Canadian Pharmacovigilance and Risk Management Strategies ...

[Pages:4]Canadian Pharmacovigilance and Risk Management Strategies Conference

October 29, 2018 | Ottawa Marriott Hotel | Ottawa, ON

PROGRAM CHAIR/CO-CHAIR

Rita Cassola, RPh Executive Director PV Certus PV Services Inc., Canada

PROGRAM COMMITTEE

Marcia Bailey, RN, BSN, MHS Senior Manager, Pharmacovigilance Sierra Oncology, Canada

Colin D'Cunha, MD, MHS, FRCPC Director, Global Medical Affairs Apotex, Inc., Canada

Melissa Hunt, MSc Acting Director Health Canada

Marc Poitras, PhD, MBA Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau Health Canada

Overview

DIA's Canadian Pharmacovigilance and Risk Management Strategies Conference is the premier place to hear from expert pharmaceutical, biotechnology, and regulatory personnel. The latest updates in pharmacovigilance, risk management, and drug safety will be presented from both a global and a tailored Canadian perspective.

Highlights

? Risk management for opioids ? Cybersecurity and implications for pharmacovigilance ? Real World Evidence: Focus on Canadian Data ? Round Table discussion with the Inspector ? Global Overview ? What's New in Europe, US FDA, and Health Canada ? Canada vigilance update by Health Canada

Target Audience

Professionals Involved In: ? Clinical Safety/Pharmacovigilance ? Clinical Research ? Project Management ? Quality Assurance Control ? Regulatory Affairs

800 Enterprise Road Suite 200 Horsham, PA 19044 USA

#CanadaPV18 |

As of October 19, 2018

Schedule At-A-Glance

DAY ONE | MONDAY OCTOBER, 29

ROOM

7:00AM-5:30PM 7:00-8:00AM 8:00-8:30AM 8:30-10:00AM 10:00-10:30AM 10:30-11:30AM 11:30AM-12:30PM 12:30-1:30PM 1:30-3:00PM 3:00-3:30PM 3:30-4:30PM 4:30-5:30PM 5:30-6:30PM

Registration

Lower Level Foyer

Continental Breakfast and Networking

Lower Level Foyer

Welcome and Opening Remarks

Cartier II-III

Session 1: What's New and What's Hot: Perspective on Pharmacovigilance and Risk Management

Cartier II-III

Refreshments and Networking Break

Lower Level Foyer

Session 2: Real World Evidence for Risk Management and Support of Regulatory Decisions Cartier II-III

Session 3: Round Table with Inspector

Cartier II-III

Luncheon and Networking

Lower Level Foyer

Session 4: Risk Management for Opioids: What's New?

Cartier II-III

Refreshment and Networking Break

Lower Level Foyer

Session 5: Canada Vigilance Update

Cartier II-III

Session 6: Cybersecurity and Implications for Pharmacovigilance

Cartier II-III

CHEO-OCTC Event and Networking Reception

Lower Level Foyer

Learning Objectives

At the conclusion of this conference participants should be able to:

? Describe the current Canadian regulatory framework for pharmacovigilance ? Identify current pharmacovigilance issues facing Marketing Authorization Holders in Canada ? Describe the challenges of cybersecurity and strategies to cybersecurity implementation

Continuing Education Credit

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

As an IACET Authorized Provider, DIA offers CEUs for its programs that qualify under the ANSI/IACET Standard. DIA is authorized by IACET to offer .7 CEUs for this conference. Participants must complete the entire conference in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

If you would like to receive a statement of credit for the conference, you must sign in each day at the DIA registration desk upon arrival, and complete the online credit request process through My Transcript. 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 beginning Monday, November 12, 2018.

TO ACCESS MY TRANSCRIPT

? V isit , select "Sign in" and you will be prompted for your user ID and password

? C hoose MENU, found in the upper left corner ? U nder EVENTS select "Continuing Education" ? S elect the blue "My Transcript" button followed by "Credit

Request" to process your credit request for the course

ACCESS PRESENTATIONS

? V isit ? Select `Sign in' at the top right ? E nter your User ID and Password ? Go to `My Account' ? V iew `My Presentation'

Please Note: DIA User ID and Password are needed to access presentations. If you have forgotten your DIA User ID and Password, or this is your first time logging into the DIA website, please use our Login Reminder. *Presentations will be available for six months post conference.



Follow us @DrugInfoAssn #CanadaPV18 for real-time updates

2

DAY ONE | MONDAY, OCTOBER 29

7:00AM-5:30PM 7:00-8:00AM

Registration Continental Breakfast and Networking

8:00-8:30AM Welcome and Opening Remarks

8:30-10:00AM

Session 1: What's New and What's Hot: Perspective on Pharmacovigilance and Risk

Management

Session Chair Marc Poitras, PhD, MBA, Scientific Manager, Marketed Pharmaceuticals and Medical Devices Bureau, Health Canada

In this session, representatives from regulatory agencies and the industry will discuss the progress of the implementation of new/ongoing national, international initiatives to strengthen pharmacovigilance and risk management activities.

