VIRTUAL EDUCATION DAY 2020
July 7, 2020 9:00am to July 8, 2020 1:30pm EDT
VIRTUAL EDUCATION DAY 2020 is coming July 07 and July 08, 2020.
CAPRA continues to stay committed to providing education to our members and staying connected.
Due to COVID-19, this year will be different. This year is different in many ways for all of us, and the 2020 Education Day is no exception. This year the Education day will be a virtual session and planned as two half-day sessions. The format will consist of live webinars followed by a Q&A session.
| Tuesday, July 7, 2020 (9:00 am - 1:30 pm) | |
| Topic | Speaker(s) |
| Regulatory Enrolment Process - Tips for Drug Submissions and Clinical Trials | Joseph Mikhael, Manager, DSIM, OSIP, Resource Management and Operations Directorate, HPFB, Health Canada, and; Irena Pastorekova, Regulatory Affairs Supervisor, DSIM, OSIP, Resource Management and Operations Directorate, HPFB, Health Canada |
| Tips to Prepare Effective Risk Management Plans | Nadiya Jirova, Scientific Evaluator, Marketed Pharmaceuticals Bureau, MHPD, HPFB, Health Canada |
|
Management of Drug Submissions Policy (Including Pause the Clock Option) |
Heather Cherry, Regulatory Affairs Manager/ Special Projects, Regulatory Project Management Division, Office of Planning, Performance and Review Services, TPD, HPFB, Health Canada |
|
Tips for Effective Submissions (BRDD) |
Nabbiya Ahmed, Senior Regulatory Affairs Officer, Office of Regulatory Affairs, Centre for Regulatory Excellence, Statistics & Trials, BRDD, HPFB, Health Canada |
| Wednesday, July 08, 2020 (9:00 am - 1:30 pm) | |
| Topic | Speaker (s) |
| Cost-Recovery Framework | Michel Pariseau, Associate Director, Strategic Planning and Accountability Division, Health Canada, and; Maria Koulouris, Acting Manager, Service Fees Policy, Cost Recovery and Investment Planning, Chief Financial Officer Branch, Health Canada |
|
Collaborations with Health Technology Assessment |
Emile Geoffroy, Manager, PPSED, Office of Planning, Performance and Review Services, TPD, HPFB, Health Canada, and; Trevor Richter, Director of Pharmaceutical Reviews, Collaborations with Health Technology Assessment Review (CADTH) |
| International Collaborative Review Activities: Update on ACSS and Project Orbis | Caroline Healy, Policy and International Coordination Advisor, ORIRM, Centre for Regulatory Excellence, Statistics and Trials, BRDD, HPFB, Health Canada |
|
Update on Pharma Advertising and Marketing Practice |
John K. Wong, Director, Regulatory Drug Advertising & Promotion, TPIreg/Innomar Strategies |
*Registrants may be substituted, but no refunds will be issued after the deadline.
Please add your First name, Last name and the Email address that you will use to log in the day of the webinar.
Speakers / Panelists
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Joseph Mikhael
Manager, Division of Systems Management, HPFB
Joseph Mikhael
Manager, Division of Systems Management, HPFB
Health Canada
Joseph Mikhael, Ph.D. has worked at Health Canada since 2006 in various capacities, but all revolved around Information Management and Technology. Currently, he manages the Division of Systems Management, whose responsibility is to manage docuBridge as Health Canada’s official document repository, its related suite of Automator profiles, eCTD development and roll-out, and new eReview projects, such as the Regulatory Enrolment Process.
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Irena Pastorekova
Regulatory Affairs Supervisor, DSIM, OSIP, Resource Management and Operations Directorate, HPFB
Irena Pastorekova
Regulatory Affairs Supervisor, DSIM, OSIP, Resource Management and Operations Directorate, HPFB
Health Canada
Mrs. Irena Pastorekova is a Regulatory Affairs Supervisor at Resource Management and Operations Directorate. She has joined Submission and Information Policy Division in 2006 and after working with DIN unit, she was assigned to the division of system management unit. Her main responsibility is implementation of eCTD and non-eCTD format for submissions received by Health Canada. She works with external stakeholders to help with preparation of electronic submissions. She is responsible for management of the eValidator and the automation process of submission received via the gateway. She also provides support in the maintenance of the viewing tool, gateway, and participates in revisions to the Notices and Guidance documents for electronic submissions. She is a member of the ICH M8 working group.
