Since March 2016 the EU Guidelines to ascertain the appropriate GMPs for excipients of medicinal products for human use is legally binding. Although the EU Guideline itself provides a high level description how to perform the risk assessment, the implementation can be challenging.
On 17 December 2019, PDA and IPEC published a joint Technical Report to provide state of the art approaches and practical examples how to perform a risk assessment in line with the EU requirements.
The Technical Report is available on the PDA website for purchase for IPEC Europe Non Members: go.pda.org/tr54-6
DATE AND TIME
Thursday 12 March 2020 - 16:00-17:00 CET
Frithjof Holtz, Senior Expert Regulatory Intelligence Life Science, Regulatory Management, Merck KGaA / IPEC Europe Chair
Frithjof Holtz is a biologist working for nearly 30 years for Merck KGaA, Darmstadt, Germany. He has experience in operations, QA and has held over the last 15 years several positions in Regulatory Management (CMC) in Merck Life Science. Over the last years he has been working with a number of industry associations (e.g. Rx-360, APIC, EFCG, PDA, IPEC) and is a Senior Expert responsible for Regulatory Intelligence for Merck LS.
IPEC Members: € 60
IPEC Non Members: € 80
If you are unsure of your status, please contact the Secretariat at firstname.lastname@example.org
The registration fee for the webinar is not reimbursable. Substitutions are accepted. Webinar participants who are unable to attend should inform the IPEC Europe Secretariat (email@example.com) in writing and provide the name of the replacement, if applicable, no later than Monday 9 March 2020 eob.