CAPRA

DATE OF MEETING TITLE AND LINK TO FILE / DOWNLOAD
June 2020 Webinar

1. Assessment of GMP compliance/remote GMP Inspections during the COVID-19 pandemic.

Speaker: Kim Godard, Director, Health Product Inspection and Licensing, Health Product Compliance, Regulatory Operations and Enforcement Branch

2. Management of Clinical Trials during the COVID-19 pandemic. 

Speaker: Dr. Daniel Keene, Senior Medical Officer and Manager, Office of Clinical Trials for Biological Agents, Biologics and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch

April 2020 Webinar

The Evolving US Regulatory Environment; major takeaways from 2019.

Speaker: Linda Bowen, MSc, RAC, FRAPS
Head of Regulatory Policy and Intelligence, Seattle Genetics

November 2019 Dinner Meeting

New Draft PMPRB Guidelines – Impact on Drug Pricing in Canada

Speaker: Kimberly Robinson, Director, Pricing & Market Access, leads the pricing and data analytics team at PDCI Market Access. 

October 2019 Webinar

Compliance Under CEPA – What’s New And What You Need to Know

Speaker: Michele Richardson, B.Sc., MBA, Regulatory Affairs, Environmental

June 2019 Annual CAPRA Education Day 2019

Agenda
1. Role of Regulatory Affairs Globally
2. Health Technology Assessments Aligned between HC and HTA Organizations
3. International Work Sharing
4. Cost Recovery Fees in Respect of Drugs and Medical Devices
5. Update on Health Product Inspections and Licensing
6. Personalized Health Care – Cell and Gene Therapies
7. Strategies for Filing Efficient Submissions
7.a. Strategies for Filing Efficient Submissions_APPENDIX 1 - Batch Analysis Table
7.b. Strategies for Filing Efficient Submissions_APPENDIX 2 - Post NOC Quality Chart
7.c. Strategies for Filing Efficient Submissions_APPENDIX 3 - Screening Report
8. Submissions Relying on Third Party Data (from a Regulatory Perspective)
March 2019 Dinner Meeting/Webinar

Health Canada’s Special Access Program (SAP)

Speaker:  Dr. Co Pham , Associate Director, 
Special Access Program in the Office of Clinical Trials, Therapeutic Products Directorate at Health Canada.

June 2018 Dinner Meeting

ICH Q12 – Challenges, Opportunities … and more Challenges.  

Speaker: Anthony Ridgway, Ph.D. Senior Regulatory Scientist
Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics
Biologics and Genetic Therapies Directorate

April 2018 Webinar

Regulatory considerations for rare disease drug development – A global perspective.

Speaker: Sathya Ganesan, PhD, RAC 
Regulatory Affairs Manager, PPD

March 2018 Dinner Meeting

Updates on Health Canada’s discretionary authority to disclose CBI under paragraph 21.1(3)(c) of the Food and Drugs Act and regulatory proposal to permit public release of clinical information.

Speaker: Marcin Boruk, Policy Analyst, RMOD, Health Products and Food Branch

November 2017 Webinar

Regulation of Cosmetics in Canada and Overview of the Self Care Framework.

Speakers:
Caroline Payette, Senior Regulatory Policy and Risk Management Advisor, Consumer Product Safety Directorate, Health Canada
and 
Maggie Graham, Senior Policy Advisor, Natural and Non-Prescription Health Products Directorate, Health Canada

October 2017 Webinar

Overview of the Canadian Cannabis Market's Evolution

Speakers:
Nick Antoniadis, Principal, Nick Antoniadis Consulting
Alex Revich, Educator, Cannabis in Clinical Practice

June 2017 Annual CAPRA Education Day 2017

6. (S)NDS Screening Report

We are providing the following items which were not available for inclusion on the USB sticks at the 2017 CAPRA Education Day. 

4. Presentation - A. Moir & M. Brown.
May 2017 Webinar

The EU Clinical Trials Regulation – Main Changes and Challenges

Speaker: Carla Gomes
Regulatory Affairs Senior Manager, PPD

April 2017 Dinner Meeting

Regulatory Roles and Issues in Corporate Transactions

Speaker: Teresa Reguly, Partner, Torys LLP

January 2017 Dinner Meeting

Health Canada’s pharmacovigilance activities for marketed pharmaceutical products: from signal detection to safety assessment and selection of risk mitigation strategy.

