DIA’s Annual Canadian Meeting: Thinking Globally, Acting Locally … cycle management of the...

DIA GLOBAL CENTER21 Dupont Circle NW Suite 300

Washington DC 20036

WORLDWIDE OFFICESBasel Switzerland | Beijing China | Horsham PA USA

Mumbai India | Tokyo Japan

PROGRAM CO-CHAIRSCo PhamSenior Scientific AdvisorDirector Generalrsquos OfficeMarketed Health Products DirectorateHealth Canada

Vratislav HadravaVice President and Medical DirectorGlobal Innovative Products Pfizer Canada Inc

PROGRAM COMMITTEEChanez KebacheManager PharmacovigilanceMallinckrodt Pharmaceutical

Matthew RyanSenior AdvisorDirector Generalrsquos OfficeTherapeutic Productrsquos DirectorateHealth Canada

Marie-Ange NoueProject ManagerDrug SafetyMedical InformationEMD Serono

Deirdre Cozier RACSenior ManagerRegulatory Affairs (Canada)Pendopharm Division of Pharmascience

Carolyne DesrosiersManagerRegulatory ProjectsLundbeck Canada Inc

Karen FeltmatePresidentRedstone Health Group Inc

Andrew StoreyVice President Regulatory Affairs United States and CanadaAbbVie

Rocelyn DelCarmenDirector Regulatory Affairs and Quality AssuranceAstraZeneca Inc

Janice Lobo-DaleRegulatory Analyst Biologics and Genetic Therapies DirectorateHealth Canada

OVERVIEWNew communication platforms technologies and the establishment of the ldquoglobal villagerdquo have made the medicinesrsquo 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

LEARNING OBJECTIVESAt the conclusion of this meeting participants should be able to

bull Describe the current and evolving regulatory environment in Canada

bull Recognize the challenges faced by various Canadian stakeholdersin the development regulation harmonization and the access ofstate-of-the-art medicines and devices within a global context

bull Discuss vendor management and the impacts of outsourcing

bull Describe the challenges around providing relevant and acceptablecommunications to patients health care professionals and consumers

DIArsquos Annual Canadian Meeting Thinking Globally Acting Locally for the Well-Being of the PatientTutorials October 27 | Meeting October 28-29Ottawa Ontario Canada

2

DIArsquoS CERTIFICATE PROGRAM bull Clinical Research Certificate Program 7 Elective Units

bull Clinical Safety and Pharmacovigilance Certificate Program 4 Elective Units

bull Project Management Certificate Program 8 Elective Units

bull Regulatory Affairs Certificate Program 7 Elective Units

For more information go to DIAHomeorgcertificateprograms

TO ACCESS PRESENTATIONSbull Visit DIAHomeorg

bull Login to My DIA

bull Enter your User ID and Password

bull View lsquoMy Presentation Downloadsrsquo

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

CONTINUING EDUCATION CREDITS

DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education This program is designated for up to 9 contact hours or 09 continuing education units (CEUrsquos) Type of Activity Knowledge

ACPE Credit Request UpdateDIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system All ACPE-certified activity credit requests need to be submitted through DIArsquos My Transcript within 45-days post activity Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly If you need to obtain your NABP e-Profile please visit wwwcpemonitornet

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 ANSIIACET Standard DIA is authorized by IACET to offer up to 14 CEUs for this program Participants must attend the entire meeting lttutorial if applicablegt 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 you must attend the meeting and tutorial if applicable sign in at the DIA registration desk each day and complete the on line credit request process through My Transcript To access My Transcript please go to wwwdiahomeorg select ldquoLogin to My DIArdquo and you will be prompted for your user ID and password Select ldquoMy Transcriptrdquo (left side bar) and ldquoCredit Requestrdquo 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

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 andor the educational activity and (2) discussions of unlabeled or unapproved uses of drugs or medical devices Disclosure statements will be included in the meeting materials

Unless otherwise disclosed the statements made by speakers represent their own opinions and not necessarily those of the organization they represent or that of DIA 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

To view DIArsquos Grievance Policy please visit the CE page on DIArsquos website at wwwDIAHomeorgCE

CONTINUING EDUCATION CREDIT ALLOCATION

Tutorial Risk Management Plans and Drug Utilization Studies in Canada IACET 3 CEUsTutorial Non-Inferiority Trials-Design and Analysis Issues IACET 3 CEUsMeeting Pharmacy up to 9 contact hours or 09 CEUs IACET 11 CEUs

