 from 2:00 pm to 5:30 pm CEST
Module 2 | 15 April 2025 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 24 March 2025)
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.
Registrati
Barbara Rossi
Training & Quality Manager
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.