Speaker: Nadiya Jirova, M.Sc. Acting Manager Scientific Section 3
Marketed Pharmaceuticals and Medical Devices Bureau/Bureau des Produits Pharmaceutiques et des Matériels Médicaux Commercialisés
Marketed Health Products Directorate/Direction des Produits de Santé Commercialisés

November 2016 Dinner Meeting

Post-NOC Changes – Quality Guidance - overview and update

Speaker: Krishnan Tirunellai, Ph. D. Senior Scientific Advisor, Bureau of Pharmaceutical Sciences
Therapeutic Products Directorate, Health Canada

November 2016 Symposium Day 2

1. Veronica Yip
2. Rocelyn DelCarmen
3. PLL Case Study Workshop Plenary Session
November 2016 Symposium Day 1

1. Michelle Remillard
2. Dr. Jan Sedgeworth
3. Martin Bernard and Amy McDonald
4. Jerry Phillips
November 2016 Webinar

Supplemented Foods – A Growing Trend in Canada

Speaker: Jennifer Barber, Acting Section Head, Bureau of Nutritional Sciences, Food Directorate
Speaker: Lindsay Lukeman, Scientific Evaluator, Bureau of Nutritional Sciences, Food Directorate

October 2016 Webinar

ISO 13485, MDSAP: practical considerations for changes

Speaker: Nancy Ruth and Cathie Rutt
Director, Medical Devices/ Assoc Director, Medical Device Quality

June 2016 Annual CAPRA Education Day

1. Rachael Manion
2. Derrick Barnes
3. Jennifer A. Davies
4. Christelle Gedeon
5. Julie Robert
6. Doreen Clark Steen
7. Honorata Zurakowski
8. Maxime Sasseville
June 2016 Webinar

Canadian Licensing of Veterinary Drugs and Vaccines

Speaker: Mỹ (pronounced as May) Dang Regulatory Affairs, Animal Health Boehringer Ingelheim (Canada) Ltd

May 2016 Dinner Meeting

Health Canada update on pre-market transparency for drugs and devices.

Speaker: Laura Johnson, SBD Project Manager, Therapeutic Products Directorate (TPD), Health Canada.

April 2016 Dinner Meeting

Regulatory Framework for Subsequent Entry Biologics (SEBs) in Canada.

Speaker Toronto: Bradley Scott, Ph.D.
Speaker Montreal: Ally Pen, Ph.D.

March 2016 Webinar

Implementing Quality by Design in Clinical Trials

Speaker: Vatché Bartekian President & Founder Vantage BioTrials, Inc.

January 2016 Webinar

Compliance under CEPA: What you need to know. An Update on the Management of new and existing substances under the New Substances Notification Regulations and Chemicals Management Plan.

Speaker:Michele Richardson Director, Regulatory Affairs, Environmental, Mapi Life Sciences (Canada) Inc.

January 2016 Dinner Meeting

Patent Listing and Data Protection: A Primer for Regulatory Affairs Professionals

Toronto Speaker: Nancy Pei, partner in the Toronto office of Smart & Biggar. 
Montreal Speaker: Daphne Lainson,partner in the Ottawa office of Smart & Biggar.

November 2015 Webinar

Blurring Lines: Cosmetics and Drugs

Speaker: Robert Ross-Fichtner, President and CEO Focal Point Research Inc.

October 2015 Dinner Meeting

Submissions Relying on Third Party Data

Speaker: Dr. Jan Sedgeworth, PhD, Vice President, Intrinsik Health Sciences Inc.

June 2015 Webinar

YBPR – History and Practical Application

Speaker: Martin Nemec Senior Biologist/Evaluator Monoclonal Antibodies Division Centre for Biologics Evaluation Biologics and Genetic Therapies Directorate

June 2015 Annual CAPRA Education Day: June 9, 2015

1. Joy Bregg (Health Canada)
2. Maggie Graham (Health Canada)
3. Lorella Garofalo (Pfizer Canada Inc.)
4. Michelle Remillard (Health Canada)
5. Marcin Boruk (Health Canada)
6. Timothy Squire (Fasken Martineau)
7. Anne Tomalin (Therapeutic Products Inc.)
8. Lisa Galassi (Brand Institute) Jerry Phillips (Brand Institute)
May 2015 Webinar

Requirements for Manufacturing, Importing, Marketing, and Selling Cosmetic Products in Canada

Speaker: Kimberly Liska Consumer Product Safety Officer Regions and Programs Bureau Health Canada / Government of Canada

 

Q & A's
March 2015 Webinar

The BGTD Lot Release Program – The Current State of Affairs

Speaker: Sherri Boucher A/Senior Biologist/Evaluator Influenza and Hepatitis Vaccines, Viral Vaccines Division, Centre for Biologics Evaluation, Biologics and Genetic Therapies Directorate (Health Canada)

 

Q & A's
January 2015 Dinner Meeting

Bill C 17 Enacted by Parliament - A New Chapter in Canadian Drug and Medical Device Enforcement?