Pharmacy Credit Breakdown

bull Plenary Session 1 Putting Patients First What Does It Look Like in 2014 to be a Patient-Centric Organization - Part 1 15 contact hours or 15 CEUs 0286-0000-14-084-L04-P


bull Session 3 - Track C Patient Access 15 contact hours or 15 CEUs 0286-0000-14-086-L04-P

bull Session 4 - Track C Communication to Patients and PublicConsumer 15 contact hours or 15 CEUs 0286-0000-14-087-L04-P

bull Session 5 - Track C Health Technology Assessments 15 contact hours or 15 CEUs 0286-0000-14-088-L04-P

bull Session 6 - Track C Simplifying Clinical Trial Execution in Canada in the Interest of Patients 15 contact hours or 15 CEUs 0286-0000-14-089-L04-P

3

Drug Safety Is Your Staff Prepared

DIArsquos Drug Safety eLearning Program is Your Training Solution to Reduce Risk

Drug safety is a primary concern throughout the medical product development life cycle Developed with DIA expertise to meet the unique needs of its stakeholders and members this online safety program provides the knowledge your staff needs from regulations and requirements through premarket review and postmarket monitoring

Make Sure Your Staff is Ready

Enroll today at diahomeorgsafetyelearning or contact KatieHilldiahomeorg for information on group discounts and licensing

Drug Safety Training in Six Modules

Use these self-paced modules to meet your individual or

organizationrsquos training needs

Introduction to Drug Safety

Drug Safety Regulatory Requirements

Premarketing Clinical Trial Safety

Postmarketing Safety Management

Basics of Signal Detection and Pharmacoepidemiology

Safety Audits and Inspections (Available in October)

Save NowBuy all 6 modules and get

20 off individual pricesGroup discounts and licensing available for 10 or more users

MONDAY OCTOBER 27

130-500pm TUTORIAL

Tutorial 1 - Risk Management Plans and Drug Utilization Studies in Canada Instructors

Rita CassolaExecutive Director PVCertus PV

Lucye GalandScientific ManagerHealth Canada

Sarah Frise PhDDirectorPatient Safety and Medical InformationAstraZeneca Canada IncAdjunct Faculty Dalla Lana School of Public HealthUniversity of Toronto

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 ldquoRisk Management Plans and Follow-up Commitmentsrdquo 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

Learning Objectives

At the conclusion of this activity participants should be able to

bull Explain Health Canada expectations in relations to Risk Management Plans

bull Discuss main principles and limitations of DUS

bull Explain Health Canada expectations of DUS

bull Recognize situations where alternatives can be considered when full DUS are not attainable

Thank You to Our Media Partners

4

TUESDAY OCTOBER 28

700-810am CONTINENTAL BREAKFAST

810-815am OPENING REMARKS

Co PhamSenior Scientific Advisor Director Generalrsquos OfficeMarketed Health Products DirectorateHealth Canada

815-830am WELCOMING ADDRESS

Anil AroraAssistant Deputy MinisterHealth Canada

830-1000am SESSION 1 PLENARY SESSION PUTTING PATIENTS FIRST WHAT DOES IT LOOK LIKE IN 2014 TO BE A PATIENT-CENTRIC ORGANIZATION (PART 1)

sessIon chaIr

Co Pham Senior Scientific AdvisorDirector Generalrsquos OfficeMarketed Health Products DirectorateHealth Canada

Part 1 of this plenary session will focus on the regulatory perspective of being a patient-centric organization

speakers

Supriya Sharma MD MPH FRCPCAssociate Assistant Deputy Minister of Health Products and Food BranchHealth Canada

Federico Feldstein JDVice PresidentMedical Regulatory CompliancePfizer Inc

Robin ChiponskiDirector General of the Inspectorate of HPFBHealth Canada

1000-1030am REFRESHMENT BREAK

1030am-1200pm SESSION 2 PLENARY SESSION PUTTING PATIENTS FIRST WHAT DOES IT LOOK LIKE IN 2014 TO BE A PATIENT-CENTRIC ORGANIZATION (PART 2)

sessIon chaIr


Part 2 of this plenary session will focus on the health care patient organization and payer perspective of being a patient-centric organization

speakers

Uncoordinated Ethical Insights About Patient Participation Bernard Keating PhDProfessor Director of Applied Ethics ProgramsFaculty of Theology and Religious StudiesLaval University

Partnering with Patients in Healthcare Decision Making Durhane Wong-Rieger PhD MAPresident and Chief Executive OfficerCanadian Organization For Rare Disorders (CORD)

