Safety Data Exchange Agreements (SDEA) in Pharmacovigilance: training course +workshop

  • 1° EDITION: 24 September 2024
  • 2° EDITION: 6 March 2025
  • Online
  • Italian

Training overview

Effective management of pharmacovigilance aspects in commercial agreements is essential for all parties involved and ensures compliance with drug regulatory requirements. Therefore, commercial agreements between companies must be set up considering possible interactions with pharmacovigilance and possibly supplemented by agreements (commonly: “Safety Data Exchange Agreement”) that define the Pharmacovigilance obligations of the contracting Companies.

The training course “Safety Data Exchange Agreements (SDEA) in Pharmacovigilance” is of interest to personnel involved in the negotiation, drafting and management of pharmacovigilance agreements of various types (e.g., co-marketing, distribution, licensing, services), but also to those working in regulatory affairs, marketing, and legal departments. This seminar, with an interactive focus and including a workshop to put the theoretical concepts explained into practice, addresses the main regulatory requirements for pharmacovigilance by indicating the main terms to be included in different types of agreements, in order to ensure regulatory compliance with a practical approach to drafting and maintaining such agreements.

Would you like to participate, but you’re not available on this date?
The course will be provided again:

  • September 24th 2024
  • March 6th 2025

(*) Contact us via email or phone to enroll.

Interested in Pharmacovigilance training?

Key points of the training

  • Distinguish the main types of commercial agreements
  • Know the updated reference legislation on contract management in Pharmacovigilance
  • Identify formats and contents of the SDEA
  • Write a SDEA in accordance with regulatory requirements
  • Practical implications in the management of SDEA
Course Structure

09:30 – 12:30 MORNING SESSION

  • Contractual agreements: definitions and relevant legislation:
    • Types of agreements
    • Definitions
    • GVP References
  • Contents of the Safety Data Exchange Agreement:
    • Background
    • Technical clauses and common clauses
    • Templates
    • Attachments
  • Management of SDEAs:
    • Tracking system
    • Verification of commitments made
  • Q&A Session
  • Interactive Session:
    • Setting up a pharmacovigilance agreement: each participant will set up a specific type of pharmacovigilance agreement; the drafts will then be reviewed and commented on with all participants, highlighting any errors made and suggesting optimal alternative solutions.
  • Final discussion and conclusion of the day

Personnel involved in the areas of Pharmacovigilance (PV Manager, Drug Safety Manager, QPPV, Safety Officers, PVQA), Regulatory Affairs, Legal, Marketing.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.


Patrizia Rotunno

Patrizia Rotunno

Pharmacovigilance Consultant

Graduated in Chemistry and Pharmaceutical Technologies at the University of Milan in 1998, she began her working career in the field of Regulatory Affairs and Pharmaceutical Technological Development; she has been involved in Pharmacovigilance for 18 years and since 2004 she has been Head of Pharmacovigilance at AIFA and the European QPPV of DOC Generici S.r.l., where she set up and managed the company pharmacovigilance system by directly intervening in all processes concerning pharmacovigilance including the drafting of numerous Risk Management Plan. She currently carries out consultancy activities in Pharmacovigilance. She has attended and still participates in refresher courses in Italy and abroad and she is a lecturer at the Master’s in Regulatory Disciplines at the University of Pavia and at the second-level Master’s in Pharmacovigilance at the University of Milan. She is member of the Pharmacovigilance group of AFI and of the Society of Applied Pharmacological Sciences.

Register now

Early Bird 10%
Within 2 months before the start of the training
Early Bird 5%
Within 1 month before the start of the training
Full price


Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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