Speaker: Timothy Squire, Partner, Fasken Martineau LLP, Chair, International Life Sciences Group

December 2014 Webinar

Regulatory Information Management and IDMP - Craig Anderson

Speaker: Craig Anderson Q's and A's

October 2014 Dinner Meeting

Changes to the Guidance Document: Reconsideration of Decisions Issued for Human Drug Submissions
Speaker: Serena Siqueira, Director of Health Canada's Food and Drugs Act Liaison Office (FDALO)
September 2014 eCTD Symposium

Presentation #1
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July 2014 Submission of Risk Management Plans and Follow-up Commitments

Draft Guidance document: Submission of Risk Management Plans and Follow-up Commitments

Speaker: Rania Mouchantaf, PhD, A/Manager, Marketed Pharmaceuticals and Medical Devices

June 2014 Education Day

Presentation #1
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Presentation #9
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April 2014 Rx to OTC Switch Guidance Qs and As.

Presentation #1

Speaker: Kyra Paterson Senior Policy Analyst with the Natural Health Products Directorate at Health Canada
February 2014 Rx to OTC Switch Guidance

Presentation #1

Speaker: Kyra Paterson Senior Policy Analyst with the Natural Health Products Directorate at Health Canada
October 2013 Regulatory Intelligence: Staying Current in an Increasingly Regulated Global Environment

Regulatory Intelligence: Staying Current in an Increasingly Regulated Global Environment

Speaker: Linda Bowen, M.S, RAC (US, EU, CAN), FRAPS
September 2013 ISO 13485 - Implementation, Registration and Beyond

ISO 13485 - Implementation, Registration and Beyond

Speaker: Nancy Ruth, Director, Medical Devices Strategic Regulatory and Safety Life Sciences

Archived Presentations

DATE OF MEETING TITLE AND LINK TO FILE / DOWNLOAD
July 2013 Canadian Regulatory Modernization:
Natural Health Products
(PDF 4.1MB)

Speaker: Krista Coventry, M.SC. Director, Nutrition and Nutraceutical Research, Nutrasource Diagnostics Inc.

June 2013 Education Day

Canadian Regulatory Framework for Active Pharmaceutical Ingredients (APIs) (PPT 664K)

Good Manufacturing Practices (GMP) for Canadian Importer, Distributors (PPT 1.5MB)

NHP Licensing Timelines (PPT 1.7MB)

Transition Period For Natural Health Products (PPT 610K)

Yearly Biologic Product Report (YBPR) Template (PPT 299K)

Intersection of Regulatory and IP Issues (PPT 1.3MB)

Update on the Adoption & Implementation of ICH E2C (R2): Periodic Benefit Risk Evaluation (PBRER) Reporting in Canada (PPT 1.2MB)

H.Eid CAPRA Presentation (PPT 557K)

Clinical Trials Database and Other Information for Sponsors (PPT 946K)

May 2013 Canada Vigilance Database Project and eReporting (PDF 336K)

Speaker: Heather Sutcliffe Director, Marketed Health Products Safety and Effectiveness Information Bureau

Feb 2013 Proposal to Change the Regulatory Process Used to Assign Prescription Drug Status (Repeal of Schedule F) (PDF 209K)

Speakers: Marcin Boruk (Montreal), David Lee (Toronto)

Nov 15, 2012 From Market Authorization to Market Access: Bridging the clinical evidence gap (PPSX 76.3MB)

Speaker: W. Neil Palmer, President and Principal Consultant, PDCI Market Access Inc.

Oct 15-16, 2012 Symposium: Current Perspectives in Regulatory Toxicology and Safety

ICH Overview, Robin Walker (PPSX 221K)

2-Genotoxic Impurities, Reena Sandhu (PDF 1.1MB)

Metabolism Drug, Drug Interactions, Leanne Bedard (PDF 524K)

Nonclinical Biomarkers Translation to the Clinic, MalleJurima Romet (PDF 467K)

Biomarkers and Surrogate Endpoints, Agnes Klein (PDF 594K)

Non-Clinical Data Requirement, Leo Bouthillier (PDF 246K)

Biologics vs TPD Toxicology Requirements, Jon Daniels (PDF 160K)

Nonclinical Safety Biotechnology, Jian Wang (PDF 1.1MB)

How To Turn a 505(b)(2) Into An NDS/SNDS, Mary Speagle (PDF 168K)

Cardiac Safety, Colette Strnadova (PDF 639K)

Hepatotoxicity, Brian Foster (PDF 381K)

Pharmacovigilance RMPs, Rania Mouchantaf (PDF 532K)

Toxicology Future Trends, Brian Foster (PDF 680K)

Oct 3, 2012 Addressing GMP and quality challenges during Module 1 preparation (PPSX 29MB)

Speaker: Lydia Sheen, Director, Special Projects-Pharmaceutical Quality, OPTUMInsightTM

Mar 15, 2012 Evidence, Business Practices and Compliance: Understanding Pharmaceutical Industry Self-Regulation (PPSX 61MB)

Speaker: Chrisoula Nikidis, Executive Director, Ethics and Compliance, Rx&D

Jan 26, 2012 Overview of the draft revised Health Canada Guidance for Clinical Trial Sponsors - Clinical Trial Applications (PPS 19MB)

