FEATURED TOPICS:

  • THE REGULATORY FRAMEWORK OF INNOVATIVE THERAPIES

This session will introduce the regulatory landscape and will discuss hands on experiences of registration process related to Novel Therapies – ATMPs. Due to their high complexity and multiple potential, ATMPs are subject to continuously evolving regulatory requirements. Regulatory professionals will share their experience on the registration synergies needed for accelerating the availability of these therapies on the market. 
Case studies and keynote presentations followed by a final panel discussion with the involvement of participants.

  • THE REGULATORY LANDSCAPE AFTER BREXIT

Brexit affected significantly many activities in the pharmaceutical and lifescience industry, such as marketing authorisations and drug approval procedures, rules on Good Manufacturing Practice (GMP), pharmacovigilance and clinical trials. A MHRA expert has been invited to present the main impacts of Brexit implementation on regulatory and marketing, at four months from come into force.
Q&A session will follow.

  • DRUG-DEVICE COMBINATION: An evolving global Regulatory scenario

The manufacturers/MAH are required to fully understand and apply the specific requirements in each country 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 share their experience during keynote presentations and a panel discussion with the involvement of participants.

  • EXTRA EU AND EMERGING MARKETS: REGULATORY ASPECTS AND CHALLENGES

Emerging markets have complex healthcare systems under rapid evolution, requiring 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 participants.

  • THE PHARMA DIGITALIZATION

The digital transformation is affecting the whole product lifecycle, from R&D to product supply and patient care, bringing patients and their quality of life to the center of the pharma business. In this session Regulatory Experts from leading industries will share their point of view about digital regulatory models and digitalization in therapies.
Keynote presentations followed by a final panel discussion with participants.

The Workshop

This year the Forum will be enriched with half day of workshop on May 13. It will be a perfect occasion to address the more practical aspects of some topics presented and discussed during the first day with the precious contribution of experts in the field.

FEATURED TOPICS:

  • THE ICH Q12 GUIDELINE: CHALLENGES AND OPPORTUNITIES
    The key points of the guideline will be presented and discussed, together with the potential benefits for the MAH of using the tools and enablers described in ICH Q12 guideline, with reference to the current EU legal framework.
    The presentation will be followed by a final panel discussion with the involvement of participants.

  • NITROSAMINES ASSESSMENT
    Regulatory experts will share their experience about the implementation of the assessment of Nitrosamines impurities in the finished product dossier and the related regulatory impacts with the different authorities.
    The presentation will be followed by a final panel discussion with the involvement of participants.

  • PRICING AND REIMBURSEMENT OF MEDICINAL PRODUCTS IN ITALY
    The new AIFA guideline on prices and reimbursement will be discussed, with a focus on the new requirements compared with the last version.
    The presentation will be followed by a final panel discussion with the involvement of participants.

  • ELECTRONIC COMMON TECHNICAL DOCUMENT – eCTD
    The eCTD is now an established digital format that pharmaceutical companies adopt for the registration of drugs, as recommended by the International Conference on Harmonisation (ICH). The speakers will share their experiences illustrating the advantages and challenges they have faced in the management of this document.
    The presentation will be followed by a final panel discussion with the involvement of participants.

WHO SHOULD ATTEND?

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

WHY ATTEND?

The involvement of European Regulatory Affairs experts, opinions leaders, regulatory body representatives, new IT technologies suppliers and consultants from Italy and Europe, makes this event highly appreciated by Pharma, Biotech, Medical Device companies and also by the IT Suppliers, for the great opportunity to meet professionals and get and share technical knowledge and strategies about the future of the Regulatory Affairs in Europe.

FORMAT

The Congress will offer several sessions of oral talks about hot topics and case studies, including interactive Q&A and round-table sessions with the involvement of all the participants. Speakers and Delegates will be given dedicated time to networking and sharing of experiences about emerging Markets, strategies and new trends of Regulatory Affairs.

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