New members sought for the Advanced Therapy Medicinal Products Working Party (ATMP WP) - PCR

The British Pharmacopoeia Commission is currently looking to appoint new professional members within the coming weeks for a new task group focussing on providing non-mandatory guidance on the topic “dPCR and qPCR validation protocols and reports”. Members should have current expertise in:

Essential criteria

• Expertise in PCR assays, including experience in Lentivirus AND/OR Adeno-associated virus systems/products.
• Experience in designing and optimizing PCR assays OR conducting interference studies OR transferring from qPCR to dPCR.
• CMC experience submitting regulatory filings such as Biologics Licence Applications or Marketing Authorisations.
• Utilising appropriate data analysis methods to ensure accurate and reliable interpretation of the assay results.

Desired criteria

• Be available for a MS Teams Meeting on 31 May from 14:00-15:30.

If you’re interested in becoming a member, please send your CV to BiolStandards@mhra.gov.uk

The closing date for expression of interest is midday on 2 May 2023.