Speaker: Dr. Léo Bouthillier, Ph.D., Manager, Clinical Trials Group II (Montreal)

Nov 24, 2011 Risk Management Plans - A Health Canada Update (PPS 81MB)

Speaker: Rania Mouchantaf, PhD, Senior Evaluator, Marketed Pharmaceuticals and Medical Devices Bureau

Oct 2011 Regulatory Modernization Workshop

Regulatory Modernization Overview (PDF 250K)

Pre-submission meetings and market authorizations including Drugs for Rare Diseases (PDF 240K)

EU Orphan Drug Procedure and Experience (PDF 61K)

Pre-submission Meetings and Market Authorizations Including Drugs for Rare Diseases (PDF 82K)

Market Authorization Issuance and Amendments (PDF 1MB)

Market Authorization, Issuance and Amendments (PDF 240k)

Legislative and Regulatory Modernization Framework for Therapeutic Products (PDF 111K)

Sept 9, 2011 Compliance under CEPA - An Update on the New Substances Notification Regulations (PPSX 52MB)

Speaker: Michele Richardson BSc, MBA, Director, Regulatory Affairs, Environmental, OptumInsight

May 2011 Education Day

Post-NOC Changes Chemistry & Manufacturing (Pharmaceuticals)
Past - Present - Future
(PPT 2.3MB)

Food and Drugs Act Liaison Office (FDALO). A resource for improving relations between stakeholders and Health Canada (PPT 754K)

Natural Health Products Directorate Initiatives & Updates (PPT 950K)

Health Canada's Cost Recovery Initiative - An Overview (PPT 800K)

Update on e-Submissions at Health Canada (PPT 1.1MB)

Lifecycle Management (PDF 1MB)

International Cooperation Among Regulators (PDF 803MB)

Jan 2011 Data Protection in Canada: Strategic Considerations for Protecting Exclusivity of Innovative Drugs (PDF 213K)
Dec 2010 The Year 2020. What Will Regulatory Affairs Look Like in Canada? (PDF 258K)
October 2010 Self-Relgulation in Canada: Now and into the Future (PDF 684K)
August 2010 Post-Notice of Compliance (NOC) Changes (PDF 1.4MB)
March 2010 The Challenge of Change: Working with the Post-NOC Guidances

Joyce Pon - Post-NOC Changes (PDF 378K)

Dean Callaghan - Industry Experience with Post-NOC Quality (PDF 498K)

Randy Duhaime - Post-NOC Changes Quality Pharmaceuticals (PDF 208K)

Daniela Decina - Industry Experience Post-NOC Quality Biologics (PDF 63K)

Hugo Hamel - Post-NOC Quality Changes for Biologics (PDF 283K)

Anne Tomalin - Sponsor Perspective Post NOC Safety and Efficacy (PDF 442K)

Lisa Kelly - Post-NOC S&E (PDF 222K)

Marcin Boruk - NOC with conditions (PDF 223K)

Vianney Caron - Update on e-Submission (PDF 365K)

Pastorekova Irena - Update on e-Submission (PDF 281K)

June 2009 Education Day 2009

World Wide Clinical Trials (PPT 531K)

RMP Slides (PPT 992K)

Product Licensing (PPT 1.8MB)

Patent Slides (PPT 519K)

GMP Inspection Slides (PPT 880K)

BGTD Presentation (PPT 801K)

Updates From OCT Clourenco (PPT 648K)

April 2009 Infectious Diseases - Laying out the Therapeutic Landscape

Sepsis, John Marshall (PDF 2MB)

Prions, Neil Cashman (PDF 2.5MB)

Vaccines Industry Case Study, Irene Clement (PDF 464K)

HIV Vaccine, Frank Plummer (PDF 2.5MB)

Local Global Response to HIV AIDS, Steven Sternthal (PDF 820K)

Antibiotics, George Zhanel (PDF 1.7MB)

Infectious Diseases, Barry Hafkin (PDF 72K)

Review Approval of New Drugs for Infectious Diseases, Vinay Thatte (PDF 1MB)

Lipodystrophy, Gary Ruben (PDF 1.7MB)

Sanofi-Pasteur, Robert Van Exan (PDF 4.2MB)

March 2009 Dinner Meeting Presentation
Review of Regulations Specific to Radiopharmaceuticals and Biologics
(PDF 174K)
Jan 2009 Modernizing the Food and Drugs Act to Accommodate a Product Lifecycle Approach
(PDF 990K)
Oct 2008 Symposium: Streamlining our Regulatory Process - Your Turn to Speak

PLF Legal Perspective - Adrienne Blanchard
(PDF 168K)

PLF Industry Perspective - Anna Tomalin
(PDF 452K)

PLF Rx&D Perspective - Sheila Garven
(PDF 380K)

