Event titled “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” will take place in Madrid on 10th October

The PM Holding group of companies including CROS NT, Arithmos, and seQure are excited to announce a Regulatory Day workshop, a unique event in collaboration with Oracle and Asphalion that focuses on the product development journey through post-marketing, and compares the FDA and EMA regulatory landscapes. The workshop aims to not only provide expert sessions on pre- and post-market regulatory topics, but also engage stakeholders, KOLs and industry professionals in the discussion on where the market is moving.


Who is hosting this event? A group of international companies specialized in life sciences, healthcare and clinical research with solid experience in the regulatory field and direct contact with European and American regulatory authorities.

  • PM Holding is a group of companies providing an end-to-end service of added value to clinical research through:
    • CROS NT: biometrics specialized CRO
    • seQure: Safety, QA and Regulatory experts;
    • Arithmos, innovative technology and solutions;
  • Oracle is the #1 provider of business software, with a broad portfolio of solutions for companies of all sizes. It boasts 430,000 customers in 175 countries.
  • Asphalion is an International Scientific and Regulatory Affairs consultancy, with offices in Barcelona, Madrid, Amsterdam, and Munich. It provides worldwide support, offering services for Drug Development and Regulatory Affairs to Pharma, Biotech and Medical Devices companies.


The focus of Regulatory Day is “Breaking Down The Silos: Product Development Journey through Post-Marketing: EMA vs FDA” and the speakers will guide the participants through the labyrinth of European and American regulations, procedures, requirements, and submission format.

The event agenda features the following topics:

  • Integrated summaries;
  • Pre- and post-market safety;
  • Digital Transformation in Clinical Trials.

The detailed agenda can be downloaded here.


The immersive event will take place on the 10th of October at the Oracle office in Madrid, capital of Spain and a centrally located city strategically situated near important pharmaceutical and biotech hubs.

The event participants can reach the venue from the center of the city by metro or by taxi.


The participation in the event is free of charge and can be done following this link.

Every pass includes:

  • Participation in scientific sessions;
  • Participation in the roundtable discussionsr;
  • Coffee breaks and lunch;
  • Access to the presentation material post-event.


In case of questions, get in touch with us via email at info@sequrelifesciences.com.

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