Planning with the end in mind
When: Postponed
Join our team for a free event in Copenhagen!
Two of our most senior experts in clinical development and Good Clinical Practice (GCP) will share their knowledge and discuss quality from two different perspectives:
- The quality that comes from preparing for a GCP inspection, based on the requirements of the regulatory authorities
- The quality that comes from defining a product based on the markets’ requirements, using a Target Product Profile (TPP)
Using a TPP as a map lets you understand what you need to achieve for your product to be successful.
Product development is not just about doing things right, it is about doing the right things.
Agenda:
13:30 Light lunch and registration mingle
14:00 The importance of thinking with the end in mind – Kim Simonsen
14:40 Preparing for an Inspection – Gunnar Danielsson
15:20 Q&A
15:30 Mingle with refreshments
16:30 End
Speaker bios:
Gunnar Danielsson,
Sr. Regulatory Advisor and former GCP inspector
Gunnar.Danielsson[@]linkmedical.eu
Gunnar Danielsson is a former GCP inspector who traveled the world for over 10 years performing GCP inspections for the Swedish Medical Product Agency. He has 40 years of experience in clinical research and a wealth of expertise in the areas of quality management, electronic systems, data management, and clinical study design and conduct. Today Gunnar is a key advisory resource and supports teams with effective study design and regulatory compliance.
Kim Simonsen,
Medical Expert consultant
Kim.Simonsen[@]linkmedical.eu
Dr. Simonsen has long experience in drug development, having led the development of the first marketed immunotherapy tablet for grass pollen allergy, among other important achievements. He has held senior management positions at Galapagos, Anergis, and ALK Abello A/S, as well as clinical development roles at Novartis and Novo Nordisk A/S.