PLF Rx&D Perspective - Sandra Wainwright
(PDF 120K)

PLF Patient Perspective - Durhane Wong-Rieger
(PDF 120K)

PLF BIOTECanada Perspective - Phil Schwab
(PDF 204K)

Post-DIN Changes - Natasha Kuran
(PDF 444K)

You asked for advice - Agnes Klein
(PDF 360K)

Draft Quality Guidance CTAs - Burt James
(PDF 352K)

Challenges with CTAs HC Perspective - Martin Bernard
(PDF 1.4MB)

Challenges with CTAs Industry Perspective - Y Meletopoulos and L Chartrand
(PDF 156K)

BGTD Submission Review Challenges - Nancy Green
(PDF 216K)

NHPD Submission Review Challenges
(PDF 524K)

TPD Submission Review Challenges - Leo Bouthillier
(PDF 212K)

Industry Submission Review Challenges - Anne Tomalin
(PDF 428K)

Sept 2008 Dinner Meeting

Overview of the Federal Legislative and Regulatory Processe (PDF 288K)
Brigitte Zirger
Director, Bureau of Policy, Science and International Programs
Therapeutic Products Directorate

June 2008 Education Day 2008

Changes To Authorized Division - 1 Only Drugs (PPT 518K)

Natural Health Product Regulation in Canada (PPT 883K)

On Site Evaluations (PPT 413K)

Subsequent Entry Biologics (PPT 448K)

Update on Electronic Submissions (PPT 1.34MB)

May/June 2008 Progressive Licensing - Amendments to the Food and Drugs Act
Natalie Bellefeuille, Senior Legal Analyst, Progressive Licensing
Project, Health Canada
Nov 2007 Symposium: From Product Monograph to Promotion
and Other Emerging Initiatives
  Tara Bower - Introduction to the New PM
(PDF 240K)
  Bruce Boulton and Tara Bower - Product Monograph
(PDF 447K)
  Ann Sztuke-Fournier, MHPD Rolein Regulatory Oversight of Health Product Advertising
(PDF 188K)
  Ray Chepesiuk - PAAB Perspectives
(PDF 2.35MB)
  Andrew Brest - Advertising Agency Perspectives
(PDF 166K)
  Heather VanDusen - Registration and Disclosure of Clinical Trial Information
(PDF 215K)
  Anne Bowes - Changes to PMNOC Regulations
(PDF 486K)
  Gunars A Gaikis - Changes to PMNOC Regulations - Industry Perspective
(PDF 194K)
  Alan Viau Risk Management of Quality Submissions
(PDF 243K)
  Arvin Naperstkow - QOS Issues Update
(PDF 233K)
  Nancy Green - YBPR Update
(PDF 232K)
  Marilyn Schwartz - LASA Guidance Update
(PDF 171K)
  Lili Stiver - LASA Drug Names and Name Safety Research
(PDF 200K)
Aug 2007 CAPRA Best Practices for Pre-Submission Meetings
Veronica Yip
May 2007 CAPRA Education Day 2007
Better Submissions - Faster Approvals - Diligent Compliance
  CAPRA Education Day 2007 Attendees list
(PDF 56K)
  Common Deficiencies in NDSs, SNDSs and CTAs at BGTD.ppt
Georgette Roy (PDF 304K)
  Minutes break out session Deficiencies in NDSs, SNDSs and CTAs at BGTD
Georgette Roy, Jian Wang, KwokHim Yeung and Christopher Antonio
(PDF 140K)
  Deficiencies in (A)NDSs and S(A)NDSs at TPD
Caroline Vanneste and LÈo Bouthillier (PDF 250K)
  Minutes break out session Deficiencies in (A)NDSs and S(A)NDSs at TPD.pdf
Caroline Vanneste and LÈo Bouthillier (PDF 110K)
  Clinical Trial Applications - Understanding and Improving the Current Process
Yadvinder Bhuller (PDF 710K)
  Minutes break out session Clinical Trial Applications - Understanding and Improving the Current Process
Yadvinder Bhuller (PDF 30K)
  Reporting Adverse Reactions to the Marketed Health Products Directorate
Heather Sutcliffe (PDF 330K)
  An Overview of the New Substances Notification Regulations of CEPA 1999
Jessica Maeck (PDF 130MB)
  The Law of Data Protection in Canada: Impact on the Pharmaceutical Industry
Jason Markwell and Kristin Wall (PDF 7.28MB)
  Nonprescription TPD Drug Monographs: Revisions and Updates
Natasha Kuran (PDF 208K)
April 2007 To File or Not to File? Post-Approval Changes & Progressive Licensing
  Post-NOC Overview
Joyce Pon
(PDF 1MB)
  Safety and Efficacy
Lisa Kelly
(PDF 236K)
  Quality Human Use
Gary Condran
(PDF 1.3MB)
  Quality Veterinary Use
Kian Mazaheri
(PDF 213K)
  Quality Biologics
Hugo Hamel
(PDF 285K)
  Quality Radiopharmaceuticals
Rezaul Mannan
(PDF 247K)
  Quality by Design
Krishnan Tirunellai
(PDF 1.07MB)
  Industry Perspective
Daniela Decina
(PDF 101K)
  PLF
David Lee
(PDF 457K)
  Modernization
Mike Ward
(PDF 58K)
  Progressive Licensing Framework Workshop Report
Jacquie Dale, President-CEO One World Inc.
(PDF 272K)
Nov 2006 Nov 2006 Symposium
Same or Similar? Considerations in Bioequivalence and Biosimilarity
  Basic Pharmacokinetics for Pharmaceutical Products
John Cobby
(PDF 360K)
  Factors Affecting Pharmacokinetic Profiles of Pharmaceuticals
Peter Mullen
(PDF 199K)
  Toxicokinetics for Pharmaceuticals and Biologics
Geoff Goodfellow
(PDF 372K)
  Pharmaceutical Development (ICH Q8)
Peter Doherty
(PDF 63K)
  New Health Canada Bioequivalence Guidances
Andrew Tam
(PDF 316K)
  Similar Biological Products and Quality Issues
Alex Kanarek
(PDF 128K)
  BGTD Perspective on Biosimilarity
Kwasi Nyarko
(PDF 333K)
  EU & US Perspectives on Biosimilarity
Linda R. Horton
(PDF 233K)
  Development Challenges for Biological Products
Karen Burke
(PDF 817K)
  Pharmacogenomics
Lois Hinman
(PDF 659K)
  Evolution of Bioequivalence Guidelines in Canada
Jake Thiesse
(PDF 487K)
  Quality Risk Management (ICH Q9)
John McCluskey
(PDF 260K)
June 2006 Good Review Practices: SOP on Drug S&E Reports
Caroline Vanneste, TPD.
(Powerpoint 261K)
June 2006 Education Day 2006

