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DIA Annual Canadian Meeting


Speakers

  • Marilena  Bassi, MA

    Marilena Bassi, MA

    • Director of the Bureau of Policy
    • Health Canada, Canada

    Marilena Bassi has been with Health Canada since 2004 where she has held various policy, evaluation and performance management related positions. Currently she is the Director of the Office of Planning, Performance and Review Services with the Therapeutic Products Directorate at Health Canada. Previous to her positions with Health Canada she worked at Justice Canada and Public Safety Canada in areas related social justice financial grants and contributions.

  • Deirdre  Cozier

    Deirdre Cozier

    • Director, Regulatory Labelling Advertising and Operations (Canada)
    • Pharmascience, Canada

    Deirdre has 20 years’ experience in the area of regulatory affairs. She has extensive experience in the preparation and management of Canadian drug submissions including Clinical Trial Applications, New Drug Submission and all related variations. She is also a recognized expert in health product advertising and regulatory operations. She has comprehensive knowledge of strategy development and execution and training and education and has presented at several major conferences over the years.

  • Loretta  Del Bosco

    Loretta Del Bosco

    • Director, Regulatory Affairs Quality Assurance Operations
    • AbbVie Corporation, Canada

    Loretta has spent several decades in the Canadian pharmaceutical industry and is the current Director, Regulatory Affairs, Quality Assurance and Operations, AbbVie Canada, the Vice-Chair of Canada’s Innovative Medicines Canada Regulatory Affairs Committee and member of BIOTECanada’s Subsequent Entry Biologics Committee and Biologics Regulatory Affairs Group. A member of the McGill University Faculty of Science Advisory Board and Microbiology and Immunology McGill graduate.

  • Laura  Durno, MS, MSc

    Laura Durno, MS, MSc

    • Acting Chief, Viral Vaccines Division
    • Biologics and Genetic Therapies Directorate, Health Canada, Canada

    Laura Durno worked as a Senior Evaluator at Health Canada for many years, reviewing pre and post-market quality submissions for biotherapeutic products. She has recently moved to Health Canada's Centre for Biologics Evaluation, where she manages the Viral Vaccines Division. Laura has a B.Sc. (Honours) in Life Science from Queen's University and an M.Sc. (Virology and Immunology) from the University of Ottawa.

  • Karen  Feltmate

    Karen Feltmate

    • President
    • Redstone Health Group, Inc., Canada

    Karen Feltmate is the President of Redstone Health Group Inc., a consulting firm providing regulatory strategy and guidance to the innovative Pharmaceutical industry. Karen has over 20 years of executive experience primarily in the area of Canadian Federal registration and also manufacturing, packaging, quality and distribution. Karen holds a B.Sc. in Biology from McMaster University. She is a past Board member of both the Canadian Pharmaceutical Distribution Network (CPDN) and the University of Toronto Biotechnology Bridging Program. She is a member of the Drug Information Association, and was a founding member of the Canadian Association of Professionals in Regulatory Affairs (CAPRA).

  • Lorella  Garofalo, PhD

    Lorella Garofalo, PhD

    • Director, Regulatory Affairs; Worldwide Safety and Regulatory-Innovative
    • Pfizer Canada Inc, Canada

    Lorella has been with Pfizer Canada since 2001 assuming roles of increasing responsibility in clinical research as well as medical affairs and is currently head of regulatory affairs for Pfizer’s Innovative business. She obtained a BSc (Honours) in Biochemistry and a PhD in Pharmacology & Therapeutics from McGill University. Prior to joining Pfizer, Lorella was a drug assessment officer at TPD, Health Canada and since 1999 has maintained an academic appointment with the department of Pharmacology & Therapeutics at McGill. She has served as a member of the board of directors/advisory councils for various research organizations and is a member of the regulatory affairs committees of Innovative Medicines Canada and BIOTECanada.

  • Maggie  Graham

    Maggie Graham

    • Senior Policy Analyst, Natural and Non-Prescription Health Products Directorate
    • Health Canada, Canada

    Maggie Graham joined Health Canada in 2005. She has held various positions in the areas of site licensing, good manufacturing practices and risk management as well as in the Director General’s Office as Senior Policy Analyst and Senior Advisor to the Director General. Maggie Graham has a Bachelor of Science (Honours) in Life Science and Bachelor of Education from Queen’s University.

