Virtual Event

2025 年 09 月 16 日 1:00 下午 - 2025 年 09 月 18 日 5:30 下午

(Central Europe Standard Time)

4051 Basel, Switzerland

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!

03

DAYS

15

HOURS

01

MINUTES

32

SECONDS

讲师团队

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.

Klaudija  Marijanovic Barac, MD

Klaudija Marijanovic Barac, MD

Senior Director, Teva Periodic Reports and Risk Management Centre, Teva, Croatia

Klaudija is a physician with more than 20 years of experience in different pharmacovigilance fields. At present, she is Head of TPC – unit responsible for Company Core Safety Information, aggregate reports and risk management worldwide, supporting marketing authorizations and safety strategy for generics, biosimilar and innovative Teva products. Klaudija led in-house development of additional risk minimisation (ARM) implementation tracking tool and ARM digitalisation. Klaudija is Co-Chair of the Pharmacovigilance Working Group in Medicines for Europe.

Lara  Miletic, MPharm

Lara Miletic, MPharm

Princial coordinator for new safety issues, Agency for Medicinal Products and Medical Devices of Croatia, Croatia

Lara is a pharmacovigilance expert at the Croatian national competent authority (NCA) from 2019. She is involved in assessment of RMPs, PSURs, study protocols for post-authorisation safety studies and in safety signal detection. Lara is coordinating EU-co-founded project EU4Health Joint Action 12 “Safety assessment cooperation and facilitated conduct of clinical trials” (SAFE CT).

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