Dr Peter Lassoff Pharm.D., FTOPRA, has over 30 years’ experience within global regulatory affairs and is the Senior VP, Regulatory Affairs, for Syneos Health. Peter has deep domain expertise in regulatory affairs and drug development, and has established and grown businesses in the regulatory outsourcing sector on a global basis. Peter is a Fellow of TOPRA, the professional society for regulatory affairs; is on the Board of Supervisors for the University of Southern California's regulatory affairs programme, and has won a lifetime achievement award for regulatory affairs, the Innovation in Regulatory Science Award at the USC School of Pharmacy.

J. Mark Wiggins is Director, Compendial Compliance and Advocacy at Merck, with >30 years experience in the pharmaceutical industry. His responsibilities include reviewing compendial changes from around the world to ensure ongoing compliance and establishing public quality standards for drugs. He has been an active participant in compendial harmonization efforts, and an invited speaker in international meetings with pharmacopoeias/regulators in the US, Europe, India, Japan, Korea, and China.