Please see the invitation by TLSC-member LINK Medical below:
Join us November 28 in Oslo where we have gathered former GCP Inspector Gunnar Danielsson, and well-known industry expert Randi Riise under one roof to share their knowledge and experiences. In this seminar, you will learn how to prepare for a GCP inspection, what happens during a GCP inspection and how should you follow-up the GCP inspection. This is a rare and limited seat event!
12:30 Registration/small snack lunch
13:00 Lecture start part I with Gunnar & Randi
14:30 Break /coffee (15 min break)
14:45 Part II with Gunnar & Randi
16:30 Questions / Answers
17:00 Mingle Start
In this lecture you will learn about the following subjects:
- How do you prepare for the GCP inspection?
- What happens during the GCP inspection?
- How should you follow-up the GCP inspection?
About the speakers
Gunnar Danielsson, former GCP inspector has traveled around the world performing GCP inspections for the Swedish Medical Product Agency for over 10 years. He has 40 years’ experience in Clinical Research and has a wealth of experience from the Pharmaceutical industry in terms of quality management, electronic systems, data management, and clinical design and conduct. Gunnar today is a key advisory resource and helps to design studies in the most effective way, meeting regulatory requirements.
Randi Riise has been working 40 years in the pharmaceutical area with experience from Big Pharma, small biotech and Health Authorities. She was the first GCP inspector at the Norwegian Medicines Authority and established procedures for GCP inspections in Norway.
In the last 15 years, she has been working at LINK Medical, holding a variety of positions within Regulatory Affairs, Clinical Operations, and QA.
Randi graduated with a Master’s degree in chemistry from the Norwegian University of Science and Technology, 1977. She is also a certified Quality Auditor.
This is a free event that includes a small lunch.
If you have any questions regarding registration or anything else, please don’t hesitate to contact me.
Nina Cecilie Herud
Marketing and Brand Manager
+47 41 25 30 36