EU Regulatory Affairs introductory training course

Chairperson CMDh EU representative at the MEB; Kora Doorduyn works at the Medicines Evaluation Board (MEB) in The Netherlands. She held several positions within the MEB, both regulatory and management. Her current position (since 2009) is CMDh member (EU-representative)/Senior Policy adviser. Since May 2009 she is acting as Member and official representative in the CMDh (Co-ordination Group Mutual Recognition and Decentralised Procedures - Human) on behalf of the MEB. In December 2018 she was elected as Vice-Chairperson of CMDh. She is member of several working parties of CMDh with issues related to Pharmacovigilance legislation (like RMPs/PSUSA's) and variations as an area for special attention. She is acting as CMDh rapporteur for a (HaRP) project to harmonise RMPs for the same active substance in the EU. She is coordinator/Rapporteur EU Training Curriculum for Regulatory experts (for CMDh). She is the NL member of the Notice to Applicants Working Group in Brussels. She graduated MSc Pharmacy (in 1983) and as a pharmacist (in 1985).

Lawyer; His prime interests are the interdisciplinary challenges of medicinal product law. His focal advisory areas are as follows: - European and German medicinal product law - Marketing authorisation law & regulatory affairs - Pharmacovigilance - Wholesale trade with medicinal products, distribution of medicinal products - Manufacture of medicinal products
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Senior Regulatory Project Leader

Regulatory Affairs, Compliance and Pharmacovigilance Consultant, ITALY

Ida Caramazza has a Degree in Pharmaceutical Technology and Chemistry and a Diploma as Specialist in Toxicology . She has been working in the Pharmaceutical field since the '80s. Her experience started with preclinical research activity in Pharmaceutical Companies and then continued in the regulatory affairs sector, working for Regulatory Consultancy Firms and for international Pharmaceutical Companies, being involved in Regulatory Affairs activities mainly on medicinal products, but also on other healthcare products, such as medical devices, food supplements and cosmetics. Currently she works as Senior Regulatory Affairs Consultant on regulatory strategy projects, regulatory activities, training in regulatory field. She is also involved in teaching activities at University masters in Regulatory Sciences.

Regulatory Consultant
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Director, Principal Consultant Regulatory Operations Nach seinem Studium war Herr Loebel mehrere Jahre Mitarbeiter der Universität Heidelberg bevor er im Jahr 2000 zu einem Biotechnologie-Startup-Unternehmen wechselte. 2005 begann seine Laufbahn bei der PharmaLex GmbH, Mannheim, wo er zunächst die Position des Head of Regulatory Operations und seit 2014 die Position des Associate Director Regulatory Operations innehat. Sein Aufgabengebiet umfasst u.a. die Betreuung elektronischer Einreichungen, Projektplanung und die strategische Beratung von Pharma-Unternehmen in diesem Bereich.
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