  • Keith  McIntosh

    Keith McIntosh

    • Executive Director, Scientific & Regulatory Affairs
    • Innovative Medicines Canada, Canada

    Keith McIntosh is Executive Director, Scientific & Regulatory Affairs at Innovative Medicines Canada, and joined the organization in 2012. Previously, Keith spent 12 years in progressively senior policy and regulatory roles at another trade association. He has successfully advocated industry positions to federal, provincial and municipal departments and agencies covering a diversity of issues and topics. Keith has primary responsibility for the association’s interactions with Health Canada’s drug review bureaus, and developing the association’s positions on regulatory proposals and amendments. He also supports the work of the Regulatory Affairs and PMPRB committees, among others.

  • Marc F. Poitras, PhD, MBA

    Marc F. Poitras, PhD, MBA

    • Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau
    • Health Canada, Canada

    Dr. Poitras has worked at Health Canada in different capacities in Pharmacovigilance and drug safety for the last 9 years. His undergraduate and graduate training includes a BSc in Biotechnology and MSc/PhD degrees in Pharmacology from the University of Sherbrooke. He also completed post-doctoral training programs in cellular biology and neuroscience at Johns Hopkins University and New York University. He then completed a MBA at the University of Ottawa. Dr. Poitras is currently working as a Scientific Manager at the Marketed Health Products Directorate.

  • Matthew  Ryan

    Matthew Ryan

    • Senior Policy Analyst; Policy, Planning and International Affairs Directorate
    • Health Canada, Canada

    Matthew Ryan is currently a Senior Policy Analyst in the Strategic Horizontal Policy Division within the Policy, Planning and International Affairs Directorate (PPIAD) at the Health Products and Food Branch (HPFB). He recently held the position of Senior Advisor in the both the Assistant Deputy Minister’s Office and the Director General's Office of the Therapeutic Products Directorate. In addition, during his over ten years with Health Canada, he has held project management and policy positions in the Bureau of Cardiology, Allergy and Neurological Sciences, the Bureau of Pharmaceutical Sciences and the International Affairs Directorate within the Strategic Policy Branch (SPB).

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA, United States

  • Lisa  Chartrand

    Lisa Chartrand

    • Director, Regulatory Affairs and Quality Management
    • Hoffmann-La Roche Limited, Canada

    Lisa Chartrand began her 20 year career in the industry with Apotex as a quality assurance chemist and found her passion in Regulatory Affairs when she joined EMD Serono in 1999. At Roche Canada since 2003, she has enjoyed many growth opportunities in Regulatory Affairs and Medical Affairs and was appointed Director, Regulatory Affairs and Quality Management in 2014. Lisa is an active member of both Innovative Medicines Canada's Regulatory Affairs Committee and of BioteCanada's Biologics Regulatory Affairs Group (BRAG). Lisa earned her Bachelors of Science in Microbiology and Immunology from McGill University in Montreal, Quebec and holds a certificate from the Toronto Institute of Pharmaceutical Technology in Quality Assurance.

  • Rania  Gaspo, PhD

    Rania Gaspo, PhD

    • Director, Global Therapy Area Lead, External Medical Communications
    • Pfizer Canada Inc, Canada

    Rania Gaspo earned her Pharmacy Degree and her PhD at University of Montreal, Faculty of Pharmacy. She served as a Post-Doctoral fellow at Montreal Heart Institute before moving into industry in 1998 as a Senior Scientist within Merck Research Laboratories. Rania joined Pfizer in 2003 where she held positions in medical information, medical affairs and clinical development in various therapeutic areas. She also served as a guest speaker for 24 years at University of Montreal and gave lectures to students. In her current role Rania leads a team of Medical Information Managers within Neuroscience and Pain category leadership in US and Canada. Rania authored/co-authored peer-reviewed publications and scientific communications.

  • Nancy  Shadeed

    Nancy Shadeed

    • 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.

