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Ireland Regional Forum - Chain Reactions and Interactions

Chain Reactions and Interactions - still protecting drug efficacy, quality, safety

 

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: 

Acorn Regulatory logo

Speakers to include

Alison Wilson
Senior Pharmacokinetist, Almac Sciences (Ireland) Ltd

Anne Hayes
Inspection Manager, HPRA and Deputy Chairperson PIC/S

Gemma Robinson
Managing Director, Acorn Regulatory Consultancy Services Ltd

Patricia Pengelly
RDQA Area Head EEMEA, Abbvie

Mary Burke
Consultant and Non-Ex Director at BioClin/Almac

Pat Lennon
Compliance Manager, Roche Ireland

Programme

 Please note timings are subject to alteration

9.00 Registration
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
15.50 Closing Comments

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