Optimizing Canada's Health Product Vigilance Approach: An Update Rhonda Kropp, BS, BSN, MPH, Director General, Marketed Health, Products Division, Health Canada

Overview of Benefit-Risk Assessment in Medical Product Development: Context for Patient Engagement Tarek Hammad, MD, PhD, MSc, MS, FISPE, Head of Signal Detection and Benefit-Risk Assessment, Global Drug Safety Innovation, EMD Serono, Inc., United States

10:00-10:30AM

Refreshments and Networking Break

10:30-11:30AM

Session 2: Real World Evidence for Risk Management and Support of Regulatory Decisions

Session Chair Marcia Bailey, RN, BSN, MHS, Senior Manager, Pharmacovigilance, Sierra Oncology, Canada

Although evidence from randomized controlled trials is required to establish the safety and efficacy of products for market approval, real world evidence (RWE) is essential to the risk management of marketed products. In this session, you will learn about uses of RWE and how it can help inform Canadian pharmacovigilance practices and support regulatory decisions.

Real World Evidence: Focusing on Canadian Data - The CNODES Experience Jacques Le Lorier, MD, PhD, FACP, Universite de Montreal, Canada

Accelerating Use of RWE in Regulatory Decision-Making Priscilla Velentgas, PhD, Senior Director, Science at Aetion, United States

11:30AM-12:30PM

Session 3: Round Table with Inspector

Session Chair Rita Cassola, RPh, Executive Director PV, Certus PV Services Inc., Canada

This session will provide an update on the GVP inspection program in Canada with examples of recent inspection findings.

Updates on the Good Pharmacovigilance Practices (GVP) Inspection Program Mary Morgan, Associate Director of Health Product Compliance and Risk Management Division Health Canada

12:30-1:30PM Luncheon and Networking



Follow us @DrugInfoAssn #CanadaPV18 for real-time updates

3

1:30-3:00PM

Session 4: Risk Management for Opioids: What's New?

Session Chair Rania Mouchantaf, MD, PhD, Manager, Marketed Health Product Directorate, Health Canada

This session will include a panel of speakers that will provide an overview on Health Canada's recently implemented policies to address the opioid crisis and on databases available to characterize opioid-related harms, in addition to a discussion on international experience with risk management planning for opioids.

Risk Management Plans for Opioids in Canada Andrew Slot, PhD, Manager, Health Canada

Strategies and Data Sources to Evaluate the Effectiveness of Risk Minimization Interventions for Opioids Yola Moride, PhD, FISPE, Full Professor, Faculty of Pharmacy Universit? de Montr?al, Canada

The US Approach to Opioids Risk Management: How Can Canada Use These Learnings Ravi Deshpande, PharmD, Senior Vice President, Specialty Health, McKesson Canada

3:00-3:30PM Refreshment and Networking Break

3:30-4:30PM

Session 5: Canada Vigilance Update

Session Chair Melissa Hunt, MSc, Acting Director, Health Canada

The Canada Vigilance Program is Health Canada's post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products marketed in Canada. This session will focus on what is new within the Canada Vigilance program, developments around the Canada Vigilance database, and ongoing process improvements.

Canada Vigilance Program Update Gayatri Jayaraman, PhD, Director, Marketed Health Products Safety and Effectiveness Information Bureau, Health Canada

Canada Vigilance Program Update Bill Wilson, BSc, A/Manager, Data Management and Integrity Section, Health Canada

4:30-5:30PM

Session 6: Cybersecurity and Implications for Pharmacovigilance

Session Chair Choo Por, BSc Pharm, PharmD, RPh, Manager, Global Pharmacovigilance Compliance, Apotex Inc, Canada

All one needs to know about cybersecurity will be covered briefly. A discussion on the risks and mitigation measures will be provided. Participants will be able to engage in interactive discussions.

Cybersecurity and Implications for Pharmacovigilance Tony Lee, Manager Privacy and Security, Apotex Inc, Canada

5:30PM-6:30PM

CHEO-OCTC Event and Networking Reception

DIA is pleased to partner again with the Children's Hospital of Eastern Ontario and Ottawa Children's Treatment Centre (CHEO-OCTC) to kick off the DIA Annual Canadian Meeting with a community outreach activity! Focusing on research and exceptional patient and family centered care, CHEO-OCTC seeks to continually improve the quality and the efficiency of all activities through research, benchmarking, learning, and evidence-based practices. Join us in creating trick-or-treat bags for the children of CHEO-OCTC as we network over refreshments. Attendees of the Canadian Pharmacovigilance and Risk Management Strategies Conference and DIA Annual Canadian Meeting are invited to attend.

Thank you to our media partner:



Follow us @DrugInfoAssn #CanadaPV18 for real-time updates

4

 ................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download