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Nadiya Jirova
Scientific Evaluator, Marketed Pharmaceuticals Bureau, MHPD, HPFB
Nadiya Jirova
Scientific Evaluator, Marketed Pharmaceuticals Bureau, MHPD, HPFB
Health Canada
NadiyaJirovacomes to us from the MarketedHealth ProductsDirectorate (MHPD)where she has worked as a Scientific Evaluatorsince 2008 and has acted in the Manager position on multiple occasions.During her carrier at MHPD, she worked on many high profile filesincluding numerous risk management plansand represented HealthCanada during expert advisory committees.She is the chair of the signaldetection working group that is responsible for screening documentssubmitted by Market Authorization Holders.Nadiya has aBachelor’sdegree in Biochemistry, with a minor in Pharmacology, from McGillUniversity and a Master’s degree in Pharmaceutical Sciences withspecialization in Drug Development from the University of Montreal
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Heather Cherry
Regulatory Affairs Manager/ Special Projects, Regulatory Project Management Division, Office of Planning, Performance and Review Services, TPD, HPFB
Heather Cherry
Regulatory Affairs Manager/ Special Projects, Regulatory Project Management Division, Office of Planning, Performance and Review Services, TPD, HPFB
Health Canada
Heather Cherry is currently a Regulatory Affairs Manager assigned to Special Projects, at Health Canada in the Regulatory Project Management Division of the Therapeutic Products Directorate. Heather has a Bachelor of Sciences in Medicinal Chemistry from the University of Ottawa. She has been with Health Canada since 2008, first as a Regulatory Project Manager supporting the Bureau of Cardiology, Allergy and Neurological Sciences, then as Senior Regulatory Project Manager supporting the Bureau of Pharmaceutical Sciences. She has been in her current role since September 2018. Heather participated in the development of the Cost Recovery regulatory changes, and in the Pause the Clock Working group which contributed to the recent updates to the Guidance Document: Management of Drug Submissions and Applications.
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Nabbiya Ahmed
Senior Regulatory Affairs Officer, Office of Regulatory Affairs, Centre for Regulatory Excellence, Statistics & Trials, BRDD, HPFB
Nabbiya Ahmed
Senior Regulatory Affairs Officer, Office of Regulatory Affairs, Centre for Regulatory Excellence, Statistics & Trials, BRDD, HPFB
Health Canada
Nabbiya Ahmed has been part of the Office of Regulatory Affairs (ORA) at the Biologics and Radiopharmaceutical Drugs Directorate (BRDD) since 2016. Ms. Ahmed is currently a Senior Regulatory Affairs Officer within the Monoclonal Antibodies Unit at ORA. Previously, she was involved with the Vaccines, Radiopharmaceutical and Gene Therapies Unit and with the annual updates of seasonal influenza vaccines. Having served in project management and supervisory capacity at ORA, she possesses strong regulatory knowledge and expertise of these products regulated by the BRDD.
Prior to joining ORA, she was involved in compliance and enforcement activities within the Consumer Product Safety Program at Health Canada. Ms. Ahmed holds a Hons. Bachelor of Science from the University of Toronto and subsequently obtained her Regulatory Affairs and Quality Operations certification (RAQC) from Seneca College.
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Michel Pariseau
Associate Director, Strategic Planning and Accountability Division
Michel Pariseau
Associate Director, Strategic Planning and Accountability Division
Health Canada
Michel Pariseau worked in the Office of the Comptroller General at TBS from 2016 to 2019, during which time he led the development of a new legal and policy framework governing the administration of fees across government. He was the policy lead behind the Service Fees Act, the Low-materiality Fees Regulations, and the revised Directive on Charging and Special Financial Authorities. Michel acquired his expertise on fees and cost-recovery having worked at Transport Canada, the Canadian Food Inspection Agency and Health Canada for over 10 years. His experiences on the front lines provided him with an understanding of how the governance around fees could be improved. He is currently on assignment at Health Canada.