  • Mugdha  Chopra, DDS

    Mugdha Chopra, DDS

    • Associate Vice President, US PV and Clinical Safety
    • APCER Life Sciences, United States

    Mugdha Chopra is dentist by qualification and has over 14 years of experience in the field of dentistry, and Pharmacovigilance. She is Associate Vice President for US PV and clinical safety at APCER and oversees the delivery and operations from India which includes but not limited to case processing aggregate reporting, literature monitoring and signal detection. Before joining APCER, she was with Ranbaxy as a Manager in the department of Medical affairs and Pharmacovigilance. She comes with an extensive experience in various safety databases like Argus Safety and ARISg for case processing, reporting, and product/license management and has also met the challenges of business continuity planning and data restoration.

  • Leah  Christl, PhD

    Leah Christl, PhD

    • Associate Director for Therapeutic Biologics, TBBS, OND, CDER
    • FDA, United States

    Dr. Christl is the Associate Director for Therapeutic Biologics in the Office of New Drugs (OND) in the FDA's Center for Drug Evaluation and Research. Dr. Christl leads the Therapeutic Biologics and Biosimilars Staff (TBBS) in OND. TBBS is responsible for ensuring consistency in the scientific and regulatory approach and advice to sponsors regarding development programs for proposed biosimilar biological products and related issues regarding development programs for therapeutic biologics. TBBS is also responsible for developing scientific and regulatory policy as it relates to the review and approval of biosimilar products.

  • Basanti  Ghosh, PhD, MBA

    Basanti Ghosh, PhD, MBA

    • HPFB Marketed Health Products Directorate (OPEDA)
    • Health Canada, Canada

    Dr. Basanti Ghosh is the Director of the Office of Pharmacoepidemiology and Data Analytics (OPEDA) in the Marketed Health Products Directorate in Health Products and Food Branch. OPEDA has the mandate of building and maintaining capacity to provide pharmacoepidemiological and statistical advice to MHPD review staff. The Office also facilitates MHPD's access to real world surveillance research through the management of Drug safety and Effectiveness Network Program within HPFB.

  • Andrea  Gilpin, PhD, MBA

    Andrea Gilpin, PhD, MBA

    • General Manager
    • The Rosalind and Morris Goodman Family Pediatric Formulations Centre , Canada

    Andrea Gilpin is the General Manager of the Goodman Pediatric Formulations Centre. Dr. Gilpin began her career as a scientist and completed her Doctorate in Molecular Biology and Biochemistry from the University of Toronto. After obtaining her MBA, her career brought her through several different roles including working 12 years in small biotechnology companies in investor relations and communications. In 2011, she took a position working at Pfizer and later spent 5 as years working at Novartis, first as Head of Corporate Communications for Novartis Canada and second, in a marketing oncology position in the Lung and Melanoma franchise.

  • John  Groskoph, MBA

    John Groskoph, MBA

    • Executive Director, New Products CMC, Global CMC
    • Pfizer Inc, United States

    John Groskoph leads the New Products CMC function at Pfizer and has over 20 years of pharmaceutical industry experience. John has worked in a variety of regulatory, quality and production assignments and brings experience in Quality & Compliance Systems, clinical trial submissions through post-approval change management. John has a particular focus on bringing new technologies and new approaches through the CMC regulatory approval process. John holds a B.S. in Electrical Engineering from Lafayette College, Pennsylvania and an M.B.A. from Columbia University, New York, USA.

  • Mary  Hill

    Mary Hill

    • Manager, Policy Development, International Affairs
    • Health Canada, Canada

    Mary Hill serves as the Manager of the International Affairs, in the Health Products and Food Branch. She works with her colleagues on international initiatives. Mary previously served on Health Canada’s Secretariat for the International Coalition of Medicines Regulatory Authorities.

  • Laura  Johnson

    Laura Johnson

    • Project Manager Office of Planning, Performance and Review Services
    • Health Canada, Canada

    Laura Johnson received her Honour's Bachelor degree in Chemistry from the University of Ottawa. She joined Health Canada in 1995 as an officer responding to Access to Information requests, then held several positions related to submission management. Since 2003 Laura has been involved with the development and implementation of the Summary Basis of Decision (SBD) project. She currently manages the operational implementation of pre-market transparency initiatives and supervises the SBD technical writers in the Therapeutic Products Directorate, Health Canada.

