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
Registration CLOSED
PROGRAM (session times may change)
| MONDAY, NOVEMBER 2 | 13:00 to 16:00 ET LANDSCAPE OF PEDIATRIC MEDICINE IN CANADA & GLOBAL REGULATORY PATHWAYS | |
| 13:00 ET | Welcome / Introduction Dr. Co Pham Interim Executive Director of the Centre for Regulatory Excellence, Statistics and Trials (CREST), Biologics and Radiopharmaceutical Drugs Directorate, Health Canada |
| Opening Remarks Mr. Pierre Sabourin Assistant Deputy Minister, Health Products and Food Branch (HBFB), Health Canada | |
| 13:10 ET | Improving Medicines for Canadian Children: Promoting Innovation in a Changing Landscape Dr. Stuart MacLeod Professor of Pediatrics (Emeritus), University of British Columbia |
| 13:40 ET | Health Canada’s Pediatric Drug Action Plan Dr. Alysha Croker Manager, Office of Paediatrics and Patient Involvement, Health Canada |
| 14:05 ET | Pediatric Drug Regulation in the United States Dr. John Alexander Deputy Director, Division of Pediatric and Maternal Health, Center for Drug Evaluation and Research (CDER), FDA |
| 14:40 ET | Regulatory aspects of paediatric drug development in UK and Europe Dr. Angeliki Siapkara, Paediatric Unit Manager, MHRA (UK) |
| Break | |
| 15:15 ET | Live Panel Discussion Chair and Speakers |
| TUESDAY, NOVEMBER 3 | 13:00 to 15:00 ET PEDIATRIC CLINICAL TRIALS | |
| 13:00 ET | Welcome / Introduction Dr. Raimar Loebenberg Professor, Faculty of Pharmacy & Pharmaceutical Sciences, University of Alberta |
| 13:05 ET | Rare 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 ET | Clinical Trial Regulatory Modernization: What’s in it for pediatric research Dr. Carole Légaré Director, Office of Clinical Trials, Health Canada |
| 13:40 ET | Promoting Global Clinical Research in Children Guest Speaker: Dr. Barbara Bierer Faculty Director, Professor of Medicine, Harvard Medical School |
| Break | |
| 14:15 ET | Live Panel Discussion Chair and Speakers |
| WEDNESDAY, NOVEMBER 4 | 13:00 to 15:30 ET PEDIATRIC DATA EXTRAPOLATION | |
| 13:00 ET | Welcome / Introduction Dr. Catherine Lau Strategic Advisor, Janssen Canada |
| 13:05 ET | Pediatric 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 ET | Study Methodologies in Pediatric Trials Dr. Alex Bliu Senior Biostatistician, Health Canada |
| 13:50 ET | Pediatric 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. |
| Break | |
| 14:30 ET | Live Panel Discussion Chair and Speakers |
| THURSDAY, NOVEMBER 5 | 13:00 to 15:30 ET PEDIATRIC FORMULATIONS, ECONOMIC, PATIENT PERSPECTIVES & SPECIAL ACCESS PROGRAMME | |
| 13:00 ET | Welcome / Introduction Arshia Ghani Associate Director, Regulatory Affairs, Pfizer Canada |
| 13:05 ET | Oral Compounding for Pediatrics in Canada and at SickKids Karen Walsh Compounding Resource Pharmacist, The Hospital for Sick Children |
| 13:15 ET | Improving Access to Pediatric Formulations for Canadian Children Dr. Andrea Gilpin Goodman Pediatric Formulations Centre (GPFC) |
| 13:35 ET | How Patients/Parents Influence Pediatric Drug Development and Access Dr. Durhane Wong-Rieger President & CEO of the Canadian Organization for Rare Disorders (CORD) |
| Break | |
| 14:05 ET | Pediatrics 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) |
| 14:25 ET | Modernizing the Special Access Program for Drugs – Regulatory and Operational Changes Mr. Ian MacKay Manager, Special Access Program, Health Canada |
| Break | |
| 14:50 ET | Live Panel Discussion Chair and Speakers |
| Closing Remarks Dr. Celia Lourenco Director General, Health Canada | |
| Category | Fee |
| 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