Plunkett Consulting is pleased to welcome the addition of Chris Rolls to its regulatory consulting team.
Chris Rolls recently finished up with the Therapeutic Goods Administration (the Australian National Regulatory Authority) in August 2014 after 26 years of vaccine regulation, and is now working with Plunkett Consulting to continue to provide regulatory and quality assurance advice to the vaccine and biological products industry.
During his time with TGA, Chris provided and managed regulatory services, including Lot Release and direct QC testing for vaccines for supply in Australia, review of marketing application dossiers, for both vaccine quality. Also, Chris has been instrumental in enhancing Bacterial Endotoxin safety in pharmaceuticals more broadly, and in specialist inspection of manufacturers in Australia and overseas. Chris is held in high regard in the industry for his accumulated expertise and open advice in both vaccine quality issues and regulatory systems more generally.
Chris also had the opportunity to work closely with the World Health Organisation, both through TGA and “on secondment” to Geneva, and was involved in the development of the vaccine regulatory strengthening program from it’s inception and in providing specialist advice to the vaccine pre-qualification program. He has assessed and advised vaccine regulators & manufacturers around the world, and conducted and advised in training courses on a global basis, in all aspects of vaccine quality and regulation. Many of those who have trained under Chris are now experts with WHO and in vaccine regulators & manufacturers around the world.
Chris is a great addition to the team and will effectively support our clients by providing a unique perspective on pharmaceutical regulation.