  • Sophie  Lafrance

    Sophie Lafrance

    • Corporate Regulatory Compliance & Enforcement Advisor
    • Health Canada, Canada

    Sophie Lafrance has worked in federal regulations since 2005 when she joined Health Canada’s Health Products and Food Branch Inspectorate (now known as the Health Product Compliance Directorate, RORB). She is the national coordinator of the Good Pharmacovigilance Practices (GVP) inspection program since 2008. Her role is to support the delivery of Canada’s national GVP inspection program by providing support to inspectors for their inspections, assisting in resolving emerging issues arising from these inspections, liaising with the Marketed Health Products Directorate (MHPD), and contributing to the development of program regulations, policies, and guidelines.

  • Kelly  Lehman

    Kelly Lehman

    • Associate Director
    • Health Canada, Canada

    Kelly has extensive experience in a variety of science-policy interface roles with Health Canada. She is currently the Associate Director for the Bureau of Metabolism, Oncology and Reproductive Sciences.

  • Sanjeev  Miglani, MD

    Sanjeev Miglani, MD

    • Vice President-PV and Clinical Safety North America and Global Medical Affairs
    • APCER Life Sciences, United States

    Sanjeev is an MD in Internal Medicine and has more than 16 years’ experience in the field of Medicine, Pharmacovigilance and Clinical Research. He has held executive leadership positions in pharmaceutical companies and business process outsourcing firms with responsibilities for Pharmacovigilance, medical writing, medical affairs and Clinical research. Sanjeev was also Senior Resident in the Cardiology and Medicine Departments in renowned hospitals of New Delhi. Sanjeev is also a fellow of IACM

  • Andre  Molgat, DrSc, PhD

    Andre Molgat, DrSc, PhD

    • Senior Regulatory Affairs Officer, Resource MGMT and Ops Directorate, HPFB
    • Health Canada, Canada

    André Molgat is a Senior Regulatory Affairs Officer in the Health Products and Food Branch of Health Canada with scientific review responsibilities. He is a core member of the team responsible for Health Canada’s initiative on public release of clinical information. André has a PhD in biochemistry and post-doctoral training in biochemistry and stem cell biology.

  • Donald  Palmer, MA

    Donald Palmer, MA

    • Director, Product Strategy & Regulatory Informatics
    • ACUTA LLC, United States

    As the Director of Product Strategy and Regulatory Informatics, Donald is responsible for developing and validating product strategy and concepts, working with the design team to insure acceptance criteria are met, and liaising with Standards Development Organizations for future product directions.With a BA and MA in Mathematics, Donald became fully involved in the pharmaceutical industry just as electronic submissions were starting late in the 1990’s. His experience in the industry bridges the business and technology divide and spans Regulatory submissions, document management, and Regulatory Information Management, especially as they integrate with other departments and systems and is a strong proponent of standards

  • Anu  Shukla-Jones

    Anu Shukla-Jones

    • Senior Policy Analyst
    • Health Canada, Canada

    Anu has an interdisciplinary Bachelor of Science (Honours) from the University of Toronto and a Master of Science (Neuroscience) from the University of Ottawa. She has worked as a Laboratory Manager and Regulatory Policy and Risk Management Advisor in the Health Products and Food Branch of Health Canada. Anu is currently a Senior Policy Analyst in the Emerging Science Policy Unit in the Science Policy Directorate of the Strategic Policy Branch at Health Canada and is an Innovation Designer at the Health Canada-Public Health Agency of Canada's Innovation Hub.

  • Evelyn  Soo

    Evelyn Soo

    • Associate to the Director General, Biologics and Genetic Therapies Dictorate
    • Health Canada, Canada

    Evelyn Soo has been with Health Canada since 2009 where she has held various scientific and regulatory positions. She is currently the Associate to the Director General, Biologics and Genetic Therapies Directorate. Prior to joining Health Canada, she was a Research Officer at the National Research of Council Canada in Halifax, NS and led a metabolomics research program.

  • Daniel  Blackwood

    Daniel Blackwood

    • 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).

  • Alexandra  Chambers

    Alexandra Chambers

    • Director
    • CADTH, Canada

    Before joining CADTH’s pCODR in 2014, Ms. Chambers was a Clinical Epidemiologist with Health Quality Ontario and the Ontario Health Technology Advisory Committee (OHTAC). Ms. Chambers holds a Masters degree from McMaster University, and a Bachelor of Science (Hons) degree from the University of Waterloo.

