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DIA’s Annual Canadian Meeting: Thinking Globally, Acting Locally for The Well-Being of the Patient

Oct 28 2014 8:00AM - Oct 29 2014 5:00PM | Ottawa Marriott Hotel 100 Kent Street Ottawa, ON K1P5R7 CANADA

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Overview 

Pre-meeting Tutorials:  October 27, 2014


New communication platforms, technologies and the establishment of the “global village” have made the medicines’ life cycle rapidly evolving and increasingly global. Yet the fiduciary role of health care professionals and the life cycle management of the medicines by regulators, industry, and payers remains primarily a local responsibility. Information today is moving at the speed of light across borders, impacting each country differently due to varied regulatory and health care practices. This creates an obvious challenge for the government, industry, and health care providers in trying to find the best harmonized approaches. It represents an even greater challenge to patients and consumers in trying to make the best health care decisions. Therefore, the patient needs have to drive the improvements and changes in the regulatory environment and medicine development, commercialization and access. This requires transparent and appropriate communications so that patients and consumers can become well informed, educated, and empowered.

This year DIA will bring key thought leaders and experts from various fields to explore this challenging dilemma for the Canadian stakeholders. This meeting will address the following questions:

  • How can we remain among the top world innovators in the regulatory and health care science?
  • How can we harmonize with other regulatory jurisdictions and ensure sustainability of our regulatory and health care system?
  • How can we ensure the continuous access of quality and state-of-the art medicines and devices
  • How can we promote optimal health for Canadians?



Meeting Highlights

  • Keynote address
  • Multi-track breakout sessions
  • Pre-meeting tutorials
  • Call for abstracts
  • Networking reception
  • Tabletop exhibiting opportunities

Who Should Attend 

Professionals involved in:

  • Regulatory Affairs
  • Policy/Pharmacoeconomics
  • Clinical Development
  • Drug Safety/Pharmacovigilance
  • Patient Safety
  • Medical Communications
  • Quality Operations

Learning Objectives 

At the conclusion of this meeting, participants should be able to:

  • Describe the current and evolving regulatory environment in Canada
  • Recognize the challenges faced by various Canadian stakeholders in the development, regulation, harmonization, and the access of state-of-the-art medicines and devices within a global context
  • Discuss vendor management and the impacts of outsourcing
  • Describe the challenges around providing relevant and acceptable communications to patients, health care professionals and consumers

Special Offers 

Early Bird Registration
Industry Members save $150
Register by October 6, 2014

Group Discount Available!
Register 3 and Get the 4th Free!

Hotel & Travel 

The conference will be held at the Ottawa Marriott Hotel. 
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until Monday October 9, 2014, or until room block is filled). Please Note: In order to receive the reduced room rate, hotel reservations must be made through Travel Planners, and not directly with the hotel.  Contact information for Travel Planners is as follows: Attendees can follow this link or call +1.212.532.1660 or in the USA at 1.800.221.3531. When calling please select option 1 for “Hotel Reservations,” inform the phone agent that you are making a reservation for Event #14019. 

Standard Room Rate $153

Hotel Address: 100 Kent Street, Ottawa, Ontario K1P 5R7, Canada

PLEASE READ
Warning: Unauthorized Solicitation

The most convenient airport is Ottawa Macdonald-Cartier International Airport and attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Printable Registration Form

Registration Questions
Customer Service Department
Toll Free: 1.888.257.6457
Phone: +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

Agenda Details
Rachel Minnick, Content Lead
Phone +1.215.442.6131
Fax +1.215.442.6199
Rachel.Minnick@diahome.org

Jessica McGrory, In-company Training Manager
Phone +1.215.442.6182
Fax +1.215.442.6199
Jessica.McGrory@diahome.org

 

Event Logistics
Stephanie Ritter, Event Planner
Phone +1.215.442. 6149
Fax +1.215.442.6199
Stephanie.Ritter@diahome.org

Tabletop Exhibit Information
Jeff Korn, Exhibits Associate
Phone +1.215.442.6184
Fax +1.215.442.6199
Jeff.Korn@diahome.org

Continuing Education 

The Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .3 CEUs for each tutorial. Participants must attend the entire tutorial in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

Name Credit Type Max Credits CEU
Risk Management Plans and Drug Utilization Studies IACET 3.25 0.300
Biostatistics for Non-Statisticians IACET 3.25 0.300

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must attend the tutorial, sign in at the DIA registration desk, and complete the on line credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Wednesday, November 12, 2014.

