Technical Advisory Boards
The four PDA Technical Advisory Boards (ABs) are composed of a diverse group of experts drawn from industry, regulatory agencies, and academia who work to provide scientific and technical expertise to the PDA Board of Directors and provide support and guidance for PDA’s scientific, regulatory, and technical initiatives. PDA ABs also support the ongoing activities of PDA Interest Groups in which PDA members review, discuss, and advance industry understanding of technical and quality topics. Each AB also contributes to PDA’s educational mission by assisting the Training and Research Institute (TRI) in curriculum development.
ATMP AB (Advanced Therapy Medicinal Products Advisory Board)
The ATMP AB provides guidance and sets strategic direction for PDA on technical topics associated with cell, gene, tissue, and other novel therapeutic modalities. These may include:
- Raw and ancillary materials
- Drug product and drug product manufacturing science
- Quality systems
- Product and process comparability
- Analytical methods
- Supply chain
BioAB (Biopharmaceutical Advisory Board)
The BioAB is focused on technical topics associated with biopharmaceutical and biotechnology-related manufacturing and quality. These may include:
- Raw and ancillary materials
- Upstream and downstream processing science for biopharmaceutical manufacturing
- Product class-specific manufacturing and quality testing aspects for vaccines, protein therapeutics, and other biologics
- Emerging technology, including analytical methodology and data application
RAQAB (Regulatory Affairs and Quality Advisory Board)
The RAQAB provides guidance and sets strategic direction on regulatory and quality topics spanning the lifecycle of healthcare products. These may include:
- Advancing harmonization, convergence and alignment in the regulatory space through regulatory engagement and advocacy
- Driving and advancing guidance for industry
- Scanning and analyzing the regulatory horizon
- Addressing such quality topics as quality risk management, data integrity, and quality metrics and quality culture
SAB (Science Advisory Board)
The SAB is the longest standing Advisory Board and addresses technical topics associated with overall pharmaceutical manufacturing and quality. These may include:
- Aseptic processing, sterility assurance, and microbial testing
- Manufacturing science
- Packaging science including visual inspection
- Product quality analysis and testing
- Analytical method development
- Application of data science