European Regulatory Affairs Forum

Topics of the European Regulatory Affairs 2022:

  • INNOVATIVE THERAPIES: THE REGULATORY FRAMEWORK

The session will be focused on the regulatory landscape of innovative medicines. To ensure quick access to new medicines for patients, it is essential for Europe to have a regulatory environment that understands and embraces innovation. Experts from companies will share experiences about the regulatory strategies and tools that can allow early approval of Innovative Medicines.
Case studies and keynote presentations followed by a final panel discussion with the involvement of all delegates.

  • DRUG-DEVICE COMBINATION PRODUCTS: MDR IMPLEMENTATION

In EU, the manufacturers/MAH are required to fully apply to specific requirements in order to ensure a timely and accurate market access of new combination products, a market that is constantly growing over years. Regulatory Affairs experts from companies will give an overview on the EU requirements and their impact on the submission process of combination products.
Keynote presentations followed by a final panel discussion with the involvement of all delegates.

  • EXTRA EU MARKETS: REGULATORY ASPECTS AND CHALLENGES

Extra EU markets as Brasil and MENA (Middle East and North Africa) markets require a constant effort to ensure an effective market access. Experts will share their regulatory experience, discussing the opportunities and challenges posed by these countries.
Keynote presentations followed by a final panel discussion with the involvement of all delegates.

  • THE PHARMA DIGITALIZATION

The digital transformation is affecting the whole product life cycle, from R&D to product supply. In this session Regulatory Experts from leading industries will share experiences about the digitalization process with focus on the Regulatory Information Management Systems and the IDPM implementation.
Keynote presentations followed by a final panel discussion with the involvement of all delegates.

  • THE CLINICAL TRIAL REGULATION

The implementation of EU CTR n° 536/2014 has become complete with the go live (31 Jan 2022) of the CTIS (Clinical Trials Information System) enabling clinical trial application submission through a single informatic system within the EU. The experts will share the main changes introduced by this implementation and their effects on the regulatory department activities.
Keynote presentations followed by a final panel discussion with the involvement of all delegates.

The Workshop

The Forum will be enriched with half a day of workshop on May 13th. It will be a perfect occasion to address some practical aspects, thanks to the precious contribution of experts in the field sharing their own “hands-on” experience.

FEATURED TOPICS:

  • REGULATORY FRAMEWORK FOR BIOLOGICAL PRODUCTS

The session aims to give an overview on the regulatory requirements (EMA/FDA/AIFA) applied to biological medicinal products, with a special focus on the drug substance and the drug product.
Experts from leading companies will share their experience with different Health Authorities.
Presentation followed by a final Q&A with the involvement of all delegates.

  • PRICING AND REIMBURSEMENT OF MEDICINAL PRODUCTS IN ITALY

The session is dedicated to an in-depth analysis of the pricing and reimbursement system in Italy, useful for understanding deeply the operational details for companies interested to market their product in Italy.
Presentation followed by a final Q&A with the involvement of all delegates.

  • EDUCATIONAL MATERIALS – THE ITALIAN PROCESS FOR APPROVAL

Interesting topic with a technical presentation aimed at exploring the operational details required by the Italian Medicines Agency (AIFA) for the approval of the educational materials related to the products authorized and distributed on the Italian market.
Presentation followed by a final panel discussion with the involvement of all delegates.

  • NATIONAL MONITORING REGISTERS OF MEDICINAL PRODUCTS

The pharma company review of AIFA monitoring registers is a crucial step in the assessment on the eligibility of the patients for a specific therapy inside the reimbursement access. During the presentation, the experts will give an overview about the main steps of this process and the attention to be paid in reviewing it.
Presentation followed by a final panel discussion with the involvement of all delegates.

WHO SHOULD ATTEND?

• Regulatory Affairs VP, Directors, Manager, Head of Pharma, Biotech and Medical Device Industries
• Regulatory Bodies
• Technology IT Suppliers

WHY ATTEND?

The Forum will feature several sessions on the hot topics of the moment, with case studies, interactive Q&A moments and round tables with the involvement of all the delegates: a great opportunity to understand different point of views and expertise. The involvement of European Regulatory Affairs experts, opinions leaders, regulatory body representatives, new technologies suppliers and consultants from all over Europe, makes this a must-go event for Pharma, Biotech, Medical Device companies and for IT Suppliers.

FORMAT

International experts will be discussing hot topics and case studies, including interactive Q&A and round tables with the involvement of all the participants.
Speakers and delegates will share their experiences on emerging markets, strategies and new trends in Regulatory Affairs.

Via Dei Pratoni, 16 - 50018 Scandicci (FI)
Tel. (+39) 055 0465181
E-mail: info@pharmaeducationcenter.it