EU Road to reach interoperability across regulatory systems:

Are you in step with the new EMA standard and regulatory systems?

This October 26th from 11.30 AM to 12.30 PM (CET) join us for a very special free online event!

What will I learn?

Regulators push to establish a high level of interoperability across global regulatory and healthcare communities. First step toward to interoperability of regulatory information systems is definition of standards for data and systems. The EMA started its multi-year programme which defines a Master Data Management (MDM) strategy for the use of medicinal product data specifically related to Substance, Product, Organisation and Referential (SPOR) data. SPOR services supports the implementation of ISO IDMP standards for the identification of medicinal products standards in the EU / EEA.
Recently EMA accelerated also implementation of its Target Operating Model: the new DADI forms enabling structured data submissions and replacing the former electronic Application Form (eAF). DADI will be implemented for CAPs in October 2022 and be mandatory starting from September 2023 for NPs, MRPs and DCPs.
The EMA is fast moving to establish well integrated and interoperable regulatory information systems. This environment represents a continuous challenge for pharmaceutical companies shifting and adapting their operations and systems to face the new regulatory trends.
Make clear where your organization is, determine your goal and set an agile project plan to fast adapt organization (quality system, documents and data management) and infrastructure for a data management ready for IDMP new requirements and newly established interoperable regulatory information systems.

Main topic agenda

  • check mark Interoperability across regulatory systems: the ISO IDMP framework
  • check mark EMA implementation roadmap and SPOR data management services
  • check mark Q&A
Hosted by
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Introducing the Team

Abbate

Francesco Abbate
Speaker

Senior Regulatory Affairs Consultant

Passionate about Regulatory Affairs since 2014 with a broad experience within commercial affiliates, manufacturing plants and consultancy within Pharma&Biotech industry.
RA Professional mainly focused on MAs lifecycle management, CMC, Technology Transfers and Regulatory Compliance. I'm currently progressing into the Project Management world and I'm curious to discover it entirely. Self-motivated, reliable and always ready to dive into new challenges!
Polello

Barbara Polello
Speaker

Pharmacovigilance Compliance Expert

Experienced professional with a strong background in Pharmacovigilance and passionate about the safety in drug development and post-marketing use within Pharma industry. At the time, I'm responsible for the quality and compliance of PV deliverables, and I'm a PV lead auditor. Reliable, and with excellent communication and time management skills to manage multiple projects at any one time!
Cinquanta

Paola Cinquanta
Moderator

Regulatory Affair Operations Manager

Paola Cinquanta has more than 10 years’ experience long career in Regulatory Affairs for highly regulated products. Graduated at the University of Milan with a degree in Pharmaceutical Biotechnology and a Specialization in Regulatory Affairs, she spent her career in several pharmaceutical companies ranging from generic drugs and biosimilars development, to innovative biopharmaceutical industry with role of Project Manager. Paola possesses extensive experience in Regulatory Affairs and wide knowledge of MAA request via Centralized Procedure/MRP as well as NDA/BLA and NDS; ODD, preparation of CTA/IMPDs/INDs for Ph 1-3 studies; pre-/post registration of ODAs and PIPs, PSURs, etc.

Her specialty is Oncology, GvHD; Transplantation; Anesthesia, Pain, CNS and Anti-Infectives.

She joined PQE in 2018 as an Executive Consultant, then in 2022 she has been appointed Regulatory Affairs Operations Manager and Senior Associate Partner, coordinating the Regulatory Affairs Teams at global level.