  • Rocelyn  DelCarmen

    Rocelyn DelCarmen

    • Director, Regulatory Affairs and Quality Assurance
    • Astrazeneca Canada Inc., Canada

    Rocelyn DelCarmen has 19 years experience working at various Canadian innovative pharmaceutical companies working primarily in the Regulatory Affairs-Quality Assurance areas, in addition to exposure to the reimbursement and sales areas. Rocelyn sits on the Regulatory Affairs committees at BIOTECanada and Innovative Medicines Canada.

  • Yolande  Dufresne

    Yolande Dufresne

    • TORYS, LLP, Canada

    Yolande Dufresne’s practice focuses on the areas of intellectual property and food and drug regulatory law. Yolande advises clients with regulated products in the food, pharmaceutical, biotechnology and medical device industries, in areas including product licensing, labelling and advertising, product recalls and corrective actions, privacy, access to information and anti-spam matters. Yolande also advises on intellectual property and related transactions, including the acquisition, enforcement and exploitation of patents, trademarks, copyrights and industrial designs.

  • Hoda  Eid, PhD, MSc

    Hoda Eid, PhD, MSc

    • Manager, Office of Clinical Trials, Adverse Drug Reaction Division
    • Health Canada, Canada

    Hoda Eid holds a Ph.D. from the Université de Montréal in Canada and a Post-Doctoral fellowship from the Brigham and Women’s Hospital and Harvard Medical School in Boston. Dr. Eid’s career in research lead her to the development of a model to investigate cardiac cell regeneration that was later sought by more than 30 laboratories in the world, resulting in articles still being published confirming the earlier observations and the prospect of repairing the damage caused by a heart attack. She joined the government to establish and to take on the lead in 2006 of the pre-market safety surveillance of drugs in development in Canada.

  • Patrick  Fandja

    Patrick Fandja

    • Manager, Medical Devices Section
    • Health Canada, Canada

    Patrick Fandja has been with Health Canada since 2003 where he held various positions in regulatory area and scientific evaluation of health products. Currently, he is managing the team responsible for the post-market surveillance of medical devices within the Marketed Health Product Directorate at Health Canada. Patrick has a Master in Pharmaceutical Sciences from Université de Montréal, and MBA from Université de Québec à Montréal and Paris Dauphine

  • Joel  Finkle

    Joel Finkle

    • Director, Regulatory Innovation
    • ACUTA, United States

    Joel became embroiled in electronic submissions when regulatory came downstairs and asked "Can we convert all our reports into WordPerfect format for the FDA reviewer?" Since then, he's been involved with custom CANDAs, PDF publishing, eCTD, document template automation, Regulatory Information Management, HL7's RPS, and the ISO IDMP standard both within pharma companies and as a vendor/consultant. He joined ACUTA in April of 2017. He'd share some of his famous tomatillo salsa with you, but he can't carry it on airplanes.

  • Lucye  Galand, DVM, MBA, MSc

    Lucye Galand, DVM, MBA, MSc

    • Acting Director, BGIVD, Therapeutic Products Directorate, HPFB
    • Health Canada, Canada

    Although most of her regulatory career in Health Canada has been spent in the pharmacovigilance world, she has recently migrated to the pre-market assessment of pharmaceuticals program in the Therapeutic Products Directorate. Lucye has significant work and management experience in the Health Products and Food Branch (HPFB), where she has held a number of management positions in different Directorates. She is currently Acting Director of the Bureau of Gastroenterology, Infection and Viral Diseases. Her academic specialization is pharmacology.

  • Harry  Gewanter

    Harry Gewanter

    • Immediate Past Chair
    • Alliance for Safe Biologic Medicines, United States

    Dr. Harry L. Gewanter is the Immediate Past Chair of the Alliance for Safe Biologic Medicines (ASBM). A pediatric rheumatologist with over 3 decades of experience, he is an active member of the American College of Rheumatology, the American Academy of Pediatrics and the Arthritis Foundation, among others.A recipient of the ACR's Paulding Phelps Award he has also been an advocate on behalf of people with disabilities.

  • Patrick  Massad

    Patrick Massad

    • Deputy Commissioner
    • Pharmaceutical Advertising Advisory Board (PAAB), Canada

    Patrick Massad is the Deputy Commissioner at the Pharmaceutical Advertising Advisory Board (PAAB). He's been with the PAAB for over 15 years. He also continues to work as a community pharmacist. He graduated from University of Toronto with a degree in Pharmacy.

