Former FDA and MHRA regulators will discuss how regulators are needing to employ desk-top inspection programs during the pandemic and also for the foreseeable future. They will also explain how Regulators are utilizing greater reliance on the work of other Regulators, and will also present on some key considerations to take to prepare your company for a desk-top inspection.
Robert (Bob) Iser
M.S. – Vice President, Parexel
Regulatory & Access
Bob Iser is a Vice President in Parexel’s Regulatory & Access Consulting group, providing technical leadership and expertise including development of global regulatory strategies on behalf of clients interfacing with Regulatory Agencies and through leading a team of global regulatory experts.
Prior to joining Parexel, Bob spent 14 years with the U.S. FDA (most recently as the Director of the Office of Process and Facilities in CDER) with experience in CMC review, pre-approval inspections, CGMPs, guidance & policy development, and training.
Before joining FDA, Bob worked for seven years in the biopharmaceutical industry.
M.Sc. – Vice President Technical, Parexel
Regulatory & Access
Mark Birse is a Vice President Technical in Parexel’s Regulatory & Access Consulting group. He is a strategically orientated regulatory compliance professional, with a career spanning the regulation of pharmaceuticals and medical devices. Mark has a passion for ensuring patient safety through delivering pragmatic, risk proportionate and innovative approaches to regulation, with a demonstrated success in building and leading high performing teams responsible for multimillion-pound income
Prior to joining Parexel, Mark previously worked at the MHRA where he held several leadership roles, including Deputy Director Inspection, Enforcement & Standards Division and Head of MHRA Inspectorate and Process Licensing Group, a team with over 75 GXP inspectors.
In these roles, Mark worked extensively with international regulators including FDA, EMA and TGA developing compliance and risk-based inspection methodologies with a focus on inspection collaboration and reliance. He was an Executive Bureau member of the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and also assessed the capability and performance of regulators and provided international training for both regulators and industry. Mark also held leadership roles in the MHRA Medical Device Division with responsibilities for Devices Safety and Surveillance & Software and Apps.
Mark’s background is in GMP having initially joined the MHRA in 2002 as a GMP Inspector where he performed inspections globally. Prior to joining MHRA he spent 10 years in Industry with responsibilities for technology transfer and supplier auditing. He is also eligible as a Qualified Person (QP).
Viswanadh works closely with biopharmaceutical companies for new business acquisition and positioning Parexel as a key strategic partner for Clinical, Commercial and Compliance segments. He brings on board close to two decades of global experience in corporate development, sales & marketing, new business development and portfolio management across products and services. He holds a Senior Management Program from the Indian Institute of Management, Kolkata and a Master’s in Veterinary Medicine with a specialization in Cardiovascular Physiology.