AGENDA 2021

MAY 12, 2021

  Introduction
Raffaella Pandini,
Regulatory Affairs Operational Manager at Pharma D&S
SESSION I – 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.
Confirmed speakers:
  Raffaele Cerbini, Executive Medical Director
  Patrizia Ciavatta, Global Regulatory Affairs Executive Director at Angelini
  Federica Grotti, Head of Regulatory Affairs at Pfizer (TBC)
SESSION II – 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.
SESSION III – 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.
  Invited speakers (tbc)
SESSION IV – 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.
Confirmed speakers:
  Stefano Accorsi, Head of Regulatory Affairs “Emerging Countries and IMDD” at Chiesi Farmaceutici
  Alessandra Leone, Global CMC Senior Manager – PTx at Pfizer
SESSION V – 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.
Confirmed speakers:
  Frank Dickert, Senior Business Consultant at EXTEDO
  Priya Tiwari, Associate Director Global Regulatory Affairs – Digital Health, Combination Products and Medical Devices at Biogen
  Roberto Ascione, CEO at Healthware Group

 

MAY 13, 2021

SESSION VI – 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.
Confirmed speaker:
  Jean Louis Robert, EU topic leader for Life Cycle Management ICH Q12
SESSION VII – 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.
Confirmed speaker:

  Raffaella Pandini, Regulatory Affairs Operational Manager at Pharma D&S
SESSION VIII – 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.
Confirmed speaker:
  Alessandra Perini, Avv., LL.M. (UCL), In-house Counsel, Pharmaceutical Legal Expert
SESSION IX – 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.
  Pharma D&S Representative

 

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