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.

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.

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).

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.

Sr. Regulatory Affairs Manager in Amgen, Bachelor in Pharmacist and Biochemistry (University of Sao Paulo, 2006), MBA (Fundacao Getulio Vargas, 2012) with 16 years history of working in the biotechnology and pharma industry. Currently working at Amgen in Brazil since 2012. Past companies: Sanofi, Janssen, Novartis and Schering-Bayer.

Sonia has over 15 years of professional experience in the biopharmaceutical industry. As legal counsel specialized in commercial, business, and corporate law, she has provided extensive legal advice to pharmaceutical companies in the Latin America region, including pharmaceutical law, intellectual property, business transactions, regulatory matters and healthcare compliance. She joined Johnson & Johnson in 2016 as Latin America Lead for Global Regulatory Policy & Intelligence and later expanded her role to cover U.S. policy work on Cell & Gene Therapies. She holds a Master of Laws degree on International Trade Law from the University of South Africa and a Law degree from the University of Buenos Aires, Argentina.

Director of Evaluation and Control of Biologic and Radiopharmaceutical Products-ANMAT. She studied biochemistry at the Buenos Aires University where she was assistant professor and researcher of the Biochemistry and Pharmaceutical Industries career. She has technical background for more than 25 years in regulatory science with emphasis in research, control and evaluation of biologic and radiopharmaceutical products. She coordinates the Sub-Committee for Biologic Products, Argentine Pharmacopeia. She is member of the Interministerial Commission on Advanced Therapies and she has participated as member of severals programs of the Ministry of Science Technology and Productive Innovation.

Daniela graduated in Biological Sciences from the University of Brasilia (2002) and completed her PhD in Molecular Biology in the University of Brasilia (2007). Specialization in Health Surveillance by FIOCRUZ, in 2010. Currently, Daniela is the specialist in health surveillance of the National Health Surveillance Agency (Anvisa), with the position of Deputy Director for Director Alex Campos, in the Third Board of Anvisa. She acted as Manager of Biological Products Office at Anvisa from 2014 to 2018.

Ariel E. Arias MD, PhD, FISPE Senior Advisor - Biologics and Genetic Therapies Directorate Health Canada. Dr. Arias has many years of experience in the drug regulatory assessment pre- and post-approval. He has worked on the development & implementation of various drug regulatory initiatives, and has represented Health Canada in various international technical committees (e.g., ICH, PAHO). Dr. Arias is also a professeur associé at the Faculty of Pharmacy of the Université de Montréal, an active member of the Signal Panel at the Uppsala Monitoring Centre, and a former North America Government/Regulatory Board representative of the International Society for Pharmacoepidemiology.

Mike was trained as a virologist and has experience in the development of genetic medicines for the treatment of rare diseases and cancer. Mike recently worked at the CMC/regulatory interface for HSCT gene therapy programs at bluebird bio. Prior to his current position, Mike served as a reviewer in the Gene Therapy Branch at the FDA from 2004-2019. Mike’s accomplishments at FDA include serving as licensing Chair for a genetically modified autologous T-cell immunotherapy and championing the release of new Gene Therapy guidance documents. Prior to joining FDA, Mike received a Ph.D. from the University of Wisconsin, conducted postdoctoral fellowships at Johns Hopkins University and National Institutes of Health.

Nancy holds an Honours Bsc. in Biology from Brock University. Nancy was part of a team that worked on the renewal and implementation of the medical devices regulations in Canada in 1998. She is currently working with the International Programs Division. This division is responsible for managing international projects for both pharmaceuticals and medical devices. Nancy is currently working on medical device related projects, such as the medical device single audit program (MDSAP) and the Regulated Products Submission (RPS). Nancy was involved with the Global Harmonization Task Force for Medical Devices since 1999, participating as a member and later chair of Study Group 1 and the chair of the IVD subgroup.

Dr. Patrick Brady is Vice President, Regulatory Affairs at Bayer. In this role, he leads Bayer’s global regulatory policy and intelligence activities. He has more than 10 years of experience in Regulatory Affairs. Prior to joining Bayer, Patrick led international science and regulatory advocacy efforts across the pharmaceutical industry while working for the U.S. industry trade association, PhRMA. Dr. Brady completed his Doctor of Pharmacy degree at the University of Kansas in May 2003.

Raj is currently a Senior Regulatory Officer at the Bill & Melinda Gates Foundation (BMGF) responsible for Malaria and Neglected Diseases medicines portfolio. In 2014 Raj was invited by the UK Secretary of State to be a member to the World Dementia Council (WDC) she is also appointed by the UK Government as Director, Integrated Development to lead innovative approaches in the regulatory development of clinically relevant therapies for dementia.