  • Christopher  McCabe

    Christopher McCabe

    • Executive Director & CEO
    • Institute of Health Economics, Canada

    "Dr. Christopher McCabe is the Executive Director and CEO of the Institute of Health Economics (IHE). He is a Professor of Health Economics at the University of Alberta, and having previously served as Professor of Health Economics a the Universities of Sheffield, Warwick and Leeds in the UK. Between 2011 and 2017, Dr. McCabe held a the Capital Health Research Chair at the University of Alberta. Between 2007 and 2011 he was Founding Director of the Academic Unit of Health Economics within the Leeds Institute of Health Science. He has worked extensively with public, private and non-for-profit stakeholders in the health care policy in UK, Europe, North America and Australasia."

  • Chris  Rose

    Chris Rose

    • Director, Cannabis Legalization and Regulation Branch
    • Health Canada, Canada

    Chris has over 20 years’ experience in the health product industry and health product regulation. Chris is currently the Director of Program Implementation with the Government of Canada’s Cannabis Legalization and Regulation Secretariat. Chris is the former Director of Operations for the Office of Medical Cannabis, the group responsible for the licensing and oversight of the commercial medical cannabis program and registrations for personal cultivation in Canada. Chris’ career has also included operational leadership positions in the Health Products and Food Branch of Health Canada in the areas of medical devices, drug inspection and compliance, in addition to positions in private industry and at the provincial healthcare level.

  • Vikesh  Srivastava

    Vikesh Srivastava

    • Associate Director, Business Informatics Division, HPFB
    • Health Canada, Canada

    Vik is responsible for the strategic and operational leadership of the HPFB IT investment plan and governance aimed to modernize and drive efficiencies within the regulatory program areas. Vik holds an Undergraduate Degree in Biochemistry & Finance from the University of Ottawa, second Undergraduate Degree in Computational Biology/Computer Science Graduate Degrees in Genomics & Computer Science from McGill University.

  • Kathleen  Barnard

    Kathleen Barnard

    • Save Your Skin Foundation, Canada

    Kathleen Barnard, Dip (ECCE) is the President of Save Your Skin Foundation. After completing her Diploma in Early Childhood Care and Education (ECCE) at Capilano University, Kathleen embarked on a career in business as a Corporate Accounting Manager, from which she moved on to be a Branch Manager for over a decade at Royal Bank of Canada. From there she moved into marketing and communications, as Stakeholder & Government Relations Manager at Insurance Corporation of British Columbia. She was the first woman to ever coach baseball in the Little League World Series. Kathy is also the recipient of the British Columbia Community Achievement Award for her leadership in addressing and raising awareness around skin cancer issues.

  • Patrick  Caines, PhD, MBA

    Patrick Caines, PhD, MBA

    • Senior Director, Quality & Compliance
    • Baxter Healthcare, United States

    Patrick Caines, Ph.D., MBA is Senior Director, Quality & Compliance, Baxter Healthcare where he is responsible for the company’s global quality systems and compliance and post market surveillance. Patrick has over 20 years experience in quality systems and compliance for both medical devices and in-vitro diagnostics and served as Director, Corporate Post market surveillance, Boston Scientific, and GE Healthcare and Quality Director and Director of World-wide Customer Quality at Johnson and Johnson. Patrick served on the FDA Cases for Quality where he led the post production team and is currently leading his company’s post market surveillance and quality alignment.

  • Cheryl  Cheung

    Cheryl Cheung

    • Intellectual Property Counsel
    • Pharmascience, Canada

    Cheryl Cheung is an intellectual property lawyer and currently leads the litigation group of the Intellectual Property Team at Pharmascience. She is a member of the bar in Ontario and Quebec (as a Canadian legal advisor), and is a non-practising member of the New York bar. Before joining Pharmascience, Cheryl practiced at a law firm specializing in intellectual property, where she worked on various pharmaceutical patent and regulatory matters such as providing legal opinions and litigating cases commenced under the Patented Medicines (Notice of Compliance) Regulations.