Patient Input and Evidence-Brining Life to Health Technology Assessment Reviews Chander Sehgal MD MBADirectorCDR and Rapid ResponseCanadian Agency for Drugs and Technologies in Health (CADTH)

1200-130pm LUNCH


5

130-300pm SESSION 3

TRACK A

Communications With Regulators and Among IndustrysessIon chaIr


Good communication between industry and regulators is a cornerstone of predictable process and outcome in review and regulatory decision making of all regulatory files as well as in consultation on new or updating regulations guidances and policies The session will primarily provide overview of key principles and challenges during the first cycle review in Canada and US with reflection on possible evolution and improvements It will be complemented by learnings from Health Canada effective risk communication needs planning and process

speakers

Agency and Industry Perspectives on FDA Regulatory Review Transparency and Communication Jayne C Ware MS MPHDirectorGlobal Regulatory PolicyMerck amp Co Inc

Loretta Del BoscoDirectorRA amp QA OperationsAbbVie Corporation

Health Canadarsquos Risk Communication ApproachMatthew BownAssociate DirectorMarketed Health Products DirectorateHealth Canada

TRACK B

Vendor ManagementsessIon chaIr


Suppliers and 3rd parties play a key role in todayrsquos 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 projectrsquos life cycle

From the Vertical to Horizontal Integration Benefits and Pitfalls of Outsourcing ManufacturingMohammed Razdar KhanPrincipalSynergex Consulting

Vendor Oversight for Small and Medium Sized Sponsors Methods to Achieve Operational Compliance and Business ObjectivesPeter MotteramDirectorPASM Limited

Vendors in Clinical DevelopmentLoubaba CherkaouiPharma GCP AuditorGlobal Development Quality Assurance Audit ExpertNovartis Pharmaceuticals Canada Inc

TRACK C

Patient AccesssessIon chaIr


The research-based pharmaceutical industry is driven to produce innovative medicines that will benefit patients However regulatory approval of a drug for sale in Canada does not necessarily mean that provincial and territorial governments will fund it Therefore while ensuring prompt and equitable patient access to innovative medicines is a major concern to key stakeholders the Canadian pharmaceutical and biotechnology industry is faced with the challenge of having to reconcile the needs of patients to have access to important new treatments the requirement of the payer to manage scarce resources and the constraints of the companies that discover these innovations This session will look at the broad spectrum of the drug approval process from the regulatory payer (specifically how evidence-based information influences decision makers) and industry perspectives From the review of new drug submissions to provincialterritorial decision for product listing and everything in between each of the speakers will discuss their role in making inroads to improve and facilitate access to medicines including non traditionalaccelerated pathways investigational access and trends in orphan drugsrare diseases

Speakers will address this important topic How can we ensure the continuous access of patients to quality and state-of-the art medicines

Access to Drug Therapies - Health Canadarsquos Role Initiatives and ChallengesJohn Patrick Stewart MDExecutive Medical Director of Therapeutic Products DirectorateHealth Canada

Pan-Canadian Approach for Public Drug Program Funding RecommendationsBrent FraserDirectorDrug Program Services OPDPOntario Ministry of Health

Achieving Market Access Success ndash A Manufacturerrsquos PerspectiveLindy FortePrincipal ConsultantPatient Access Solutions

6

300-330pm REFRESHMENT BREAK

330-500pm SESSION 4

TRACK A

Unique Regulatory Requirements in CanadasessIon chaIr

Rocelyn DelCarmenHarmonization 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 ldquoact locallyrdquo to address it

Bioequivalence ndash Health Canadarsquos PerspectivePaul WielowleyskiActing Manager of the Division of Biopharmaceuticals EvaluationBureau of Pharmaceutical ScienceHealth Canada

Impact of Canadian Specific Requirements for CRFsSamar DarwishDirectorRegulatory Affairs and Drug SafetyBoehringer Ingelheim Canada

Health Canada Regulations ndash The Nuts and Bolts Importation and Release of Drug ProductsDavid LessardDirector of Quality and CompliancePfizer Canada Inc

TRACK B

GVP InspectionssessIon chaIr

Chanez KebacheManagerPharmacovigilanceMallinckrodt Pharmaceutical

As part of Health Canadarsquos (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 HCrsquos website the new guidance document entitled ldquoGood Pharmacovigilance Practices (GVP) Guidelinesrdquo (GUI-0102) and the revision to the ldquoRisk Classification of Good Pharmacovigilance Practices (GVP) Observationsrdquo (GUI-0063)

