How can we improve drug assessment?

Christelle RATIGNIER-CARBONNEIL

Vice-Chair at European Medicines Agency - EMA; Director General
French National Agency for Medicines and Health Products Safety - ANSM

France

Christelle Ratignier-Carbonneil holds a PhD in immuno-hematology and is a researcher by training. She has been appointed Director General of the ANSM in December 2020, after serving as Deputy Director General in charge of operations since December 2016.

She knows the Agency well, having held several positions related to the clinical and therapeutic evaluation of drugs from 2002 to 2010, particularly in the field of biologics, orphan drugs, pneumology-ORL drugs and self-medication...

In 2010, she joined the cabinet of the Minister of Labor, Employment and Health as advisor for health products and industries, where she had a central part in the creation of the Mediator victims' compensation fund, and then in the drafting of the law on the reinforcement of the sanitary safety of medicines and health products.

In 2012, her professional career continued at the CNAMTS where she was deputy director and head of the health products department, in charge of activities related to drugs, medical devices and biological procedures, as well as relations with pharmacists, medical device professionals and private medical biologists.

Antoine MIALHE

Senior Managing Director
FTI Consulting

Belgium

Antoine Mialhe is a Senior Managing Director in the Strategic Communications segment and is based in Brussels where he heads the Healthcare and Life Sciences practice.

Antoine Mialhe advises clients on the development and execution of evidence-based public affairs and policy communications strategies using data and health economics to develop compelling messages for a wide range of audiences in and around EU institutions as well as across Europe.
In his role, Antoine Mialhe advises large pharmaceutical companies, small and mid-size biotech companies, medical device companies and leading EU and international biopharmaceutical trade associations on a wide range of topics such as IP and incentives, digital health, AMR, biopreparedness, research and innovation. Beyond Brussels, he regularly provides counsel to clients active in neurology, oncology, or rare diseases and advises on the design and implementation of effective drug launch strategies across Europe. Throughout the COVID-19 pandemic, Antoine Mialhe contributed to securing two COVID-19 vaccine deals and one COVID-19 therapeutic deal with the European Commission worth over 5 billion EUR in total.
Before joining FTI Consulting, Antoine Mialhe worked for eight years as an EU official at the European Commission, DG Research and Innovation, Directorate Health. He contributed to the development and launch of the Innovative Health Initiative (“IHI,” formerly “IMI”), the world’s largest R&I Public Private Partnership in the health sector. He also piloted and launched the EIC Accelerator, the EU’s first program supporting innovative and fast-growing start-ups and small biotech companies. He also contributed to EU legislations impacting the sector such as the GDPR (health exemption), medical devices, in vitro diagnostics, clinical trials and HTA.