Latin America Regulatory Conference
Maria Guazzaroni Jacobs, PhD
- Director, Quality and Regulatory Policy (QRP), 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, Australia
- 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.
- Director, Regulatory Affairs-CMC, GRACS CMC – Latin America
- MSD, Brazil
Juliana Perlow has aproximately 20 years of experience in local and multinational pharmaceutical companies working with regualtory affairs and regional CMC functions.
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
Cammilla Horta Gomes, MA, MPharm
- LATAM Regulatory Policy Lead
- Roche, Brazil
Specialist in Global Health and Health Regulation, with a Master’s Degree in Development and International Cooperation. Broad experience in regulatory policy, both as regulator and industry, leading or contributing to bilateral and multilateral negotiations, harmonization and convergence initiatives. Specialized and policy activities include: working within WHO, PAHO, Mercosur, ICH, IPRP, IMDRF, ICMRA, UNODC, and industry associations; liaising with government agencies, industry and other stakeholders in the area of health regulation; organization of and institutional representation in information sharing events. Currently working in Roche as a Regulatory Policy Lead for Latin America.
Susan Koepke, MBA
- Head of Regulatory Affairs LATAM
- EMD Serono, Inc., United States
Susan Koepke is a Regulatory Affairs professional with 25 years of experience in pharmaceutical industry. She works for EMD Serono Inc, as the Regulatory Affairs Head for Latin America based in Miami, FL, USA . EMD Serono Inc. is part of Merck KGaA, headquartered in Germany, a leading science and technology company operating across healthcare, life science and performance materials. Within the healthcare division, she is responsible for innovative pipeline delivery as well as for life cycle management activities of established products in Latin America. Besides her passion and commitment to improve patients lives she is a proud mother of two kids and a black lab who fill her life with joy and meaning.
- LatAm Regulatory Affairs Policy Manager
- Novartis, United States
Barbara Lopez Kunz, MBA, MS, MSc
- Global Chief Executive
- DIA, United States
Barbara Lopez Kunz serves as President and Global Chief Executive of DIA, driving thought leadership and innovation in therapeutic development to improve the health of people worldwide. She previously served as President of Health and Life Sciences at Battelle, one of the world’s largest, most respected R&D organizations. She has also served as Senior Vice President/General Manager for Thermo Fisher Scientific’s Biosciences Division, as SVP for DuPont, and head of R&D for ICI. A dedicated volunteer for children's health, Barbara chairs the board of Children's National Research Institute, serves as advisor to the UC I4H Fellowship, and as Director for Aptevo Therapeutics.
Roberta Mele Mazza, RPh, RAC
- Q&RA Manager, División Diagnóstica
- Productos Roche , Argentina
Pharmacist with more than years working in Regulatory Affairs specialized in Medical Devices on multinational companies. Wide experience working in policies that enable patients have access to the best technologies.
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.
Fernanda Lessa, MBA, MPH
- Reg Affairs Specialist, Health Systems/Services and Medicines and Health Tech
- Pan American Health Organization (PAHO), 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.
Hugo Hamel, MBA, MSc
- Manager, Radiopharmaceuticals and Monoclonal Antibodies Division
- Health Canada, Canada
Mr. Hamel spent his last 20 years working with the Biologic and Radiopharmaceutical Drugs Directorate (BRDD), where he is currently Division Manager of the Radiopharmaceuticals and Monoclonal Antibodies (Inflammation) Division. During his career 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 Q12 IWG and leads its implementation in Canada.
David Martin, MD, MPH
- Vice President, Pharmacovigilance
- Moderna, United States
David Martin leads pharmacovigilance globally across the entire pipeline for Moderna. Previously he completed 20 years of active duty service split between the United States Air Force and Public Health Service. At the FDA he led the Division of Epidemiology which assessed benefits and risks for vaccines and other products regulated by the Center for Biologics. Subsequently, he led the Real World Evidence Staff in the Office of Medical Policy and reviewed all submissions containing real world evidence intended to demonstrate the effectiveness of drugs or biologics regulated by the Center for Drug Evaluation and Research. He is also the originator of the open-source FDA MyStudies mobile application.
