Introduzione

A Marketing Authorisation Application (MAA) provides comprehensive information about a medicinal product, enabling 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.

The MAA is the most important part of placing a medicine on the market. Failure to submit a compliant MAA can have undesirable consequences.

Starting from the legal framework, you will learn about the EU, US and UK procedures for obtaining marketing authorizations for pharmaceutical products, the documentation required in support of an application, with a brief introduction to the clinical studies which may support an application. You will become aware of the different types of medicinal products such as generics, originators, orphan drugs and pediatrics, and what are the differences in terms of documentation to be presented.

Focusing on the EU, we will analyze the pre-submission steps as well as the post-submission steps needed to not lose track of the timelines, which are necessary to plan the successful entry of your product in the market.

About UK and US, the must and the main differences with the EU steps will be analysed.

– Diving into the MAA regulatory legal framework in 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.

– Explain the EU non-standard procedures for marketing authorisations and their differences

– 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 in 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
1-2 years of experience is desired to enrich the discussion.

Interactive presentation with quizzes and case studies.

Docente/i

Info

Fernanda Manhães

PharmD, MSc, Independent Regulatory Affairs Consultant – REGX Solutions

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.

Durata e Informazioni utili
Quote Iscrizione

Online Training – 2 modules

Module 1 | 05 November 2024 from 02:00 pm to 06:00 pm CET
Module 2 | 07 November 2024 from 02:00 pm to 06:00 pm CET

After the registration, 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 18 October 2024)

Ordinary: € 1095,00*

Freelance – Individual – Academy – Public Administration**: € 640,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Individual – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.