Latin America Regulatory Conference
- Unit Chief, Medicines and Health Technologies
- Pan American Health Organization (PAHO), United States
- International Relations Specialist, OIP, OGROP
- FDA, United States
Maria Guazzaroni Jacobs, PhD
- Director Quality and Regulatory Policy (QRP), Pfizer Global Supply
- Pfizer Inc, United States
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.
Maria Cristina Mota Pina, MBA
- Director, Regulatory Policy and Intelligence -Japan, Emerging Markets and Austra
- AbbVie, Inc., United States
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 Padua, MSc, RPh
- Associate Director GRA CMC Regulatory Intelligence Biopharam Global Regulatory
- EMD Serono, Switzerland
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).
Ana Patricia Pineda, MSc
- International Regulatory Analyst, OIP, OGROP, OC
- US FDA, Mexico
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 new cooperation instrum
- Regulatory Affairs Sr. Manager
- Amgen, Brazil
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.
- Senior Director,Latin America Area Head, Regulatory International
- Abbvie, United States
Sonia Viejobueno, LLM
- Latin America Lead, Global Regulatory Policy and Intelligence
- The Janssen Pharmaceutical Companies of Johnson & Johnson, Argentina
Sonia has over 15 years of professional legal, health policy and regulatory policy experience in the Latin American biopharmaceutical industry. As legal counsel specialized in commercial, business and corporate law, she has provided extensive legal advice to pharmaceutical companies in the region, including pharmaceutical law, intellectual property, business transactions, regulatory matters and corporate healthcare compliance, among others. She joined Johnson & Johnson in 2016 as Latin America Lead for Global Regulatory Policy & Intelligence. 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.
Patricia Aprea, MD
- Director, Evaluation and Control of Biológicals and R
- ANMAT, 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.
- Head of the General Office of Drug Products - GGMED
- ANVISA, Brazil
- Senior Advisor, Centre for Biologics Evaluation, BGTD
- Health Canada, Canada
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.
- Regulation and Health Surveillance Specialist
- ANVISA, Brazil
Michael Havert, PhD
- Senior Director Regulatory CMC
- bluebird bio, United States
Mike has been a CMC Reviewer in the Gene Therapy Branch since 2004. Gene Therapies are a diverse group of new technologies that include genetically modified viruses and cells. Mike’s recent accomplishments include serving as BLA 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 and conducted postdoctoral fellowships at JHU and NIH.
- Regulatory Affairs Manager - LATAM
- Novo Nordisk, Brazil
Thomas Schreitmueller, DrSc
- Global Head Regulatory Policy; F. Hoffmann - La Roche Ltd.
- F. Hoffmann - La Roche AG, Switzerland
Juliana Schwarz Rocha
- Regulatory Affairs Consultant
- NG Reis Consultoria, Brazil
- Manager, International Affairs Division, Therapeutic Products Directorate
- Health Canada, Canada
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.
Patrick Brady, PharmD
- Vice President, Regulatory Affairs Head, Regulatory Policy and Intelligence
- Bayer AG Pharmaceuticals, Germany
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 Long, MEd, MSc
- Senior Regulatory Officer, Integrated Development, Global Health
- Bill and Melinda Gates Foundation, United Kingdom
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.
Rosana Miguel Messias Mastellaro, RPh
- Director of Regulatory Affairs
- Sindusfarma, Brazil
Pharmacist, she has worked for 17 years in the pharmaceutical industry. Specialist in Project Management. She is currently Director of Regulatory Affairs at Sindusfarma . Since 2008 is responsible for the Pharmacovigilance area. Responsible for the coordination of several seminars and symposiums and for the elaboration of a Manual of Good Practices of Pharmacovigilance Sindusfarma in 2010 to assist in the orientation, training and compliance of sanitary regulations.
Frank Montgomery, PhD
- Global Head Regulatory CMC, GRAPSQA
- AstraZeneca, United Kingdom
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.
Ana Carolina Morieroa Marino Araujo, PharmD
- Head of the Office of Inspections and Fiscalization of Medical Devices
- Agência Nacional de Vigilância Sanitária (ANVISA), Brazil
- Associate Director for International Affairs, CDRH
- FDA, United States
Jared Auclair, PhD
- Associate Teaching Professor and Director
- Northeastern University, United States
Jared R. Auclair is an associate teaching professor in the department of chemistry and chemical biology at Northeastern University. In addition, Dr. Auclair is the Director of Biotechnology and Bioinformatics, as well as the Director of the Biopharmaceutical Analysis Training Laboratory, and of APEC and ICH training programs. These latter appointments allow Dr. Auclair to collaborate with both academic researchers, industry and government in the area of biopharmaceutical development and analysis. He has expertise in mol. biology, protein biochemistry, analytical chemistry, protein crystallography, and biological mass spectrometry.
- Head of Latin America, Worldwide Safety & Regulatory-Innovative
- Pfizer Inc, United States
Andrea Best, DO, MPH
- Executive Medical Director
- AbbVie, Inc., United States
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.
Leah Christl, PhD
- Executive Director, Global Regulatory and R&D Policy
- Amgen, United States
Dr. Christl is currently an Executive Director of Global Regulatory and R&D Policy at Amgen. Prior to joining Amgen, Dr. Christl served as the Associate Director for Therapeutic Biologics in the Office of New Drugs in the U.S. FDA's Center for Drug Evaluation and Research and was also the director of the Therapeutic Biologics and Biosimilars Staff at FDA. Dr. Christl is a scientific, regulatory, and policy expert on biosimilar products and a strategist and lead for international activities related to biosimilars and other policy areas. Dr. Christl received her PhD in Molecular and Cellular Biology and Pathobiology – Marine Biomedicine and Environmental Science from the Medical University of South Carolina in Charleston.
Hugo Hamel, MBA, MSc
- Senior Evaluator / Biologics and Genetic Therapies Directorate
- Health Canada, Canada
Mr. Hamel spent the last 18 years working with the Biologics and Genetic Therapies Directorate (BGTD) at Health Canada as Senior Evaluator with the Monoclonal Antibodies Division. He also acted for a year as Division Chief of the Radiopharmaceuticals and Gene Therapies Unit and as Division Chief of the Monoclonal Antibodies Division. Based on his extensive experience with the review of post-approval changes, Mr. Hamel was nominated to represent 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 will provide an overview on how to apply the principles of these WHO guidelines.
Jacqueline Kline, PhD
- Regulatory Affairs Director
- Amgen, Inc., United States
Jacqueline Kline is a Senior Director of Global Regulatory Affairs at Eisai Inc. She earned her doctorate in Bioengineering from Clemson University and has 20 years of experience in the pharmaceutical industry. At Eisai, she works with international project teams to develop strategies for the global development of drugs and biologics from clinical introduction through registration and post-marketing.
- Senior Director QA Audit and Compliance
- AbbVie, United States
Denise Bonamici, MSc
- Head of Regulatory Science and Policy - LATAM
- Sanofi, Brazil
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.
- Health Regulatory Expert,Post-approval's Office Small Molecules Drug Products
- ANVISA, Brazil
- Coordinator, Regulatory Systems Strengthening, EMP
- World Health Organization (WHO), Switzerland
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.
Reina de Acosta
- Directora Nacional
- Direccion Nacinal de Medicamentos, El Salvador