*** THIS EVENT IS NOW FULLY BOOKED ***
Overview:
Join us on April 30th for a transformative masterclass focused on the essential aspects of quality and regulatory compliance in the pharmaceutical industry. This event is tailored for Quality and Regulatory professionals who wish to deepen their understanding of this complex area ensuring the safety, efficacy, and quality of pharmaceutical products. We will have a range of expert speakers sharing their expertise throughout the day including Kevin O’Donnell, Market Compliance Manager and Senior GMP Inspector at the HPRA.
Why Attend?
In an increasingly complex regulatory landscape, the importance of quality compliance cannot be overstated. This masterclass offers a unique opportunity to engage with industry experts, participate in meaningful discussions, and network with peers. With a limited capacity of seats, participants will benefit from a collaborative environment conducive to in-depth exploration of key topics.
Who should attend?
This masterclass is ideal for professionals involved in Quality and Regulatory compliance, including:
- Quality Assurance Managers
- Regulatory Affairs Specialists
- Compliance Officers
- Auditors
- Anyone seeking a deeper understanding of quality and regulatory frameworks in the pharmaceutical sector.
Costs include all materials, lunch and a light breakfast.
Costs to non-members includes full membership of the PMI for the remainder of this year. This provides access to the Resources library in the member section of our website and access to PMI events throughout the year at the member rate.
Further speakers will be confirmed shortly.
Places are strictly limited. Don’t miss this opportunity to enhance your expertise and ensure your organisation stays at the forefront of quality and regulatory compliance in the pharmaceutical industry!
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Speakers:
Kevin O’Donnell, Market Compliance Manager and a Senior GMP Inspector – HPRA
Kevin is Market Compliance Manager and a Senior GMP Inspector at the Health Products Regulatory Authority (HPRA) in Ireland. He has been with the HPRA since 2001. Kevin obtained his PhD in Quality Risk Management (QRM) from the Dublin Institute of Technology in 2008.
He is currently Chair of the PIC/S Expert Circle on QRM, and he is also Rapporteur for the revision of ICH Q9.
Topic: The effectiveness of the Pharmaceutical Quality System – managing risk and knowledge
Topic: Preparing for a HPRA Regulatory Compliance Inspection
Edward Mc Gettrick, Director – Global & EU Regulatory Lead – Pfizer
Edward is currently working as ‘Director – Global & EU Regulatory Lead’ in the Infectious Disease, Internal Medicine & Global Brands Unit in Pfizer. He is responsible for designing and implementing regulatory strategies for early- and late-stage clinical assets across cardiology, metabolic disorders and non-malignant haematology (haemophilia and sickle cell disease).
Previously, he was a Senior Manager – Regulatory Strategy in the Rare Disease Research Unit in Pfizer. He has also served as Senior Medical Advisor in Pfizer Healthcare Ireland, mainly in the gastroenterology / hepatology therapeutic areas. Prior to his roles at Pfizer, he previously worked in pharmaceutical regulation in both MSD Human Health Ireland and the Health Products Regulatory Authority (HPRA, formerly known as the Irish Medicines Board), and prior to that, he held clinical pharmacy roles in both hospital and retail.
From an educational perspective, Edward is a qualified pharmacist (~18 years), graduating with a Bachelor’s Degree in Pharmacy from Trinity College Dublin. He has also completed a Master’s in Management from Smurfit Business School, a Diploma in Health Economics from the Institute of Public Administration and a Professional Certificate in Pharmaceutical Medicine from Kings College London.
Lynne Dalton, Associate Director Quality Operations – Bristol Meyers Squibb
Lynne is an accomplished Associate Director of Quality Operations within the Bristol Myers Squibb External Manufacturing Organization. In addition to her professional achievements, Lynne is a dedicated advocate for gender Diversity and Inclusion, serving as the lead for the BMS Network of Women in Ireland. With a robust background in Quality Systems, She brings extensive experience in Quality Risk Management, Inspection Readiness and Management Review from her tenure at BMS. Additionally, Lynne has a strong background in Quality Control, Supplier Quality Management, New Product Introduction (NPI), and Human Error Reduction from her time at Pfizer Grange Castle. She holds a BSc in Analytical Science from Dublin City University (DCU) and an MSc in Quality Assurance and Regulation from Technological University Dublin (TUD).
Joe Brady, QA Consultant – The Compliance Group
Joe Brady is a consultant with The Compliance Group and is a highly experienced pharmaceutical manufacturing professional with 28+ years of process, technical, validation, regulatory, and quality assurance experience. Joe has a BSc and PhD in biotechnology from Dublin City University. Joe also holds a formal lectureship position (21+ years) with Technological University Dublin, teaching MSc programs in pharmaceutical quality assurance and pharmaceutical validation technology.
*** THIS EVENT IS NOW FULLY BOOKED ***
Please note that by registering for this event you agree to share your name and company details with the organisers and the event sponsor.