Program Committee 

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Agenda  

Tutorials Monday, Oct 27, 2014

  • 1:30PM - 5:00PM

    Risk Management Plans and Drug Utilization Studies in Canada

    Regulators around the world have expanded their investment and policy frameworks in the development of tools to assess both pre- and post-market safety evidence. These efforts have expanded with the implementation of a number of International Conference on Harmonisation (ICH) guidelines including ICH E2E Guideline. The tutorial is intended to provide participants with an overview of the 2014 Health Canada Draft Guidance Document entitled: “Risk Management Plans and Follow-up Commitments.” Additionally the assessment of benefit-risk of medicines needs careful consideration concerning their patterns of utilization; a component that is increasingly becoming an integral component of risk management planning. The course will therefore provide a training on Drug Utilization Studies (DUS) in addition to a discussion of alternative options in situations where full DUS are not feasible.

  • 1:30PM - 5:00PM

    Biostatistics for Non-Statisticians

    Tutorial overview available soon.

     

Day 1 Tuesday, Oct 28, 2014

  • 8:15AM - 8:30AM

    Welcome and Opening Remarks


    Session Chair(s):

    • Co Pham
      Senior Scientific Advisor, Marketed Health Products Directorate
      Health Canada, Canada
    • Vratislav Hadrava, MD, PhD
      Vice President and Medical Director, Global Innovative Products
      Pfizer Canada, Inc., Canada

    Welcome and Opening Remarks

    Speaker(s):

    • Assistant Deputy Minister
      Health Canada, Canada
  • 8:30AM - 10:00AM

    Plenary Session 1: Putting Patients First; What Does It Look Like in 2014 to be a Patient-Centric Organization - Part 1


    Session Chair(s):

    • Co Pham
      Senior Scientific Advisor, Marketed Health Products Directorate
      Health Canada, Canada

    Plenary Session 1: Putting Patients First; What Does It Look Like in 2014 to be a Patient-Centric Organization - Part 1

  • 10:00AM - 10:30AM

    Refreshment Break
  • 10:30AM - 12:00PM

    Plenary Session 2: Putting Patients First; What Does It Look Like in 2014 to be a Patient-Centric Organization - Part 2


    Session Chair(s):

    • Marie-Ange Noue, PhD
      Proj. Manager, Drug Safety/Medical Information, Deputy Local Drug Safety Officer
      EMD Serono, Canada

    Plenary Session 2: Putting Patients First; What Does It Look Like in 2014 to be a Patient-Centric Organization - Part 2

    Speaker(s):

    • Bernard Keating
      Prof, Dir, Applied Ethics Programs, Faculty of Theology and Religious Studies
      Laval University, Canada
    • Durhane Wong-Rieger, PhD, MA
      President and Chief Executive Officer
      Canadian Organization For Rare Disorders (CORD), Canada
  • 12:00PM - 1:30PM

    Lunch
  • 1:30PM - 3:00PM

    Session 3 - Track A: Communications with Regulators and Among Industry


    Session Chair(s):

    • Vratislav Hadrava, MD, PhD
      Vice President and Medical Director, Global Innovative Products
      Pfizer Canada, Inc., Canada

    Session 3 - Track A: Communications with Regulators and Among Industry

  • 1:30PM - 3:00PM

    Session 3 - Track B: Vendor Management


    Session Chair(s):

    • Carolyne Desrosiers
      Manager, Regulatory Projects
      Lundbeck Canada Inc, Canada

    Suppliers and 3rd parties play a key role in today’s pharmaceutical industry. Outsourced activities such as clinical trial management, manufacturing, analysis, warehousing, and distribution are commonplace. Vendor management is an important discipline that enables organizations to control costs, drive service excellence and mitigate risks to gain increased value from their vendors throughout a project’s life cycle.

    Speaker(s):

    • From the Vertical to Horizontal Integration: Benefits and Pitfalls of Outsourcing Manufacturing
      Mohammed Razdar Khan
      Principal
      Synergex Consulting, Canada
    • Vendor Oversight for Small and Medium Sized Sponsors: Methods to Achieve Operational, Compliance, and Business Objectives
      Peter Motteram, MSc
      Director
      P.A.S.M. Limited, United Kingdom
  • 1:30PM - 3:00PM

    Session 3 - Track C: Patient Access


    Session Chair(s):

    • Marie-Ange Noue, PhD
      Proj. Manager, Drug Safety/Medical Information, Deputy Local Drug Safety Officer
      EMD Serono, Canada

    Session 3 - Track C: Patient Access

    Speaker(s):

    • Lindy Forte
      Principal Consultant
      Patient Access Solutions, Canada
    • Brent Fraser
      Director, Drug Program Services, OPDP
      Ontario Ministry of Health, Canada
  • 3:00PM - 3:30PM

    Refreshment Break
  • 3:30PM - 5:00PM

    Session 4 - Track A: Health Canada Regulations – The Nuts and Bolts


    Session Chair(s):

    • Rocelyn DelCarmen
      Director, Regulatory Affairs and Quality Assurance
      AstraZeneca, Inc., Canada

    Harmonization efforts have streamlined many regulatory requirements across the globe. There remains a few areas in the regulatory regime where Canadian requirements differ from other regions. During this session Health Canada and Industry speakers will review these areas of differentiation with a discussion of why the regime exists, and how stakeholders “act locally” to address it.

