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.

Juliana Perlow is currently Executive Director at MSD, where she leads the International CMC - Latin America team. In this role, Juliana is responsible for leading the regional strategy and execution of regional CMC post-approval variations and initial registration submissions for both small molecules and large molecules, including biologics and vaccines. A pharmacist with specialization in clinical pharmacology and project management, she also has an MBA. Juliana has more than 25 years of experience in pharmaceutical industries working in regional regulatory CMC and regulatory affairs functions. Juliana co-chairs the ISPE Latin America Regulatory Quality Harmonization Committee.

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.

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 in ANVISA and industry, leading or contributing to bilateral and multilateral negotiations, harmonization and convergence initiatives. Specialized knowledge and activities in liaising with government agencies, international and regional organizations, industry and other stakeholders in the area of health regulation. Current role in Roche as Regulatory Policy Lead for Latin America.

Susan Koepke is an accomplished Regulatory Affairs professional with more than 25 years of experience in the pharmaceutical industry. With a background in industrial pharmacy and an MBA, she brings a unique blend of expertise to her role at EMD Serono Inc, the healthcare business of Merck KGaA, Darmstadt, Germany. As the Regulatory Affairs Head for Latin America, based in Miami, FL, USA, she spearheads the innovative pipeline delivery and oversees life cycle management activities for established products across the Latin American market. Her wealth of experience and leadership are instrumental in driving regulatory excellence while advocating for best science and evidence-based decision making regulatory framework.

Barbara Lopez Kunz served 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.

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 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 topics such as 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.

Pharmacist, with MBA and Masters in Public Health, with more than a decade focusing on regulatory strategies to strengthen health systems across the globe.

Jared R. Auclair, Ph.D. is currently the Interim Dean College of Professional Studies, 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. 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.

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.

Dr. David Martin works across therapeutic areas as the Head of the Patient Centered Clinical Outcomes Center of Excellence at Novartis. Previously, he led Global RWE at Moderna, with accountability for provision of enterprise real world data and analytics as well as oversight for deliverables oriented toward regulators, payers, providers, and patients. He retired as a Captain after completing 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 in the Center for Biologics. Subsequently, he established the RWE group to drive the agency's scientific, guidance, and submission review responses to the RWE provisions of the 21st Century Cures Act.

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.

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 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.

Bachelor in Pharmacy and Biochemistry with 27 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 in a transition role from Head of the Latin American regulatory hub team managing new product applications and the product lifecycle in the Pfizer Global Regulatory Science group.

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 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.

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).

Dr. Jaclyn Bosco Global Head of Epidemiology in Real World Solutions at IQVIA, is responsible for driving real-world evidence (RWE) generation for regulators, clinicians, patients and payers using passive and primary data collection through clinicians and person-generated health to support the safety and effectiveness of drugs, biologics, and medical devices from early clinical development through the post-approval phase. 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 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 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 Expedited Pathways group in EFPIA. 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.

+20 years’ of experience working in both the public & private sector of Regulatory Affairs (RA). Her career started at the MHRA - the UK RA & then moved into UK & EU regulatory strategy roles at both AZ & 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, managing diverse roles within Global & Regional functions at Pfizer. Ronnie’s responsibilities have included projects spanning labeling activities across EUCANZ, EME, AfME, Canada &LATAM. Currently a key focus for Ronnie is internally & externally leading on the topics of health literacy and ePI across LATAM, AFME, EU.

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 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.

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.