It seems more accurate now than ever that ‘Uncertainty is the only certainty there is’ and the RQA is here to help! We cannot guarantee a complete mindset change to one where such insecurities are embraced as a positive but we are here to provide some support.
We will cover a broad range of topics on the latest trends and concerns across all GxPs including Clinical and Pre-Clinical testing, Falsified Medicines, Pharmacovigilance, Data Integrity and GDPR.
A fantastic line up of current (and ex) Inspectors from the HPRA, MHRA and a range of industry experts are waiting to share their knowledge and field your questions.
Note: Potential attendees should be aware that it is possible likely certain that Brexit will be discussed in detail!
Kindly sponsored by:
Senior Pharmacokinetist, Almac Sciences (Ireland) Ltd
Inspection Manager, HPRA and Deputy Chairperson PIC/S
Managing Director, Acorn Regulatory Consultancy Services Ltd
RDQA Area Head EEMEA, Abbvie
Consultant and Non-Ex Director at BioClin/Almac
Compliance Manager, Roche Ireland
Please note timings are subject to alteration
|9.30||Welcome and Opening Remarks|
|9.40||The role of pharmacokinetics to aid pharmaceutical development (data integrity, alcohol effects and IVIVC)|
|10.20||EU Safety Features for Pack Integrity and Authenticity|
|11.00||Refreshment break and Networking|
|11.30||Brexit and Regulatory Updates|
|12.10||Latest Trends in Pharmacovigilance|
|12.50||Lunch and Networking|
|14.00||FDA and EMA approaches to Bioanalytical Method Validation|
|14.40||Refreshment break and Networking|
|15.10||A year in the life of GDPR|