    Speaker(s):

    • Bioequivalence – Health Canada’s Requirements
      Representative Invited
      Bureau of Pharmaceutical Sciences
      Health Canada, Canada
    • Impact of Canadian Specific Requirements for CRFs
      Samar Darwish, MSc
      Director, Regulatory Affairs and Drug Safety
      Boehringer Ingelheim Canada, Canada
    • Product Testing Requirement for Importing Drugs from the Non-MRA Countries
      David Lessard
      Pfizer Canada Inc., Canada
  • 3:30PM - 5:00PM

    Session 4 - Track B: Inspectorate Town Hall – GVP Inspections


    Session Chair(s):

    • Chanez-Narimene Kebache
      Manager, Pharmacovigilance
      Mallinckrodt Pharmaceutical, Canada

    As part of Health Canada’s (HC) mandate to maximize the safety, quality and efficacy of health products, the Health Product and Food Branch (HPFB) Inspectorate posted in 2013 on the HC’s website the new guidance document entitled “Good Pharmacovigilance Practices (GVP) Guidelines” (GUI-0102) and the revision to the “Risk Classification of Good Pharmacovigilance Practices (GVP) Observations” (GUI-0063).

    The industry’s perspective on the impact of the implementation of GUI-0102 and GUI-0063 on the conduct of GVP inspections will be discussed with an opportunity for interactive participation by the audience. A HC’s Inspectorate representative will provide an overview of the main deficiencies observed during GVP inspections that have been conducted since the implementation of GUI-0102.

    Speaker(s):

    • Sophie Lafrance
      Compliance Officer, HPFB Inspectorate
      Health Canada, Canada
    • Agnes Jankowicz
      Executive Director, PV
      Certus PV Services Inc., Canada
    • Robert Milne
      Manager Drug Safety / Medical Information
      EMD Serono, Canada
  • 3:30PM - 5:00PM

    Session 4 - Track C: Communication to Patients and Public/Consumer


    Session Chair(s):

    • Janice Lobo-Dale
      Regulatory Analyst, Biologics and Genetic Therapies Directorate
      Health Canada, Canada

    Session 4 - Track C: Communication to Patients and Public/Consumer

Day 2 Wednesday, Oct 29, 2014

  • 8:30AM - 10:00AM

    Session 5 - Track A: Transforming Drug Safety and Surveillance


    Session Chair(s):

    • Rocelyn DelCarmen
      Director, Regulatory Affairs and Quality Assurance
      AstraZeneca, Inc., Canada

    In 2014, the Government of Canada introduced Bill C17 and many provisions included in the bill will assist in transforming drug safety and surveillance. During this session Health Canada and Industry will provide insight into how drug safety and surveillance will change in the future as new laws and systems are put into place in Canada.

    Speaker(s):

    • Continuous Improvement Efforts by Health Canada to Enhance the Human Cells, Tissues and Organs Surveillance System in Canada
      Vicky Ann Hogan, PhD, MSc
      Manager, Blood Tissues and Organs Scientific Section
      Health Canada, Canada
    • Implementing C17, Update and Next Steps-Health Canada Perspective
      David K. Lee
      Director, Office of Legislative and Regulatory Modernization
      Health Canada, Canada
    • Implementing C17 Opportunities and Challenges - Industry Perspective
      Keith McIntosh
      Senior Director, Scientific & Regulatory Affairs
      Rx & D, Canada
  • 8:30AM - 10:00AM

    Session 5 - Track B: New Technologies and Evolving Science as a Challenge to Regulatory Framework


    Session Chair(s):

    • Matthew Ryan
      Senior Advisor, Director General's Office, Therapeutic Products's Directorate
      Health Canada, Canada

    Session 5 - Track B: New Technologies and Evolving Science as a Challenge to Regulatory Framework

    Speaker(s):

    • Agnes V. Klein, DrPH, MD
      Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products
      Health Canada, Canada
  • 8:30AM - 10:00AM

    Session 5 - Track C: Health Technology Assessments


    Session Chair(s):

    • Karen Feltmate
      President
      Redstone Health Group, Inc., Canada

    While regulators have developed avenues to provide patients early access to new therapies ie priority review, NoC with conditions, it is not as obvious what the post NoC market Access Stakeholders ie Drug Programs, Public and Private have/are doing. This session will look at various Market Access Stakeholders, their role in the Market Access process, their responsibility to patients within their jurisdiction and how their HTA review aligns to their patient responsibility.