  • Caroline  Croteau, MS, RPh

    Caroline Croteau, MS, RPh

    • Country Safety Lead
    • Pfizer Canada Inc, Canada

    Caroline Croteau has been with Pfizer Canada since 1996 assuming roles of increasing responsibility in medical information as well as medical quality operations and is currently head of the Drug Safety Unit for Pfizer Canada, where she oversees local pharmacovigilance activities. She is a licensed pharmacist with previous experience in both hospital and community settings. Caroline is a graduate from Laval University, School of Pharmacy and is currently pursuing PhD studies in Medications and Population Health at University of Montreal, Faculty of Pharmacy.

  • Daniela I. Decina, MSc

    Daniela I. Decina, MSc

    • Senior Director, Regulatory Affairs, CMC
    • Mapi Group, Canada

    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.

  • Michael  Duong

    Michael Duong

    • Director, Evidence Generation, Medical Affairs
    • Hoffmann-La Roche Limited, Canada

    Michael is the Director for Evidence Generation in Medical Affairs for Hoffmann-La Roche Limited. In this role, Michael manages a team responsible for medical research in Canada, including clinical trials, real world data sciences, health outcomes research, and biostatistics. Prior to that, Michael led Health Economics at Roche in the Reimbursement and Health Economics Department. Earlier Michael spent three years in health care consulting, specializing in health economics and outcomes research, and medical communications. Michael received his undergraduate degree in Biology and Pharmacology and a Ph.D. in Medical Sciences with a specialization in Neuroscience, both from McMaster University.

  • Debra  Haltrecht

    Debra Haltrecht

    • Health Canada, Canada

    Debra Haltrecht is a Manager in the Office of Legislative and Regulatory Modernization, part of the Health Products and Food Branch at Health Canada. She is responsible for the development of a broad range of legislation and regulations covering drugs, biologics and medical devices, including Vanessa’s Law, emergency measures, assisted human reproduction and regulatory review. Debra has a Master of Business Administration from the University of Ottawa. She has worked for the Federal Government for 20 years in various capacities from research to program implementation to regulatory development.

  • Stephanie  Hardy, MPH, RAC

    Stephanie Hardy, MPH, RAC

    • OPIC, Biologics and Genetic Therapies Directorate, HPFB
    • Health Canada, Canada

    Stephanie Hardy joined Health Canada in 2003 and is currently a manager in the Office of Policy and International Collaboration within the Biologics and Genetic Therapies Directorate. Her unit is responsible for the development of policies and guidance documents to support the regulatory review of biologic drug submissions, including biosimilars. Ms. Hardy has a Master of Public Health degree from the University of Waterloo, a BSc. in Biomedical Toxicology from the University of Guelph, and is a graduate of Seneca College’s Pharmaceutical Regulatory Affairs and Quality Operations Post-Graduate Program.

  • Mai-Loan  Leha, MPharm, MSc

    Mai-Loan Leha, MPharm, MSc

    • Medical Information, Canada Lead
    • Bristol-Myers Squibb, Canada

    Mai-Loan Leha, B. Pharm., M. Sc. Mai-Loan graduated from University of Montreal in 1992. She obtained her Master degree in Hospital Pharmacy in 1994, affiliated to the Jewish General Hospital and worked in at the Montreal Children's Hospital until 1998. She joined the industry with various responsibility at Medical Information and Clinical Supplies for Bristol-Myers Squibb, Pfizer Canada, and Novartis Canada. She also obtained her license in Ontario as pharmacist in the 1990's. She is also currently working as a community pharmacist in Quebec as a part-time pharmacist and acting as clinical pharmacist affiliated to the University of Montreal and Laval University for interns.

  • Celia  Lourenco, PhD

    Celia Lourenco, PhD

    • Interim Senior Executive Director, Therapeutic Products Directorate
    • Health Canada, Canada

    Dr. Celia Lourenco is the Interim Senior Executive Director for the Therapeutic Products Directorate. She has been in management roles at Health Canada since 2007 and was until recently the director of the Bureau of Gastroenterology, Infection and Viral Diseases. She currently also represents Health Canada on the Management Committee of the International Council for Harmonization.

  • Kirsten  Mattison

    Kirsten Mattison

    • Director of Drug Policy and Science
    • Health Canada, Canada

    Kirsten Mattison holds a Bachelors degree from the University of British Columbia and a PhD from the Oregon Health and Science University. She joined Health Canada as a research scientist in 2005, and has worked as a director on regulatory files including food safety, pathogen security and, for the past three years, controlled substances.

