Canadian Society for Pharmaceutical Sciences
Société canadienne des sciences pharmaceutiques


Pediatric Workshop (Virtual)

Evolving Landscape of Pediatric Medicine in Canada

NOVEMBER 2-5, 2020 (via Zoom)

The goal of the workshop is to exchange scientific viewpoints between the different stakeholder of industry, academia and the regulator. The past CSPS / Health Canada workshops were the nucleus for new regulatory initiatives and updates.

SESSION TOPICS INCLUDE:

  • Day 1: Landscape of Pediatric Medicine in Canada & Global Regulatory Pathways
  • Day 2: Pediatric Clinical Trials
  • Day 3: Pediatric Data Extrapolation
  • Day 4: Pediatric Formulations, Economic, Patient Perspectives & Special Access Programme

WORKSHOP FORMAT

  • Held over four half days (see program below)
  • Comprise a pre-recorded presentation, live panel discussion and Q&A with the speakers
  • Presentation available online two days in advance of the live discussion for those not able to attend the full session
  • On the day of the workshop, the session will be replayed, followed by the live portion.
  • Submit question in advance or live during the workshop

SPONSORSHIP

Interested in being a workshop sponsor?  We have sponsorship opportunities available

Register now

PROGRAM (session times may change)

MONDAY, NOVEMBER 2 | 13:00 to 16:00 ET

LANDSCAPE OF PEDIATRIC MEDICINE IN CANADA & GLOBAL REGULATORY PATHWAYS
Chair:  Dr. Stuart MacLeod, Professor of Pediatrics (Emeritus), University of British Columbia

13:00-13:05 ETWelcome / Introduction
Dr. Co Pham
Interim Executive Director of the Centre for Regulatory Excellence, Statistics and Trials (CREST), Biologics and Radiopharmaceutical Drugs Directorate, Health Canada
13:05-13:10 ETOpening Remarks
Mr. Pierre Sabourin
Assistant Deputy Minister, Health Products and Food Branch (HBFB), Health Canada
13:10-13:35 ETImproving Medicines for Canadian Children: Promoting Innovation in a Changing Landscape
Dr. Stuart MacLeod
Professor of Pediatrics (Emeritus), University of British Columbia
13:35-14:05 ETHealth Canada’s Pediatric Drug Action Plan
Dr. Alysha Croker
Manager, Office of Paediatrics and Patient Involvement, Health Canada
14:05-14:35 ETGlobal Regulatory Pathways
Dr. John Alexander
Deputy Director, Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research (CDER), FDA
14:35-15:05 ETRegulatory aspects of paediatric drug development in UK and Europe
Dr. Angeliki Siapkara, Paediatric Unit Manager, MHRA (UK)
15:05-15:10 ETBreak
15:10-16:00 ETLive Panel Discussion
Chair and Speakers
TUESDAY, NOVEMBER 3 | 13:00 to 15:00 ET

PEDIATRIC CLINICAL TRIALS
Chair: Dr. Michael Rieder, Professor, Department of Pediatrics, Physiology and Pharmacology and Medicine, Schulich Medicine & Dentistry, Western University

13:00-13:05 ETWelcome / Introduction
Dr. Raimar Loebenberg
Professor, Faculty of Pharmacy & Pharmaceutical Sciences, University of Alberta
13:05-13:25 ETRare Disease Therapeutics in Children: We Already Know How to Determine Benefit and Harm
Dr. Bruce Carleton
Professor and Division Chief, Division of Translational Therapeutics, Department of Pediatrics, Faculty of Medicine, University of British Columbia
Director, Pharmaceutical Outcomes Programme, BC Children’s Hospital
Senior Clinician Scientist, BC Children’s Hospital Research Institute
13:25-13:50 ETClinical Trial Regulatory Modernization: What’s in it for pediatric research
Dr. Carole Légaré
Director, Office of Clinical Trials, Health Canada
13:50-14:10 ETPromoting Global Clinical Research in Children
Guest Speaker: Dr. Barbara Bierer
Faculty Director, Professor of Medicine, Harvard Medical School
14:10-14:15 ETBreak
14:15-15:00 ETLive Panel Discussion
Chair and Speakers
WEDNESDAY, NOVEMBER 4 | 13:00 to 15:30 ET

PEDIATRIC DATA EXTRAPOLATION
Chair: Dr. Robert (Skip) Nelson, PhD, Senior Director, Pediatric Drug Development at Johnson & Johnson

13:00-13:05 ETWelcome / Introduction
Dr. Catherine Lau
Strategic Advisor, Janssen Canada
13:05-13:30 ETPediatric Extrapolation and ICH E11A: Two Decades in the Making
Dr. Lynne Yao
Director, Division of Pediatric and Maternal Health, Office of New Drugs, Center for Drug Evaluation and Research (CDER), FDA
13:30-13:50 ETStudy Methodologies in Pediatric Trials
Dr. Alex Bliu
Senior Biostatistician, Health Canada
13:50-14:20 ETPediatric Extrapolation and Case Studies
Dr. Janelle Burnham
Clinical Director, Pediatric Center of Excellence, Global Products Development, Pfizer Inc. and
Dr. Edress Darsey
Clinical Director, Pediatric Center of Excellence, Global Products Development, Pfizer Inc.
14:20-14:25 ETBreak
14:25-15:30 ETLive Panel Discussion
Chair and Speakers
THURSDAY, NOVEMBER 5 | 13:00 to 15:30 ET

PEDIATRIC FORMULATIONS, ECONOMIC, PATIENT PERSPECTIVES & SPECIAL ACCESS PROGRAMME
Chair: Mr. David Lee, Chief Regulatory Officer, Assistant Deputy Minister’s Office, Health Canada

13:00-13:05 ETWelcome / Introduction
Arshia Ghani
Associate Director, Regulatory Affairs, Pfizer Canada
13:05-13:25 ETOral Compounding for Pediatrics in Canada and at SickKids
Karen Walsh
Compounding Resource Pharmacist, The Hospital for Sick Children
13:25-13:45 ETImproving Access to Pediatric Formulations for Canadian Children
Dr. Andrea Gilpin
Goodman Pediatric Formulations Centre (GPFC)
13:45-13:50 ETBreak
13:50-14:10 ETHow Patients/Parents Influence Pediatric Drug Development and Access
Dr. Durhane Wong-Rieger
President & CEO of the Canadian Organization for Rare Disorders (CORD)
14:10-14:30 ETPediatrics and Health Technology Assessment (HTA)
Dr. Nicole Mittmann
Chief Scientist and Vice-President of Evidence Standards, Canadian Agency for Drugs and Technologies in Health (CADTH)
14:30-14:50 ETHealth Canada’s Special Access Program (SAP) Regulations and Modernization
Mr. Ian MacKay
Manager, Special Access Programme, Health Canada
14:50-15:00 ETBreak
15:00-15:40 ETLive Panel Discussion
Chair and Speakers
15:40-15:45 ETClosing Remarks
Dr. Celia Lourenco
Director General, Health Canada


REGISTRATION FEES

CategoryFee
CSPS Members
(Membership will be verified)
$200
Non-CSPS members$300
Trainees (students/postdocs)$100
Academic/Government Employees$150
Health Canada/FDA/MHRA$0

Email: csps@intertaskconferences.com
Tel: 613-238-4870