Implementing MHRA’s New Guidance for Own Brand Labelling or ”Virtual Manufacturers”
Tuesday, July 18, 2017 – 10:00AM EDT to 11:00AM EDT (3:00PM to 4:00PM British Summer Time)
This course is forecasted for a 45 minute presentation followed by 10 to 15 minutes of Q&A.
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) released new guidance which redefines Own Brand Labelling (OBL) as “Virtual Manufacturers” and contains more stringent requirements for demonstrating compliance. Virtual manufacturers with marketed products in the UK are now required to provide full technical documentation and audit quality management systems to corroborate alignment with the mandated regulations. The guidance reflects the EU’s initiative to increase product scrutiny and is expected to have a significant effect on the collaborations between “Original Equipment Manufacturers” (OEM) and OBLs. With the guidance coming into force on September 1, 2017, OEMs and virtual manufacturers have a significant undertaking ahead.
- Defining and fulfilling requirements for full technical documentation
- Approaches for handling proprietary data and justification for redaction
- Improving partnership agreements to ensure universal compliance
Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:
- Regulatory Affairs
- Quality Assurance
- Supplier QA
Head of the Notified Body for Medical Devices
Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been a part of the team for many commercially available medicinal and medical device products.
Theresa has over 9 years Notified Body experience as a technical expert at BSI and technical manager at LRQA. Her area of technical expertise is in device-drug combinations and borderline classifications, and she has completed many successful consultations in this area with many European Competent Authorities and EMA. She has recently been promoted to the Head of the Notified Body position for Medical Devices at the UK Notified Body – LRQA.