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Online

Risk Management of Medicinal Products: REMS and RMP - Need for Harmonization Within the ICH Region?

Speakers

Irene  Bognar-Steinberg, PhD

Irene Bognar-Steinberg, PhD

Head of Medical Affairs, Helm AG, BU Pharma, Germany

Reingart  Bordel, DrSc, MS

Reingart Bordel, DrSc, MS

Senior Manager Pharmacovigilance and Regulatory Affairs, Dr. Ebeling & Assoc. GmbH, Germany

Dr. Reingart Bordel is senior manager at a CSO. Her work experience includes signal management, continuous benefit-risk analyses and compilation of PSURs/PBRERs, risk management plans and (e)CTDs. General topics are pharmacovigilance and international requirements for the authorization of drugs.

Leonardo  Ebeling, DrMed, PhD

Leonardo Ebeling, DrMed, PhD

Managing Director, Dr. Ebeling & Assoc. GmbH, Germany

Dr. Leonardo Ebeling, general manager and co-founder of Dr. Ebeling & Assoc., located in Hamburg, Germany. He studied medicine at the universities of Marburg and Hamburg. After completing his studies in 1984, he worked for big and medium-sized pharmaceutical companies in leading positions. In 1998, Dr. Ebeling launched his CSO company providing drug safety services in medical science, pharmacovigilance, risk management and regulatory affairs based on his extensive industry experience.

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