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
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
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).
Lorraine Nolan, PhD
Chief Executive
Health Products Regulatory Authority , Ireland
Dr 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 Dr Nolan was Director of Human Products Authorisation & Registration. Dr Nolan is a member of the Management Board of the European Medicines Agency (EMA) and as Chair of the Management Board of the EMA since March 2022.
Momir Radulovic
Executive Director
Slovenian Medicines and Medical Devices Agency (JAZMP), Slovenia
Momir Radulovic leads the Slovenian Medicines and Medical Devices Agency since December 2018. He is a member of EMA Management Board, a member of EC Pharmaceutical Committee, HMA Management Group, Chair of EURIPID Board of Participants and member of EU Network Training Centre Steering Group. His previous work experience includes Hospital and Community Pharmacy and Pharma industry, focused on oncology medicines, HIV and vaccines. By living and working in countries with diverse Health systems and cultural environments he has learned to adapt swiftly to changes and to seize the opportunities that those can offer. He has track record of strong results, enjoy prioritizing, simplifying complex ideas and acting on them with high levels of energy.
Sara Rafael-Almeida
Policy Officer
European Commission, Belgium