Patricia Aprea, MD
- Director, Evaluation and Control of Biológicals/Research
- 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 IVD department
- ANMAT, Argentina
Kourtney J. Davis, PhD
- Senior Director and Head, Therapy Area Matrix, Global Epidemiology
- Janssen R&D, LLC, United States
Dr. Kourtney Davis is currently Senior Director and Therapy Area Matrix Lead for Global Epidemiology at Janssen R&D, where she leads a team of 20+ epidemiologists aligned to therapy areas (CNS, Immunology, CV/Met, Oncology, ID/Global Public Health/Vaccines, and Pulmonary Hypertension) designing and delivering RWE to inform medicine development. Dr. Davis has more than 20 years experience leading global teams and epidemiologic research programs, with a strong focus on generating RWE for regulatory decision making. She is the Chair of the Publications and Communications Committee for ISPE and adjunct assistant professor at UNC-Chapel Hill. Dr. Davis earned a MSPH and PhD in epidemiology from the UNC- Chapel Hill.
- Manager, Global Regulatory Affairs – Translational Medicine & Devices
- EMD Serono, Inc, United States
Manager, Global Regulatory Affairs Translational Medicines & Devices department at EMD Serono with experience in product registration activities for medical devices & combination products and global regulatory requirements management. She has more than 10 years’ experience in regulatory affairs activities. Prior to her move to the US, she held local and regional positions in Latin America with experience in regulatory strategy for both new applications and life-cycle management activities. She holds a Pharmacy degree from J. F. Kennedy University, Argentina.
- Head of the Regional Regulatory Hub Latin America
- Pfizer, United States
Bachelor in Pharmacy and Biochemistry with 22 years of practice in the Pharmaceutical industry. Developed his career holding responsibilities in Quality Assurance, Clinical Trial and Regulatory Affairs. Former Regulatory head of Eli Lilly and Pfizer Peruvian subsidiaries. Worked as Regulatory Strategist for the Emerging Markets at Pfizer Inc. New York Head Quarters. Current Head of the Latin American regulatory hub team managing new product applications and the product lifecycle in the Pfizer Global Product Development Division.
Renata De Lima Soares
- Regulation and Health Surveillance Specialist
- Anvisa, Brazil
Renata is pharmacyst with more than ten years of experience in Regulation and Health Surveillance. Graduated from the University of Brasilia in Pharmaceutical Sciences, post graduated in Forensic Sciences and specialized in Principles and Practices of Clinical Research (PPCR) by Harvard University. Experience in multiple areas of regulation and health surveillance such as Economic Regulation of Medicines, Therapeutic Equivalence, Assessoring oF Anvisa Director’s Board and others. She is Health and Regulation Expert from ANVISA and works in the present as Safety and Efficacy Assessment Manager for synthetic medicines in the Agency.
Dwight Abouhalkah, MBA, MSc
- Director, Americas Policy Lead
- Johnson and Johnson, United States
Dwight has over twenty-five years of global quality assurance, research and development, regulatory policy and regulatory compliance experiences in medical devices, pharmaceuticals, and combination products. Dwight started his professional career with the U.S. Food and Drug Administration (FDA) as a Consumer Safety Officer where he conducted audits of drug, device and biologics firms. Dwight also worked for FDA’s Center for Devices and Radiological Health in the Office of Compliance. Dwight has worked at Johnson & Johnson for over fourteen and has held leadership roles in the Pharmaceutical, Medical Device and Consumer businesses in the areas of Regulatory Policy, Quality Assurance, Regulatory Compliance and Research and Development.
- Director, Pharm Science Technology and Innovation
- Pfizer Inc, United States
Daniel O. Blackwood is a Director, Technology & Innovation, within PharmaTherapeutics Pharmaceutical Sciences at Pfizer. He received his BS in Mechanical Engineering from Cornell University in Ithaca NY, and his MS in Industrial Engineering from Columbia University in New York City. Currently, he is the technical program lead for Pfizer’s Portable, Continuous, Miniature, and Modular (PCM&M) development and manufacturing initiative for Oral Solid Dosages (OSD).
Jaclyn Bosco, PhD, MPH
- Senior Director, Global Scientific Head, Epidemiology and Outcomes Research
- IQVIA, Real World Solutions, United States
Dr. Jaclyn Bosco is the Global Head of Epidemiology and Outcomes Research in Real World Solutions at IQVIA. With her practical experience leading observational and low-intervention research studies in North America, Europe, and Asia-Pacific regions, she develops strategies for using non-interventional study methods for real-world evidence generation to support the safety and effectiveness of drugs, biologics and biosimilars, and devices. She identifies the best approach for capturing data on a global scale as well applies local approaches to address market-specific needs. As a thought leader in real world research, she is invited to speak at international congresses and sits on scientific advisory boards and committees.