ONTARIO FORMULARY REFORM (BILL 102)
Jason C. Markwell
(Powerpoint 211K)

DIRECT TO CONSUMER ADVERTISING ñ Challenges, Risks and Pitfalls
Penny S. Bonner
(Powerpoint 307K)

Issues in the Biologic Review Process
Georgette Roy
(Powerpoint 646K)

Post-Notice of Compliance (NOC) Changes
(Powerpoint 760K)

Post-Notice of Compliance (NOC) Changes Discussion
(Powerpoint 587K)

Product Monographs in the New Format
Tara Bower
(Powerpoint 275K)

Streamlining the Review Process
Kevin Doyle
(Powerpoint 275K)

Subsequent Entry Biologics
Kwasi A. Nyarko, PhD
(Powerpoint 657K)

May 2006 Post-Notice of Compliance (NOC) Changes
Presentation to CAPRA by Health Canada
(Powerpoint 651K)
April 2006 Creating Submission Ready eCTD Documents: Best Practices
Helen Teichman, Chestnut Solutions Inc.,
Rolando S·, Image Solutions Inc.
(Powerpoint 369K)
Feb 2006 eCTD 2006: Harnessing Technology for Regulatory Advantage

Introduction to eCTD
What is eCTD  Helen Teichman
Transition to eCTD  Craig Anderson

Guidance/Implementation Plan
Update of E-Review Project  Barbara Benning and Mark Gill
Draft/Revised Guidance  Vianney Caron
Pilot Project  Michael Wood
HC's Interim Tool  (demonstration) Mei Ke

Experience with eCTD
eCTD Process  Sheila Hills and Leane Malone

Panel Discussion A - Health Canada
Vianney Caron and Sheila Hills
Lili Hajiesmaili and Mei Ke

Panel Discussion B - Industry
Joe Zoric
Queenia Lee
Helen Teichman
Jean Pierre Fl¸ckiger
Cindy Gratto

Global Context and Next Steps
International Context - EU  Claire Edwards
International Context - US  Sean Healey
ICH M2 Update: Version 3.3  Louis Boulay
Next Steps: Future for e-Review in Canadian Regulatory System  Pierre Charest

Feb 2006 Semir Omar, Ph.D., CBA, Natural Health Products Directorate, Health Canada
Regulations of Natural Health Products in Canada
(Powerpoint 6.83MB)
Feb 2006 Semir Omar, Ph.D., CBA, Natural Health Products Directorate, Health Canada
Regulations of Natural Health Products in Canada
(Powerpoint 6.83MB)
Nov 2005 Janet Brunette, Health Canada
Enhanced Review Capacity Initiative
(Powerpoint 359K)
Sept 2005 Tonino Antonetti, M.Sc., Drug Specialist, HPFBI - Canada
Complying with Health Canadaís Guidelines for Temperature Control of Drug Products During Storage and Transportation
(Powerpoint 826K)
June 2005 CAPRA Education Day

