Arifa Khan
U.S. FDA
Laurent Mallet
EDQM
Pieter Neels
IABS
Johannes Blümel
PEI
Jean-Pol Cassart
GSK Vaccines
Miia Jakava-Viljanen
FIMEMA
Ivana Knezevic
World Health Organization
Caine Logvinoff
Sanofi
Jelle Matthijnssens
KU Leuven
Egbert Mundt
Boehringer Ingelheim
Michael Wall
Health Canada

Confirmed Speakers

TBC

The e-Book will be available soon!

The Meeting Slides will be available soon!

Co-Chaired by:

IABS - https://www.iabs.org/

IABS Mission

The mission of the Alliance which is related to the scientific and medical advancement of Biologicals, includes :

  • To host conferences and workshops, facilitate communication, and develop consensus on key contemporary issues related to biologicals among those who discover, develop, produce and regulate biological products for human and animal health
  • To foster evidence-based Science as the standard for improving and ensuring the quality and the safety of biological products
  • To share scientific advancements and innovative regulatory solutions through our journal “Biologicals”.

FDA - https://www.fda.gov/

FDA Mission

  • The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.
  • FDA also has responsibility for regulating the manufacturing, marketing, and distribution of tobacco products to protect the public health and to reduce tobacco use by minors.
  • FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
  • FDA also plays a significant role in the Nation's counterterrorism capability. FDA fulfills this responsibility by ensuring the security of the food supply and by fostering development of medical products to respond to deliberate and naturally emerging public health threats.

EDQM - https://www.edqm.eu/

EDQM Mission

EDQM contributes to the basic human right of access to good quality medicines and healthcare, and promotes and protects human and animal health by:

  • establishing and providing official standards for the manufacture and quality control of medicines in all the signatory states of the Convention on the Elaboration of a European Pharmacopoeia and beyond;
  • granting Certificates of suitability which verify the compliance of pharmaceutical substances with European Pharmacopoeia standards and carrying out inspections of manufacturers of these substances;
  • co-ordinating a network of Official Medicines Control Laboratories (OMCL) to collaborate and pool expertise and to effectively use limited resources with the aim of achieving effective public quality control of medicines in Europe and beyond;
  • proposing ethical, safety and quality standards for blood transfusions (collection, preparation, storage, distribution and appropriate use of blood components) and organ, tissue and cell transplantation;
  • working with national, European and international organisations in efforts to combat counterfeiting/falsification of medical products and similar crimes;
  • providing policies and model approaches for the safe use of medicines, including guidelines on pharmaceutical care;
  • establishing standards for cosmetics and food contact materials and coordinating the public control of cosmetics.