Menu Back toSpeakers

DIA Annual Canadian Meeting


Speakers

  • Marilena  Bassi, MA

    Marilena Bassi, MA

    • Director, Therapeutic Products Directorate
    • 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

  • 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.

  • Andrea  Gilpin, PhD, MBA

    Andrea Gilpin, PhD, MBA

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

  • 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.

  • 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."

  • 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

  • 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

  • Evelyn  Soo

    Evelyn Soo

    • A/Manager
    • Health Canada, Canada

  • Kathleen  Barnard

    Kathleen Barnard

    • Save Your Skin Foundation, Canada

    "Kathleen Barnard, Dip (ECCE), President, 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 for over a decade. 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. "

  • Cheryl  Cheung

    Cheryl Cheung

    • Intellectual Property Counsel
    • Pharmascience, Canada

  • 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.

  • 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.

  • Patrick  Fandja

    Patrick Fandja

    • Manager, Medical Devices Section
    • Health Canada, Canada

  • Joel  Finkle

    Joel Finkle

    • Director, Regulatory Innovation
    • ACUTA, United States

    Joel Finkle is Solution Lead, IDMP within CSC Life Sciences. In this role he brings new technologies and regulatory data standards to CSC’s pharmaceutical customers to ensure compliance and process improvements. Currently, this involves integrating IDMP (Identification of Medicinal Products) into our products and services. He has been reporting and advising on IDMP for three years, and has over 30 years in the Pharmaceutical industry, both at sponsor and vendor companies.

  • 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

    • Chairman
    • Alliance for Safe Biologic Medicines, United States

    Dr. Gewanter is a pediatric rheumatologist and current chair of ASBM. A graduate of Duke University and Wayne State University School of Medicine, he received his pediatric and rheumatology training at the University of Rochester/Strong Memorial Hospital. He has practiced in Richmond, VA and was the first Walter Bundy, Jr Professor of Community Pediatrics at Virginia Commonwealth University and the first pediatrician to receive the Paulding Phelps Award from the American College of Rheumatology.

  • 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.

  • Chris  Rose

    Chris Rose

    • Director, Cannabis Legalization and Regulatory 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.

  • 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.

  • Michelle  Boudreau

    Michelle Boudreau

    • Director General, Natural Health Products Directorate
    • Health Canada, Canada

  • 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.

  • Stephanie  Hardy, MPH, RAC

    Stephanie Hardy, MPH, RAC

    • Health Canada, Canada

  • Mai-Loan  Leha, MPharm

    Mai-Loan Leha, MPharm

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

  • Ed  Morgan

    Ed Morgan

    • Director General, Policy, Planning and International Affairs Directorate, HPFB
    • Health Canada, Canada

    Ed Morgan is the Director General of the Policy, Planning and International Affairs Directorate in the Health Products and Food Branch of Health Canada. In this position, Ed oversees regulatory policy development for health products and food, and provides strategic advice on advancing horizontal health policy and international agendas. Before joining Health Canada, Ed was Director of Operations for the Operations Committee of Cabinet at the Privy Council Office. Prior to, he was Chief of Staff to the Deputy Clerk of the Privy Council, and has held various other positions over the years in the federal government. Ed holds a Bachelor of Arts and an LL.B.

  • Nick A. Orphanos

    Nick A. Orphanos

    • Policy Analyst
    • Health Canada, Canada

  • 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.

  • Andy  Hua

    Andy Hua

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

  •   Panel Discussion

    Panel Discussion

    • All Session Speakers, United States

Contact us