  • Nick A. Orphanos

    Nick A. Orphanos

    • Senior Policy Analyst
    • Health Canada, Canada

    Mr. Nick Orphanos is a senior policy analyst with Health Canada, specializing in international affairs for drug regulation. Mr. Orphanos graduated from the University of Carleton in 2003 with a bachelor’s degree in Economics and joined Health Canada shortly after. Mr. Orphanos plays a key role in Health Canada’s membership at ICH as the ICH Coordinator while participating in the ICH Assembly and Management Committee activities. Mr. Orphanos currently also acts as the Secretariat for the International Pharmaceutical Regulators Forum (IPRF) and is also involved in Health Canada’s participation in the ACSS (Australia-Canada-Singapore-Switzerland) Consortium.

  • Refik  Saskin

    Refik Saskin

    • Institute for Clinical Evaluation Sciences (ICES), Canada

    Refik is a staff scientist with Data & Analytic Services and the Cancer Program at ICES Central. He completed a MSc in statistics at the University of British Columbia and a BSc in mathematics at Brock University. Refik has been at ICES since 2004, spending most of his time on health services research in cancer, including screening, treatment and end-of-life care. His current work with Data & Analytic Services focuses on facilitating research led by external investigators with a wide range of topics, including assessing cardiovascular events associated with a specific drug therapy, exploring healthcare utilization and costs associated with smoking.

  • Brooke  Casselberry, MS, RAC

    Brooke Casselberry, MS, RAC

    • Owner
    • Cyan Life Sciences, United States

    Brooke is a partner at IDENTIFICA focusing on Client Engagement and Regulatory Strategy. She has more than 15 years of experience in Life Sciences supporting industry clients in standards and process implementation, strategy, and business development. Brooke volunteers her time supporting networking communities like DIA and mentoring others in Regulatory for Life Sciences.

  • Andy  Hua

    Andy Hua

    • A/Sr. Regulatory Project Manager
    • Health Canada, Canada

    Andy Hua has been with Health Canada since 2003 and has worked in various regulatory, evaluation and operational positions. Andy recently joined the International Programs Division within the Therapeutic Products Directorate at Health Canada as a Senior Policy Advisor.

  • Alison  Ingham, PhD

    Alison Ingham, PhD

    • Team Leader, Generic Drugs Quality Division
    • Health Canada, Canada

    Alison Ingham obtained her B.Sc. (Chemistry and Biochemistry) at the University of the Witwatersrand in South Africa and her Ph.D. in Chemistry from the University of Victoria. She joined Health Canada and within the Therapeutic Products Directorate, she has worked in areas assessing Generic and New Drugs. Alison has been involved since 2004 with the Certification process at the European Directorate for the Quality of Medicines and Health Care, and was appointed as an external assessor by EDQM in 2006. She held the position of Manager of Product Assessment at the Natural Health Products Directorate for 5 years before returning to the Bureau of Pharmaceutical Sciences to her current position of Senior Advisor/Manager.

  •   Panel Discussion

    Panel Discussion

    • All Session Speakers, United States

  • Barry D Stein

    Barry D Stein

    • President and CEO
    • Coloretal Cancer Association of Canada, Canada

    Barry D. Stein is an attorney and member of the Barreau du Quebec since 1981. An accomplished lawyer and president of the Colorectal Cancer Canada, he actively represents the interests of cancer patients and speaks regularly to medical professionals, industry, government and patient groups across Canada and internationally. Barry is a survivor of metastatic colorectal cancer diagnosed in 1995 and was obliged to seek health care outside of Canada to fight his disease. His judgement, obtained in the Superior Court of Quebec, serves as a leading precedent for the reimbursement of out of country health care.

  • Elisabeth  Toller

    Elisabeth Toller

    • Health Canada, Canada

    Elizabeth Toller is the Director of Strategic and Horizontal Policy at Health Canada's Health Products and Food Branch. She is a seasoned policy wonk with over 10 years experience in social policy, particularly related to the health field. Elizabeth's current role is to help advance her organization's broad policy agenda, including its strategic goal of being a modern regulator.

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