HPRA Seminar on MAH Regulatory Compliance Inspection & Advertising Compliance Programmes

Acorn Regulatory staff were among the members of a capacity audience at the HPRA seminar on MAH regulatory compliance inspection and advertising compliance programmes that was held at the Hilton Dublin on November 27th 2017.

The event saw two speakers from the HPRA cover a number of topics.  Dr. Kevin O’Donnell, the Market Compliance Manager at the HPRA spoke about the 10 years of the HPRA’s regulatory compliance inspection programme and gave an overview of future plans for the programme.  During the course of his presentation he spoke about the scope of the inspections and what actions triggered them.  He also outlined the issues that have changed in the inspections over the last 10 years.  He concluded by discussing proposed changes to the plan and outlined what attendees need to do to achieve and maintain a high level of compliance.

Dr Kevin O'Donnell Dr Gemma Robinson HPRA Seminar Hilton Dublin Market Compliance November 27th 2017

Dr Kevin O’Donnell, HPRA with Dr Gemma Robinson, Acorn Regulatory at the HPRA Seminar in the Hilton Dublin on November 27th 2017

Rachel Gorman, Scientific Officer with the Advertising Compliance division gave an overview of the compliance programme at the HPRA.  She looked at some of the examples of good practice and outlined how companies could avoid simple pitfalls in the production of advertising materials.

There were a number of questions from the floor at the end of the event including a question from Acorn Regulatory founder and Managing Director Dr. Gemma Robinson regarding the inspection programme.

The event was held in association with the Irish Pharmaceutical Healthcare Association (IPHA).

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About the Author
Gemma Robinson, PhD
Managing Director
As Managing Director of Acorn Regulatory, Gemma Robinson is actively involved on client projects on a day to day basis and she leads a team of respected pharmaceutical, medical device, pharmacovigilance and clinical trial experts.  Gemma is also an active contributor to developing and promoting standards in the regulatory affairs profession and she has worked with a number of academic and not for profit organisations to encourage individuals to pursue a career in regulatory affairs and the broader STEM subjects. You can read more articles by Gemma by clicking the link below.
Other articles by Gemma Robinson PhD