Health Protection Legislation Renewal
Bruno Rodrigue (Powerpoint 238K)

Advertising Standards Canada
Dora Gelntis (Powerpoint 678K)

Pharmacovigilance, The New Angst Over Drug Safety
Dr. Curt Appel (Powerpoint 416K)

Quality Guidance Documents Update 2005
Gary Condran (Powerpoint 127K)

Rx-To-OTC Switches
Gerry Wright (Powerpoint 1.3MB)

Proposed Amendments to the PM(NOC) Regulations and the Food and Drug Regulations
Jason Markwell (Powerpoint 321K)

eCTD Regional Submission Assembly & Management (RSAM) Initiative @ Merck Frosst
Jean Pierre Fl¸ckiger, Ph.D (Powerpoint 89K)

Health Canada Update on the e-review project
Louis Boulay (Powerpoint 356K)

Start-up Aspects of eCTD
Maria Boulanger (Powerpoint 1.1MB)

Quality Overall Summary - Chemical Entities Mock-Up ("QOS-CE MOCK-UP")
Bureau of Pharmaceutical Sciences (PDF 528K)

Electronic Regulatory Submission (ERS) Project Experience
Queenia Lee (Powerpoint 3.3MB)

PAAB Update
Ray Chepesiuk (Powerpoint 171K)

eCTD Submission Management
Ted Hanebach (Powerpoint 1MB)

June 2005 Siddika Mithani, Therapeutic Products Directorate, Health Canada
CIOMS VI Management of Safety Information from Clinical Trials
(Powerpoint 61K)
May 2005 Vicky Hogan, Marketed Health Products Directorate, Health Canada
Strengthening ëReal Worldí Drug Safety and Effectiveness
in Canada: Challenges and Priorities

(Powerpoint 720K)
April 2005 DIABETES: Current Practice, Future Trends
Presentations are available for the following speakers:

Current Profile of the Disease

Insulin: Past, Present and Future
Dr. Mohammed Eid (PDF 1.34MB)

Cardiovascular Complications and Current Treatments
Dr. Alice Cheng (PDF 391K)

Managing the Challenges of Diabetes
Debbie Hollahan (PDF 1.52MB)

Current Research

Etiology and Immunology of Type 1 Diabetes
Dr. Diane Wherrett (PDF 575K)

Islet Transplantation
Dr. Minna Woo (PDF 672K)

Clinical Trial Design

The Impact of Guidelines and Recently Completed Studies on Clinical Design (Oral Agents)
Dr. Jim Gallivan (PDF 253K)

The Impact of Guidelines and Recently Completed Studies on Clinical Design (Insulin Studies)
Dr. Norm Viner (PDF 91K)

The Design and Challenges of Phase II and III Registration Studies
Dr. Paul Aftring (PDF 3.3MB)

Review and Approval of New Drugs for Diabetes in Today's Climate
Dr. Jim Sutherland (PDF 488K)

Marketed Health Products Directorate on Market Safety Evaluations
Dr. Maria Valois (PDF 278K)

April 2005 Nancy Shadeed, Head, Regulatory and Scientific Section, Health Canada
Medical Device Licence Applications, Workload and Other Challenges
(Powerpoint 576K)
March 2005 Dr. Peter R. Ganz, Director, Biologics and Radiopharmaceuticals
Evaluation Centre, Health Canada.
Evolving Regulatory Models: Biologics
(Powerpoint 22K)
Feb 2005 Laura Freeman, Office of Business Transformation,
Therapeutic Products Directorate, Health Canada
Dispute Resolution in the Drug Submission Process:
Proposed Changes to TPD and BGTD Appeal Procedures

(Powerpoint 628K)
Jan 2005 Jean Saint-Pierre, Coordinator, Good Clinical Practices Unit
Inspection of Clinical Trials in Canada.
Results of inspections conducted in 2003/2004

(Powerpoint 157K)
Nov 2004 Laura Freeman for Tara Bower, Project Manager,
SBD Therapeutic Products Directorate
Summary Basis of Decision (SBD): On the Road to Implementation
(Powerpoint 614K)
Oct/Nov 2004 Marilyn Schwartz, Therapeutic Products Directorate.
The Drug Performance Report: The Good, The Bad and The Ugly
(Powerpoint 2MB)
June/July 2004 Dr. Paul Roufail, Bureau of Metabolism, Oncology and Reproductive Sciences Role of BMORS as a "Clinical Review Bureau" within TPD
(Powerpoint 413K)
June 1-2, 2004 From CTD Experience to eCTD Implementation: The Strategy in Canada

CTD Implementation
Mike Ward - CTD Implementation, Where are we now
Ellen Birnbaum and Julie Clare - Finalizing Guidance, Preparation of NDSs in the CTD Format
Arvin Naperstkow - TPD Quality Guidance and New Templates
Hing Chong - BGTD Quality Guidances
Susan Stojdl - Update on Comparative Bioavailability

