Inka has been involved very closely in HTA Regulation implementation at EFPIA since the very beginning. She leads EFPIA workstream around regulatory-HTA interaction and Joint Scientific Consultation, with extensive work on defining industry positions and thinking around the future processes and system on Marketing Authorisation review process and Joint Clinical Assessment. As her day job, she leads R&D and regulatory policy strategy and operational excellence at Lundbeck, working with senior leaders defining and advocating for policies that optimizes the environment for future health technologies. Inka holds master degrees on health economics and in policy, an Executive MBA degree with specialisation in finance.

Alastair has worked in various roles in pharmaceutical product development, before moving into regulatory publishing at a major clinical research organisation. He then headed the International Regulatory Operations function at SmithKline Beecham and GSK, and as Director of Publishing, he led the UK based publishing team, working on the implementation of eCTD in the company. Alastair is now Director, Submission Standards at GSK, responsible for ensuring that GSK’s strategy with respect to electronic submissions and IDMP is aligned with external requirements. He is a member of the EFPIA IDMP Sub Group and active on several European projects, such as eAF and DADI. Alastair has a BSc (Hons) in Applied Chemistry from Aston University in B'ham.

Hans van Bruggen has been involved in the transition form paper to digitalized paper to data exchange to data sharing. Key areas of expertise: lean regulatory documents, data capture right-first-time, and reuse rather then recreate or copy. Hans has an MSc in Pharmaceutical Medicine from the University of Surrey and has worked within, or for, the pharmaceutical industry for more than 30 years in Global or European Headquarters. Using that scientific background he brings together people, processes and tools, leading to lean interdisciplinary and international processes.

Susanne Ausborn has more than 20 years of experience in technical regulatory affairs and regulatory policy, being currently Global Head International Regulatory Policy in Roche. M.Sci. in Analytical Chemistry and PhD in Biophysical Chemistry, Susanne is a strong advocate for global convergence of regulatory requirements and has been engaged in many international conferences, workshops and meetings with regulators from various emerging markets around the world over the last decade. Currently, she is the Vice Chair of the EFPIA IREG, member of EFPIA Middle East network and several IFPMA expert groups.

Karl’s experience in positions of responsibility within regulatory operations spans a period of 6 years with particular focus on e-documentation and the associated systems that support the ability to manage and be compliant with the connected regulations. Highlights include his involvement in a global capacity providing counselling and support on optimisation of eCTD compilation and his current position which has seen him involved in working groups on current ISO issues faced by Eudravigilance and Regulatory professionals.

Tomas Salmonson, M.Sc., PhD, brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency in Uppsala, Sweden. He has been a member of the Committee for Medicinal Products for Human Use (CHMP) for more than 12 years. In 2012, Dr Salmonson was elected chair of the CHMP; he was Vice chair of the CHMP from 2007 till 2012. Tomas has been DIA Advisory Council of Europe Member during 1996-2002 and a speaker in over 20 DIA Events.

Petra Doerr has been Director of the EDQM since September 2021. She is a pharmacist/PhD and has spent the first ten years of her career in the medical products industry, working in international regulatory affairs. She joined Swissmedic in 2004 as Head of International Affairs and has been Head of Management Services & Networking and Member of the Management Board since 2007. From 2014 until 2019, she held the position of Head of Communication & Networking and Deputy Executive Director. Since 2019, Petra has been director and owner of Petra Doerr Consulting Ltd., providing consultancy services to not-for profit organizations. She has been Head of Unit Regulation and Safety at the World Health Organization from November 2020 to August 2021.

Marloes has a MSc in Drug Innovation with focus on regulatory affairs. She started at Roche as an intern in 2010 and has since progressed to a Regulatory Intelligence Manager and currently works as Regional Regulatory Policy Lead. She focuses on acquiring and maintaining an overview of the global biotherapeutics environment (guidelines, policies and products) in order to develop and implement global regulatory strategies to support the Roche position of biologics and seek support and alignment with Innovator Pharma Associations. Marloes has participated DIA Young Professional Fellowship and been a speaker at Euromeeting student sessions and actively supported development of other DIA conferences.

Dr. Razhdzestvenski has over 16 years' experience in the Regulatory Affairs system. He has medical background and also graduated as a clinical pharmacologist. Starting as an assessor in the Belarus Center of Expertise and Testing in Health Service, he worked as a Head of Clinical Pharmacological Laboratory, Ministry of Health, Republic of Belarus till 2014. Since 2014 Dr. Razhdzestvenski is working at the Eurasian Economic Commission in the Division for Coordination of Common Market for Medicinal Products and Medical Devices Formation, which is coordinating activities on Common medicines market regulations development in Eurasian Economic Union.