Pharmacist, She is currently Director of Technical Regulatory Affairs and Inovation at Sindusfarma. She has worked for 17 years in the pharmaceutical industry. Specialist in Project Management. She acts in defense of the pharmaceutical industrial sector and coordinates regulatory convergence issues including Pharmacovigilance. She is a member of the Brazilian Pharmacopoeia Management Committee and is responsible for the interface with Anvisa representing associated companies.

Frank Montgomery was awarded his PhD in Synthetic Organic Chemistry at Imperial College London and completed Post Doctoral studies at Ohio State University. He then moved to Ciba Central Research in Discovery Chemistry then to AstraZeneca Process R&D. Frank led the Process R&D team for AstraZeneca’s project in the FDA’s CMC pilot program for implementation of ICH Q8, leading subsequent consultations with PMDA, EMA & Health Canada. Frank moved from a technical role to Regulatory Affairs and is now Global Head Regulatory CMC for small and large molecules across AstraZeneca/Medimmune. He is a member of ICH Expert Working Group as EFPIA Expert for ICH Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.

Head of the Inspections and Law Enforcement Office at the Brazilian Health Regulatory Authority (Anvisa) for the last 2 years. Anvisa's employee for 16 years with experience in assessing medicinal products, management position in the office of variations of medicinal product, and inspections of medicines and medical devices. Actively involved in international initiatives for the last 10 years, such as IPRP, ICH, PICs and IMDRF. Acts as Anvisa's ICH Coordinator for 7 years. Graduated in Pharmaceutical Sciences from the University of Brasília (2002), postgraduate in Health Surveillance from Oswaldo Foundation (2009) and postgraduate in Pharmaceutical Technology from the Fluminense Federal University (2012).

Jared R. Auclair, Ph.D. is currently the Vice Provost Research Economic Development and Director of Bioinnovation in the Office of the Provost at Northeastern University. As Vice Provost Research Economic Development, Dr. Auclair works to strengthen the bonds between our education and research missions by strengthening the integration of work-integrated credentialed learning and use-inspired research, co-creating with communities and partners while expanding our global mindset. As Director of Bioinnovation, Dr. Auclair works to leverage important University activities around biotechnology, bringing together experts from a wide range of disciplines and backgrounds to advance the expansion of Northeastern life sciences programs.

Dr. Andrea Best is an Executive Medical Director in Pharmacovigilance and Patient Safety at AbbVie in the suburbs of Chicago where she is responsible for Clinical Trial Safety Excellence and International Product PV. Andrea has over 20 years of experience in academia and industry across a variety of roles (clinical development, medical affairs and pharmacovigilance) and spanning numerous therapeutic areas including oncology, immunology, anti-infectives, renal, anesthesia, general medicine and devices. She has led discussions with global regulatory authorities on a variety of issues and has participated on several external collaborations related to regulatory system strengthening and pharmacovigilance in developing countries.

Dr. Leah Christl is Executive Director, Global Biosimilars Regulatory Affairs and Regulatory and R&D Policy at Amgen. She serves as head of the global regulatory affairs team within GRAAS with responsibility for development and execution of global regulatory strategy for Amgen’s biosimilars portfolio. Dr. Christl also leads the global biosimilars regulatory and R&D policy with responsibility to develop and advance Amgen’s policy positions. Prior to joining Amgen, Dr. Christl served as the Director of the Therapeutic Biologics and Biosimilars Staff at the US FDA. Dr. Christl received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina.

Mr. Hamel spent his last 23 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD) at Health Canada as Senior Evaluator and Division Manager. He is currently Associate Director with BRDD. Mr. Hamel was involved with reviewing the CMC information pertaining to CTAs, NDSs and Post-Marketing changes associated with Biotherapeutics and represented Health Canada on the WHO drafting group in charge of developing the WHO Guidelines on procedures and data requirements for changes to approved biotherapeutic products. Mr. Hamel is also a member of the ICH M4Q EWG and ICH Q12 IWG and leads its implementation in Canada. He is pleased to share his experience with the ICH Q12 pilot program in Canada.

Jackie Kline has worked in pharmaceutical and biotech research and development for over 25 years and currently serves as Vice President of Global Regulatory Affairs Oncology at Amgen. With a comprehensive understanding of global regulatory requirements, approval pathways and an aptitude for strategic planning, Jackie has helped to secure approvals and to advance development of new medicinal products in oncology, neurology, anesthesia, and metabolic therapeutic areas. She has led teams from early to late development, through post launch, and throughout lifecycle management. Jackie earned a BS in Mechanical Engineering from the University of Maryland College Park and a PhD in Bioengineering from Clemson University.

More than 20 years of experience in Regulatory Affairs setting regulatory strategies and managing a diverse portfolio. She is member of major Industry Associations and has a network of strong relationships with Regulatory Agencies. In her role as Head of Regulatory Science & Policy LATAM, Denise helps Sanofi advance regulatory science and strategically influence regulatory policy. Denise is a Pharmacist and holds a MSc in “Pharmaceutical Sciences” from the University of São Paulo.

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.