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Maria Koulouris
Acting Manager, Service Fees Policy, Cost Recovery and Investment Planning, Chief Financial Officer Branch
Maria Koulouris
Acting Manager, Service Fees Policy, Cost Recovery and Investment Planning, Chief Financial Officer Branch
Health Canada
Maria has been an employee of the public service for over 13 years and has worked as an analyst in various departments including Health Canada, the Public Health Agency of Canada and the Royal Canadian Mounted Police. She holds a Bachelor of Arts with a double major in Political Science and European and Russian Studies. As the Senior Policy Analyst on the Cost Recovery Team in the Resource Management and Operations Directorate, of the Health Products and Food Branch, Maria supported the policy development of Cost Recovery and led the development of the Small Business Strategy. Currently, Maria is working at the Chief Financial Officer Branch, in Health Canada as the Acting Manager for the Service Fees Policy Group in the Cost Recovery and Investment Planning Directorate.
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Emile Geoffroy,
Manager, PPSED, Office of Planning, Performance and Review Services, TPD, HPFB
Emile Geoffroy,
Manager, PPSED, Office of Planning, Performance and Review Services, TPD, HPFB
Health Canada
Emile is currently the manager of the Planning, Performance and Stakeholder Engagement division within the Therapeutic Products Directorate (TPD) of Health Canada. In addition, he is the Health Canada lead on the HTA alignment initiative. Emile has several years of experience in regulatory affairs with TPD, in both the generic and innovative pre-market drug space. He has also worked in intellectual property with the Office of Patented Medicines and Liaison at Health Canada. Emile holds a master’s degree in neurobiology from McGill University.
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Trevor Richter
Director of Pharmaceutical Reviews, Collaborations with Health Technology Assessment Review (CADTH)
Trevor Richter
Director of Pharmaceutical Reviews, Collaborations with Health Technology Assessment Review (CADTH)
Health Canada
Dr. Trevor Richter is the Director of Pharmaceutical Reviews at CADTH. He has worked at CADTH for the last nine years with a focus on managing clinical reviews of pharmaceuticals. Prior to joining CADTH, Dr. Richter was involved in various forms of clinical research for more than a decade, both as an academic researcher and in the pharmaceutical industry. He has an MSc in physiology and a PhD in neuroscience from Cambridge University.
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Caroline Healy
Policy and International Coordination Advisor, ORIRM, Centre for Regulatory Excellence, Statistics and Trials, BRDD, HPFB
Caroline Healy
Policy and International Coordination Advisor, ORIRM, Centre for Regulatory Excellence, Statistics and Trials, BRDD, HPFB
Health Canada
· Caroline Healy is a Policy and International Coordination Advisor in the Office of Regulatory Intelligence and Risk Management (ORIRM), which hosts Secretariat functions and coordination activities for international work sharing initiatives.
· She holds an MSc. in Biology, a certificate in Project Management and also completed a Graduate Diploma in Population Health Risk Assessment and Management at the Faculty of Medicine of the University of Ottawa.
· She has been with Health Canada for over 18 years and has worked on a wide range of projects, issues and activities, including toxicological research, project management, risk assessment and communication for consumer products, establishment licensing, drug shortages, opioid crisis, orphan drugs, antibiotic resistance and emergency access to drugs under the Special Access Programme.
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John K. Wong
Director, Regulatory Drug Advertising & Promotion
John K. Wong
Director, Regulatory Drug Advertising & Promotion
TPIreg/Innomar Strategies
John is a pharmacist graduate from Université Laval, Québec. He started his career at the Toronto General Hospital as a Clinical Pharmacist in Oncology and Nutrition Support. He later joined the Pharmaceutical Advertising Advisory Board (PAAB), the national regulatory body for prescription drug advertising, and became the Deputy Commissioner / Chief Review Officer in 2001. After 10 years at PAAB, John decided to cross over to the ‘other side' and worked at Ogilvy CommonHealth as an Account Director where he helped launch specialty products into the Canadian market in Oncology, Urology, Hematology, HIV and Immunology (vaccines). John has a unique background from both the regulatory and marketing sides of drug advertising and he is currently the Director, Regulatory Drug Advertising & Promotion at TPIreg/Innomar Strategies in Canada.
Payment Options
The two options for payment are as follows:
- Credit card payment online
- Third-party payment via credit card
Please note: Under the new incorporated CAPRA, credits for meetings can no longer be issued. In order to attend a meeting, payment must be received prior to the meeting registration deadline. Registrants for whom payment has not been received will be refused entry to the meeting.
Process
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