  • 10:00AM - 10:30AM

    Refreshment Break
  • 10:30AM - 12:00PM

    Session 6 - Track A: Subsequent Entry Biologics/Biosimilars


    Session Chair(s):

    • Andrew Storey
      Vice President, Regulatory Affairs United States and Canada
      AbbVie, United States

    With the expiration of numerous patents for originator biologicals and the development of follow-on products, the market for biosimilars is growing at a rapid pace. These biosimilars and follow-on biologics have garnered interest for their cost-effective benefits in patient care but questions remain about many aspects of “similarity." As biosimilars become more available to patients, there are important factors for patients and health care providers that must be addressed. This session will focus on the innovations, technologies, and regulatory information surrounding biosimilars

    Topics to be covered include Canadian and US Regulatory Developments, Interchangeability, Labeling, Naming, and Extrapolation and will be reviewed from various perspectives.

    Speaker(s):

    • Agnes V. Klein, DrPH, MD
      Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products
      Health Canada, Canada
    • Keith Watson, PhD
      Director
      AbbVie Ltd, United Kingdom
  • 10:30AM - 12:00PM

    Session 6 - Track B: Biostatistics


    Session Chair(s):

    • Deirdre Cozier
      Pharmascience, Canada
    • Patrick Massad
      Chief Review Officer
      Pharmaceutical Advertising Advisory Board (PAAB), Canada
  • 10:30AM - 12:00PM

    Session 6 - Track C: Simplifying Clinical Trial Execution in Canada in the Interest of Patients


    Session Chair(s):

    • Janice Lobo-Dale
      Regulatory Analyst, Biologics and Genetic Therapies Directorate
      Health Canada, Canada

    Session 6 - Track C: Simplifying Clinical Trial Execution in Canada in the Interest of Patients

    Speaker(s):

    • Best Practices for Managing Succesful Clinical & Pharmaceutical Projects
      Zizi Imatorbhebhe, MBA, MS
      Principal
      Alliance Bio-Pharm & Health Partners, United States
    • Clinical Trials in Canada: Extraterritorial Application of US Laws and Regulations
      Jack Corman
      Managing Director
      IRB Services (a Chesapeake IRB Company), Canada
    • The Initiative to Streamline Investigator Initiated Clinical Trials: Guidelines for Managing Canadian Regulatory Expectations
      Karen Arts, BSN, MSN, RN
      Director, Business Development, High Impact Clinical Trials
      Ontario Institute For Cancer Research, Canada
  • 12:00PM - 1:30PM

    Lunch
  • 1:30PM - 3:00PM

    Plenary Session 7


    Session Chair(s):

    • Vratislav Hadrava, MD, PhD
      Vice President and Medical Director, Global Innovative Products
      Pfizer Canada, Inc., Canada
    • Co Pham
      Senior Scientific Advisor, Marketed Health Products Directorate
      Health Canada, Canada

    Plenary Session 7

    Speaker(s):

    • Cathy Evanochko
      Co-Chair, Founding Board Member
      Tuberous Sclerosis Canada Sclerose Tubereuse, Canada

Exhibits  

The Annual Canadian Meeting offers interested companies the opportunity to exhibit with a tabletop display.

Tabletop Fee: $1,500

Fee Includes:

  • One six-foot skirted table
  • One chair
  • Standard electricity

Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.

Tabletop Exhibit Dates: October 28-29, 2014

Useful Links:

  • Contact Canada
  • LORENZ Life Science Group
  • Optum

Registration Fees 

Member

Member Government
$630.00
Member Academia
$785.00
Member Standard
$1420.00
Member Standard (As of 10/07/2014)
$1570.00

Non-Member

NonMember Government
$855.00
NonMember Academia
$1010.00
NonMember Standard
$1795.00
Registration Fees for Additional Offerings
Risk Management Plans and Drug Utilization Studies - Tutorial Rate
$405.00
Biostatistics for Non-Statisticians - Tutorial Rate
$405.00
Group Discounts

Printable Registration Form

Group Discount

Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time – no exceptions.

To take advantage of this offer, please make a copy of the registration form for EACH of the four registrants and include the names of all other group registrants in the Group Discount section. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia.

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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