Back to Agenda
What does Good Look Like? Shaping the Environment to Manage Antimicrobial Resistance and Promote Sustainable Development of Anti-infectives and Vaccines
Session Chair(s)
Sabine Haubenreisser, PhD, MSc
Principal Scientific Administrator, Stakeholders and Communication Division
European Medicines Agency, Netherlands
Inka Heikkinen, MBA, MS, MSc
Regulatory Policy Lead
Lundbeck, Denmark
Antimicrobial resistance is a major public health concern with increasing urgency; no stakeholder or policymaker alone can solve it. To take stock of the various initiatives and discuss collaborative efforts, the session gathers leaders from different stakeholder groups to identify the synergies between the EMA RSS, European Regulators’ Network Strategy, Pharmaceutical Strategy and ICMRA to create a sustainable environment for antimicrobials, anti-infectives and vaccines. • EMA RSS: support innovative approaches for development and approval – learnings from Covid and other vaccines development, accelerated development • Network strategy: identify regulatory blind spots & define pull incentives: what is needed to enable market sustainability?, HTA collaboration • Pharma strategy: fiscal and financial systems and novel business models: de-linking sales from volume, push incentives, EU BARDA • ICMRA: finding synergies across the borders: connecting the global ecosystem to generate sustainable results
Learning Objective : The present pandemic has forced a rethink about some aspects of the governance of pharmaceuticals and the resilience of the current regulatory framework under crisis conditions. The world has experienced what is regularly described as an “unprecedented” crisis, caused by a virus which has challenged our expectations and healthcare systems, including the regulatory systems.
Speaker(s)
Panelist
Alan Morrison, PhD
MSD, United Kingdom
Vice President Regulatory Affairs Intl
Panelist
Emer Cooke, MBA, MSc
European Medicines Agency, Netherlands
Chair, ICMRA; Executive Director
Panelist
Karl Broich, DrMed
Federal Institute for Drugs and Medical Devices (BfArM), Germany
President
Panelist
John F. Ryan
European Commission , Luxembourg
Director for Public Health - European Commission, DG Health and Food Safety
Panelist
Jesús Rodríguez Baño
Hospital Universitario Virgen Macarena, Unidad Clínica de Enfermedades Infeccios, Spain
Head of the Infectious Diseases
Panelist
Tiago Villanueva
UEMO, Portugal
Vice-President
Have an account?