Michelle Limoli, PharmD, RPh
- Senior International Health Science Advisor, Office of the Director, CBER
- FDA, United States
Michelle Limoli is the Senior International Health Science Advisor in FDA’s CBER. She is responsible for coordinating and collaborating on activities and strategic programs with various international organizations and governments, as well as within the CBER. During her career at FDA, she has coordinated activities in various harmonization and multilateral initiatives such as ICH, VICH, ICCR, GHTF, IMDRF, APEC RHSC, OECD, and WHO. Michelle joined CBER after having worked in the Center for Drug’s international programs, and the Office of the Commissioner, where Michelle served as the Director of FDA’s Europe Office. Michelle is a clinical pharmacist with both hospital and community pharmacy experience.
Rebecca Lumsden, PhD
- Director, Regulatory Policy and Intelligence
- Pfizer Inc, United Kingdom
Rebecca is a Director in the Pfizer Global Regulatory Policy and Intelligence group. Focus areas include expedited and reliance approval pathways, regulatory system strengthening and evolving standards of evidence especially in International regions. Prior to joining Pfizer in 2017, she was Head of Science Policy at the UK Trade Association (ABPI) and has worked on numerous policy issues relevant to the biopharmaceutical industry during her 8 years there. She is a Co-Chair of the FIFARMA’s Regulatory and Biologics Working Group and a member of the Advanced Therapies Working Group in IFPMA. She was a post-doctoral scientist prior to her career in policy, with a PhD from Fitzwilliam College, University of Cambridge (UK) in cell signalling.
Ronnie Harprit Mundair
- Regional Labelling Head - AfME, Canada and LATAM - Senior Director
- Pfizer, United Kingdom
+20 years of experience working in both the public & private sector of Regulatory Affairs within the pharmaceutical industry. Her career started in the Post-Licensing Division at the MHRA - the UK Regulatory body, shifting into UK & EU regulatory strategy roles at both AstraZeneca then Pfizer. In each of these roles she gained valuable experience across multidisciplinary aspects of RA ranging from Strategy, Labelling, CMC, Submissions, Artwork to Clinical Trials. In 2009, Ronnie moved into Labeling, responsible for managing diverse roles within Global & Regional functions at Pfizer. Her responsibilities have included both internal and external roles & projects spanning labeling activities across EUCANZ, EME, AfME, Canada and LATAM.
Carl P Denny, MS, MSc
- Sr. Director - Regulatory Affairs
- Avexis, Inc., United States
Current Position: - Senior Director, Regulatory Affairs for AveXis, Inc. (A Novartis-Owned Company) Education: - B.S. and M.S. Degrees in Chemisty (Illinois State and Purdue University) - US FDA Regulatory Affairs Certification (RAC) Experience: - Regulatory Affairs (U.S., International, CMC) – 20 years (Eli Lilly & Company, Abbott Laboratories, Takeda Pharmaceuticals, GE Healthcare, AveXis, Inc.) Currently overseeing: - Regulatory strategy development across portfolio - Zolgensma® - US, Japan & Geographic expansion activities - Zolgensma® - Post-approval & life-cycle mgmt. activities
Charles Preston, MD, MPH, FACPM
- Advisor, Regulatory System Strengthening for Medicines & Other Health Technology
- Pan American Health Organization (PAHO), United States
Charles Preston is a board certified preventive medicine and public health physician. He is an advisor on regulatory system strengthening at PAHO/WHO and based in Washington, DC. Prior to his work with PAHO, he was a medical officer at FDA.
- Directorate of Medical Devices and Other Technologies
- INVIMA, Colombia
Nicole Ennis, MSc
- Head Medicines Quality Control and Surveillance Department
- Caribbean Public Health Agency, Jamaica
Nicole Ennis is the Head of the Medicines Quality Control and Surveillance Department, the Jamaica campus of the Caribbean Public Health Agency. She has extensive experience in the implementation of laboratory quality and safety systems from her previous role as Quality/Safety Manager. She holds a BS Biology from Yale University and an Erasmus Mundus MS Quality Management of Laboratories from Gdansk University of Technology. Nicole is responsible for the management and maintenance of the Department’s ISO/IEC 17025 accredited testing services for medicines to verify their quality and efficacy. She also leads the Department in its collaborative work with regional partners to develop and strengthen policies for medicines regulation.
- Director Nacional de Medicamentos
- Director Nacional, El Salvador
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