DIA’s Annual Canadian Meeting: New Reality/New Frontiers

Tutorials: October 28, 2013 | Meeting: October 29-30, 2013 | Ottawa, Ontario, Canada

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GO DIA’s Annual Canadian Meeting

Collaborate with key stakeholders: boost awareness and deliver value to today’s patient reality driving change in drug development and regulations.

At this Annual Meeting, stakeholders from industry, regulatory agencies, academic researchers, patient and patient advocacy groups will have the opportunity to work together to recognize the challenges faced by the industry and regulators in drug development, market access, and regulations in Canada.

View Program Agenda
Program Agenda

Register Online

Insider UpdateInsider Update

This edition of Insider Update provides insights from key industry thought leaders about how New Frontiers are driving pipelines forward taking into consideration the ever changing regulatory environment.

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GO Registration Fees

Group Discounts
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.

Submit a registration form by fax to +1.215.442.6199.

Registration Questions? CustomerService@DIAHome.org or at +1.888.257.6457.

Participants with Disabilities
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

GO Tutorials

The Emerging PV Landscape in Canada

Chanez Kebache
Manager, Pharmacovigilance Mallinckrodt Pharmaceuticals.

This tutorial will focus on four emerging areas of change in pharmacovigilance (PV) and present them within a Canadian context. The first area deals with the new good pharmacovigilance practice (GVP) Inspection guidelines and policy that have been released by Health Canada and become effective September, 2013. Areas of change from previous inspection model will be highlighted.

The second area in this tutorial will focus on the recently announced acceptability of Periodic Benefit Risk Evaluation Reports (PBRERs) to meet the requirements for Canadian Summary reports in Canada. Focus will be on how these reports differ from PSURs and how to begin to develop these new format reports for Canadian submission.

The third emerging area of change that will be reviewed is the development of the PV Master File, a new concept recently introduced by Europe, and the associated PV Quality System. We will review how to set up a PV Master File in Canadian context and how to set up a robust PV Quality System. Discussion will focus on implementing the Master file concept and maintaining it over time. We will discuss the benefits of moving in this direction for Canada only and within the context of a global PV environment.

The fourth area will overview the Risk Management Plans (RMPs) in Canada, their current status and general considerations when submitting them, background on Drug Utilization Research and describe Health Canada expectations when designing them, and applied overview of some common Health Canada Risk Management Plan review comments will be provided.   

Rita Cassola, B.Pharm. Hons. 
Senior Director, Pharmacovigilance 

Blair MacKenzie
Senior Compliance Officer
Compliance and Enforcement Inspectorate Program Prairie Region – Alberta
Health Canada

Rania Mouchantaf 
Scientific Evaluator 
Health Canada

Target Audience:
Pharmacovigilance, Medical Information and Regulatory staff interested in meeting the new PV challenges developing globally. QA, Medical and Clinical Research staff will also find this of interest as there are areas that touch on these discipline areas. Those in Project Management, General Management and Marketing will obtain a good understanding of the ongoing changes within the PV environment and how they impact industry.

Tutorial Objectives:
At the conclusion of this tutorial, participants should be able to:

  • Explain the changes in the new GVP Inspection process and the expectations that come with these changes
  • Describe how the new Periodic Benefit Risk Evaluation Report (PBRER) will replace the PSUR (Periodic Safety Update Report) and if it meets or does not meet the Canadian requirements for an Annual Summary Report
  • Discuss the use of the Pharmacovigilance Master File and how to build a file moving forward
  • Discuss the status, design and expectations regarding Risk Management Plans in Canada

Trends in Health Canada Inspections
Rocelyn DelCarmen
Regulatory Affairs and Quality Assurance AstraZeneca, Inc.

This tutorial will focus on recent trends in Health Canada Inspections from the perspective of the Inspectorate and the Industry it regulates.
Following an overview of the Inspectorate and the Inspection strategy for drugs, medical devices and clinical trials, the Inspectorate and Industry will discuss emerging trends.

The Inspectorate will present a summary of top observations, including examples on GMP, medical devices and clinical trial inspections. Industry speakers will discuss how recent Inspection observations have changed their operational practices in Canada and globally.

Additionally, HPFBI will provide Industry with advice on areas considered “grey space”.

Julie Calendino
Senior Corporate Regulatory Compliance and Enforcement Advisor 
Medical Device Compliance
Health Canada

Linda Jack, PhD
Director, Regulatory Affairs and Quality Management Group Leader PDR
US Marketed Products 
Hoffmann-LaRoche Limited

Targeted Audience:
Professionals involved with leading and participating in Health Canada inspections, e.g. Quality Assurance, Quality Compliance, Quality Operations, Supply Management and Regulatory Affairs. Professionals with an interest in quality system frameworks for drugs and medical devices in Canada. Those in Project Management and General Management can get an understanding of the recent trends within the GMP environment and how they can impact Industry operational aspects.

Tutorial Objectives:
At the conclusion of this tutorial, participants should be able to:
  • Discuss the HPFBI’s current mandate and operations for GMP oversight in the areas of drugs and medical device manufacturing, importing and distribution
  • Describe how Industry should prepare for drug and medical device inspections by gaining knowledge of recent inspection findings and issues and how some companies have adapted operations to respond
  • Apply advice from the Inspectorate on managing topics that drug and medical device manufacturers, importers and distributors seek clarity on.

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