Justina Ann Molzon, former Associate Director for International Programs, Center for Drug Evaluation and Research, US Food and Drug Administration, 1999-2014. Molzon is an expert in regulatory harmonization and capacity building of international drug regulatory authorities. Career US Public Health Service officer serving for 30 years with a retired rank of Captain. Juris Doctor, Illinois Institute of Technology Chicago-Kent College of Law, Chicago, Illinois, Master of Science in Pharmacy, University of Rhode Island, Kingston — Pharmaceutics, Bachelor of Science, University of Rhode Island, Kingston, she graduated with honors and distinction and was selected for Rho Chi.

Maria has 30+ years of Pharmaceutical industry experience mainly in Quality.With Pfizer since 1991; she managed analytical laboratories, including the Quality Control Laboratories, and was the Brooklyn Site Quality Operations Director prior to assuming a Center position. Current, she is responsible for developing strategies to address emerging regulations and guidance documents in the areas of GMPs and pre- and post-approval filings (Chemistry Manufacturing and Control, CMC), and assisting in development of company positions and responses to proposed regulations and guidances. Her focus is mainly US and Latin America. She holds a degree in Pharmacy from the University of Buenos Aires and a PhD in Organic Chemistry from New York University.

Ana has over 19 years of pharmaceutical industry experience starting in Analytical Development (2-year) and then Regulatory Affairs area by working for Medley (Brazil), Novartis (Brazil and Switzerland), Parexel (Brazil) and in the last 8+ years for Roche leading the CMC Regulatory Policy activities for Latin America (Brazil and Uruguay). Ana is currently working since January 2019 as Associate Director at Merck Serono in CMC Regulatory Intelligence team in Switzerland. Ana holds a Biochemistry and Pharmacy Bachelor’s Degree at Sao Paulo Public University (USP) and a Master Degree in Pharmacology with focus on bioequivalence studies at Campinas Public University (UNICAMP).

Mike Ward is Coordinator of the Regulatory System Strengthening Team, Department of Essential Medicines and Health Technologies, Health Systems and Innovation Cluster, WHO Headquarters; he joined WHO as the Coordinator, Prequalification Team, in this same Department. He previously worked within Health Canada as GMP specialist, drug evaluator and manager, international policy analyst, and Manager of the International Programs Division of the Therapeutic Products Directorate. Mr Ward served on many international harmonization steering committees and helped to launch the APEC Regulatory Harmonization Steering Committee, the International Generic Drug Regulators Pilot, and the International Medical Device Regulators Forum.

Daniela Decina is Senior Director of Regulatory CMC at Mapi, leading a team focused on CMC strategy and dossier execution for all product phases for pharmaceuticals and biologics in the United States, Canada, and Europe. She has 28 years of experience in the pharmaceutical industry in Regulatory CMC, supporting small molecules and biologics, including biosimilars and vaccines. Prior to joining Mapi, Ms. Decina served two years in global public health within the World Health Organization’s Regulatory Systems Strengthening Team, supporting regulatory guidelines development and the Polio Eradication and Endgame Strategic Plan. She has a BS and MS degree in Microbiology from the University of Guelph.

Prisha Patel is the Manager for the Global Development programme at the Centre for Innovation in Regulatory Science (CIRS), London, focusing on emerging markets. Her responsibilities include managing the emerging markets industry benchmarking and agency benchmarking projects and working with regulatory agencies on special projects. Most recently Ms Patel served as a co-author of several publications including R&D Briefing 58: The changing regulatory environment in Latin America and along with Hashan, Aljuffali and Walker, The Saudi Arabia Food and Drug Authority: An Evaluation of the Registration Process and Good Review Practices in Saudi Arabia, published in Pharmaceutical Medicine in 2016.

Balbiana Oliveira has degree in Pharmacy and Biochemistry from Federal University of Minas Gerais, specialization in Sanitary Surveillance from Oswaldo Cruz Foundation - Fiocruz and master degree in Health Science from University of Brasilia. She has been working in Brazillian Health Regulatory Agency (Anvisa) since 2005 and was a member of the reviewer team of New Drugs Division from 2005 to 2013, working with the evaluation of clinical protocols and applications for development and registrations of innovative medicines. She was coordinator of the Coordination of New Drugs for 2 years. Since 2013, she is working as Advisor of Director at Anvisa with good regulatory practices, regulatory harmonization and drug regulatory issues.

Mrs. Brenda Valente is a pharmacist and holds the position of Specialist in Regulation and Health Surveillance in the sanitary authority in Brazil, the Brazilian National Health Surveillance Agency (ANVISA). She has been working since 2005 as a reviewer at the department responsible for the assessment of marketing authorization and post registration changes of biological products. She has participated in the elaboration and revision of regulation and guidelines regarding biological products in Brazil.

Cristina is currently Director at AbbVie where she coordinates regulatory policy and intelligence activities for the Emerging Markets. Cristina worked for Boehringer Ingelheim for 13 years in different roles including Quality, Validation and Regulatory Affairs. Cristina attended Universidad Nacional Autonoma de Mexico where she got her Pharmacy Degree and a Masters in Industrial Administration.

Mark S. Paxton currently serves as Associate Vice-President, Regulatory Affairs for Pharmaceutical Research and Manufacturers of America (“PhRMA”). In that capacity, Mr. Paxton is primarily responsible for advocacy related to Supply Chain Security.

Ms. Pineda joined the U.S. FDA office in Mexico on March, 2013. She has a BSc on Chemistry, Pharmacology and Biology from the UNAM and a MSc on Toxicology from the CINVESTAV/IPN. She started her professional career in the pharmaceutical industry in the production area. In 2001 she joined the Mexican Government as Head of the Toxicology Department at the Ministry of Health, participating in the development of the risk assessment area. For 10 years Ms. Pineda was Manager of International Affairs on Drugs at (COFEPRIS), where she represented and coordinated COFEPRIS’ participation in international fora on drugs, medical devices, dietary supplements, cosmetics, toxic substances and pesticides, as well as developed cooperation agreements.