Engaging in the EU Regulatory Network: Member State Journeys

The session will describe the journey regulatory agencies such as HPRA and SAM have been on to raise their profiles and highlight the expertise they contribute to the EU regulatory network, including topics such as horizon scanning, capacity building and collaboration.

The session will describe the journey regulatory agencies such as HPRA and SAM have been on to raise their profiles and highlight the expertise they contribute to the EU regulatory network, including topics such as horizon scanning, capacity building and collaboration.

Session Chair(s)

Kristiina  James

Kristiina James

Regulatory Product Lead, MEAR

Abbvie Ltd, United Kingdom

Kristiina is a Regulatory Policy and Intelligence Senior Manager at AbbVie Ltd with a focus Central and Eastern Europe. Prior to joining AbbVie in 2014 Kristiina held regulatory positions at Pfizer in the UK and Alltech in the UK and Ireland. Kristiina holds a BSc(Hons) degree in Chemistry with Forensic Studies from the University of Glasgow.

Speaker(s)

Katrin  Kiisk, MD, MPH

Katrin Kiisk, MD, MPH

Deputy Director General

State Agency of Medicines, Estonia

Ms. Kiisk has been working at the Estonian State Agency of Medicines since 2002. During 17 years with the Agency she has held several positions, including Head of the Bureau of the Clinical trials and Head of the Marketing Authorisation Department. Since 2012 she is Deputy Director General of the Estonian State Agency of Medicine. She is the alternative member of The Pharmacovigilance Risk Assessment Committee (PRAC) since the beginning of this committee in 2012. She is also Estonian representative on the Expert Group on Safe and Timely Access to Medicines for Patients (STAMP).

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Lorraine  Nolan, PhD

Lorraine Nolan, PhD

Chief Executive

Health Products Regulatory Authority (HPRA), Ireland

Ms Nolan joined the HPRA in 2001 and since that time has held a number of different roles at senior level within the organisation across a range of areas including inspection and authorisation of human medicines, medical devices, cosmetics and controlled substances. Prior to assuming the role of Chief Executive she was Director of Human Products Authorisation & Registration. Ms Nolan is a member of the Management Board of the European Medicines Agency (EMA), and is also it’s vice chair. Ms Nolan is also a member of the EU HMA Management Group.

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Momir  Radulovic

Momir Radulovic

Executive Director

Slovenian Medicines Agency (JAZMP), Slovenia

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Sara  Rafael-Almeida

Sara Rafael-Almeida

Policy Officer

European Commission, Belgium

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