DIAアカウントをお持ちの場合、サインインしてください。

サインイン

ユーザーIDをお忘れですか? or パスワードをお忘れですか?

Virtual Event

2023年9月26日 (火) 午前 9:00 - 2023年9月28日 (木) 午後 1:00

(Central Europe Standard Time)

4051 Basel, Switzerland

Risk Management Plan (EU-RMP) Creation

FULLYY BOOKED! This practical virtual live training course will teach the EU-RMP creation skills, including the project management, medical writing, design, and maintenance of the document.

学部

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.

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.

Nuria  Semis-Costa, MSc

Nuria Semis-Costa, MSc

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

Núria Semis-Costa is a biochemist (Universitat Autònoma de Barcelona) with a MSc in Pharmacovigilance (Universitat de Barcelona). After working in the industry in the field of blood products, she joined the EMA as a Risk Management Specialist in 2015, where she works in the areas of rheumatology, immunology and advanced therapies. Núria is also involved in initiatives related to risk management of biosimilars and medicines in pregnancy, the maintenance of the RMP template and the update of GVP XVI.

最新情報や機会を逃さないで

DIAのメールを購読すれば、常に最新の業界情報やイベント情報を得ることができます。