good manufacturing practice and marketing authorisation holders
In January of this year the EMA released a new draft reflection paper on Good Manufacturing Practice (GMP) and Marketing Authorisation Holders (MAHs) for consultation. This reflection paper is designed to provide clarity as to what the various GMP responsibilities are for MAHs and what they mean for MAHs at a practical level.
The draft document and the template for submission for comments are available at the following link: EMA – GMPs for MAHs Reflection Paper
The consultation period will finish on 17 July 2020.
Two of our Senior Consultants (Dairine Dempsey, former HPRA Assessor and Ann Ballesty, highly experienced QP) have analysed the text and will present on the implications of the document from a Regulatory and a GMP i.e. the responsibilities for MAHs and for manufacturers responsible for manufacture of medicinal products for which the MAH holds an EU licence.
Dairine and Ann will run a webinar to describe the requirements as outlined in the reflection paper and the potential implications based on the perspectives of both the MAH and the manufacturer.
This webinar will take place from 14:00 to 15:30 (Irish time) on Thursday 2 July. There is a €200 registration fee payable per person per webinar.
To register please complete the form below and follow the link to pay the registration fee.
In-house webinars for companies can also be arranged by contacting email@example.com
event date: tbc
individual price: €200 per person
location: This event will take place as webinar and will be hosted using the Google Meets platform. Following registration you will receive an invite to the event including login details
Terms & Conditions: Please Click here for Terms & Conditions