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Virtual

Sep 22, 2026 9:00 AM - Sep 24, 2026 1:30 PM

(Central Europe Standard Time)

EU Risk Management Plan Creation

This practical virtual live training course will teach the EU RMP creation skills from both industry and regulatory perspective, including the project management, medical writing, design, and maintenance of the document. It also includes preview of the GVP V Rev 3 and RMP Template Rev 3.

Early-Bird rate for DIA Industry Members Available!

DAYS

HOURS

MINUTES

SECONDS

Faculty

Emil Andrei  Cochino, MD, MHS

Emil Andrei Cochino, MD, MHS

Scientific Senior Specialist (Risk Management), European Medicines Agency, Netherlands

Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for Advanced Therapy Medicinal Products. Furthermore, he is overseeing the revision 3 update of GVP Module V – Risk Management Systems and is coordinating the Agency’s transparency efforts for RMPs.

Maria  Escudeiro dos Santos

Maria Escudeiro dos Santos

Risk Management Specialist, European Medicines Agency, Netherlands

Maria Santos has a Pharmaceutical Sciences master degree. She has joined the EMA in 2018 and is working in the Human Medicines Department as a Product Lead and Risk Management Specialist in the Vaccines and Therapies for Infectious Diseases office while collaborating with the revision 3 update of GVP Module V – Risk Management Systems.

Behija  Hudina

Behija Hudina

Pharmacovigilance Assessor, Agency for Medicinal Products and Medical Devices, Croatia

Behija Hudina has a University Master degree in Experimental Biology from the Faculty of Science at University of Zagreb. She joined the Croatian Agency for Medicinal Products and Medical Devices (HALMED), Department for Pharmacovigilance and Rational Pharmacotherapy in 2024 and currently works as a pharmacovigilance assessor. She also has previous 10 years of pharmacovigilance experience from working with various CROs.

Zeljana   Margan Koletic

Zeljana Margan Koletic

Director, Risk Management Strategy, Office of Risk Management, Abbvie, Croatia

Željana Margan Koletic joined the Croatian Agency for Medicinal Products and Medical Devices (HALMED) five years ago as an assessor in the pharmacovigilance department. She graduated in 2010 from the Faculty of Pharmacy and Biochemistry at University of Zagreb and she worked for several years as a community pharmacist. She participated in several pharmacovigilance projects and was a guest lecturer at University of Zagreb. Currently, she is working as Principal Coordinator for PSUR, DSUR and RMP assessment at HALMED and she is finalizing her thesis about biologicals and biosimilars at postgraduate specialist study “Clinical pharmacy” at University of Zagreb. Since 2016 she is a Croatian member of Pharmacovigilance Risk Assessment Committee.

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