CTD Experience - Health Canada Panel
Ellen Birnbaum - HC CTD Experience
Julie Clare - HC CTD Experience
Arvin Naperstkow - HC CTD Experience

CTD Experience - Industry Panel
Marie Beaton - Industry CTD Experience
Bonnie Meloche - Industry CTD Experience
Jason Soler - Industry CTD Experience
Bonnie Southorn - Industry CTD Experience

eCTD Implementation
Filippo Gagliardi - e-Review Project
Jennifer Kutlesa - eCTD Implementation Outline
Louis Boulay - Overview of eCTD Guidance, Transition Plan, Demonstration
Lili Hajiesmaili - Readiness to Accept eCTD Submissions
Andrew Marr - eCTD in Other Jurisdictions, European and ICH Update
Joseph Cipollina - Global Documentation and Dossier Management

eCTD Experience - Health Canada Panel
Vianney Caron - HC eCTD experience
Rachel Danserau - HC eCTD experience
Edward Slot - HC eCTD experience

eCTD Experience - Industry Panel
Marie Beaton - Industry eCTD Experience
Bonnie Southorn - Industry eCTD Experience
Manon St-Cyr - Industry eCTD Experience
Joe Zoric - Industry eCTD Experience

May 2004 Kevin Doyle and Sheila Hills, Office of Business Transformation, Therapeutic Products Directorate (TPD) Business Transformation within the TPD-A Progress Report
(Powerpoint 246K)
Mar 2004 Dr. Agnes Klein, Biologics and Genetic Therapies Directorate (BGTD)
Benefits and Risks of Biologicals
(Powerpoint 117K)
Mar 2004 Dr. Anthony Ridgway, Biologics and Genetic Therapies Directorate (BGTD)
The ICH Q5E Document
(Powerpoint 163K)
Feb 2004 The Road Beyond NOC (We've got our NOC!! - what's next?)

Betsy Miller - Planning and Implementing a Reimbursement Submission Strategy
(PDF 65K)

Barb Shea - Update on the Common Drug Review (CDR)
(PDF 1470K)

Neil Palmer - Pricing Strategies and Impact of Cross-Border Drug Sales
(PDF 1000K)

David Cowie - Update on the Patented Medicines (Notice of Compliance) Regulations and Patent Register Procedures
(PDF 93K)

Ray Chepesiuk - Pharmaceutical Advertising Advisory Board (PAAB) Code Review
(PDF 52K)

Elizabeth Smith-Kawasaki - Direct to Consumer Advertising
(PDF 74K)

Niten Barua - Coordination of Pre-launch Activities between Regulatory and Key Functional Areas
(PDF 108K)

Carol Repchinsky - How to get your products into PRINT and DIGITAL CPS
(PDF 313K)

Lisa Katz-Jones and Victoria Prince - Privacy Act (PIPEDA)-an Overview
(PDF 328K)

Curt Appel - Pharmacovigilance The Way Ahead - Swimming Upstream in Muddy Waters
(PDF 236K)

Micheline Ho - Update on Regulations, Guidelines and Templates
(PDF 171K)

Carlo Di Fonzo - Optimizing the Product Monograph for all Customers
(PDF 138K)

Stephanie Priest - Filing Post-NOC Submissions to the BGTD
(PDF 107K)

Ellen Birnbaum - Supplementary Filings to TPD, What you need to know
(PDF 79K)

Jan/Feb 2004 Sultan Ghani, Therapeutic Products Directorate (TPD).
(Powerpoint 211K)
Nov/Dec 2003 Stephanie Priest, Biologics and Genetic Therapies Directorate (BGTD)
(PDF 190K)

Sept/Oct 2003

Ray Chepesiuk, Pharmaceutical Advertising Advisory Board (PAAB)
(PDF 189K)

Linda Nagel, Advertising Standards Canada (ASC)
(PDF 667K)

May 2003 Dr. Supriya Sharma and Bill Leslie, Marketed Health Products Directorate
(PDF 650K)
April 2003

Getting Ready for eCTD

Bob Kapitany - eCTD is NOT just an Electronic CTD
(PDF 193K)

Joseph Montgomery - ICH M2 Status Update
(PDF 71K)

Stan Van Belkum - eCTD Implementation: EU and EMEA
(PDF 507K)

Joseph Montgomery - eCTD Implementation: USA
(PDF 369K)

Harv Martens - eCTD Implementation: Japan
(PDF 753K)

Sheila Hills - eCTD Implementation: Canada
(PDF 111K)

Tomas Hansson - eCTD Specification: Highlights and Impacts
(PDF 338K)

Michael Brennan - eCTD Case Study 1: GSK
(PDF 6000K)

Stan Van Belkum