The industryrsquos 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 HCrsquos Inspectorate representative will provide an overview of the main deficiencies observed during GVP inspections that have been conducted since the implementation of GUI-0102

speakers

Sophie LafranceCompliance OfficerHPFB InspectorateHealth Canada

Agnes Jankowicz Executive Director PVCertus PV Services Inc

panelIst

Robert MilneManager Drug safetyMedical InformationEMDSerono (QampA portion only)

TRACK C

Communication to Patients and PublicConsumersessIon chaIr

Janice Lobo-DaleRegulatory AnalystBiologics and Genetic Therapies DirectorateHealth Canada

With a focus on transparency and openness for increased health benefits and mitigated health risks regulatory agencies in consultation with drug manufacturers and in collaboration with other key stakeholders and partners are strengthening the approach taken to communicate with patients and consumers This session will focus on initiatives taken by government agencies and drug manufacturers to make available drug product information in plain language The concept of available clear comprehensive and useful information related to authorized medicines is guiding strategies for improved guidance new regulations and increased communication for the well-being of patientsconsumers

speakers

Denis MulhallExecutive DirectorIMITHealth Canada

Durhane Wong-Rieger PhD MAPresident and Chief Executive OfficerCanadian Organization For Rare Disorders (CORD) Canada

Recent FDA Activities Related to Communicating Medical Information to ConsumersJayne C Ware MS MPHDirectorGlobal Regulatory PolicyMerck amp Co Inc

500-600pm NETWORKING RECEPTION

Connect with us DrugInfoAssn

7

WEDNESDAY OCTOBER 29


830-1000am SESSION 5

TRACK A

Transforming Drug Safety and SurveillancesessIon chaIr

Rocelyn DelCarmenDirectorRegulatory Affairs and Quality AssuranceAstraZeneca Inc

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

Continuous Improvement Efforts by Health Canada to Enhance the Human Cells Tissues and Organs Surveillance System in CanadaMelanie Cassandre Derry MDScientific EvaluatorHealth Canada

Implementing C17 Update and Next Steps-Health Canada PerspectiveDavid K LeeDirectorOffice of Legislative and Regulatory ModernizationHealth Canada

Implementing C17 Opportunities and Challenges-Industry PerspectiveKeith McIntoshSenior DirectorScientific amp Regulatory AffairsCanadarsquos Research-Based Pharmaceutical Companies (RxampD)

TRACK B

New Technologies and Evolving Science as a Challenge to Regulatory FrameworksessIon chaIr

Matt RyanSenior AdvisorDirector Generalrsquos OfficeTherapeutic Productrsquos DirectorateHealth CanadaNew technologies and evolving science are critical to the advancement of health care and treatment options for patients Researchers academia and the pharmaceutical industry have all played a significant role in bringing new drug and medical device technologies to market leading to increased health benefits for Canadian patients Even moreso today scientific and technological advancements are being developed at a rapid pace requiring effective support in order to advance from discovery through development and into commercialization Some of these advancements fit well into existing regulatory frameworks while others present challenges and even potential barriers to what is needed in todayrsquos environment The regulator is also faced with challenges in using existing regulations in the application of science and technological advancements that could not have been foreseen even a few years Speakers will present on these new challenges and how they are being addressed under todayrsquos regulatory environment and how we need to re-think our approaches to these scientific and technical opportunities While there are challenges there are also opportunities for all areas of the pharmaceutical spectrum including from both Industry and governments to play a leadership role in facilitating science and regulation in the development of safe and effective drug therapies

Overview of Health Canadarsquos Initiatives in Tamper-Resistance and Abuse DeterrenceKimby Barton MScDirector of Bureau of Cardiology Allergy and Neurological SciencesHealth Canada

New Technologies and Evolving Science as an Opportunity for the Regulatory FrameworkBarbara E Tardiff MDVice President Development Operations Global Head Clinical Innovation and Informatics Worldwide Research amp Development

Overview of Canadian Guidance Documents on Rare DiseasesAgnes KleinDirectorEvaluation of Radiopharmaceuticals and Biotherapeutic ProductsHealth Canada

TRACK C

Health Technology AssessmentssessIon chaIr


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 haveare 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

speakers

Chander Sehgal MD MBADirectorCDR and Rapid ResponseCanadian Agency for Drugs and Technologies in Health (CADTH)

Thomas HollowayPresidentEquitus Consulting Inc

Patient Perspective on How Pharmacoeconomic Evaluations are Blocking Patient Access to MedicinesWayne CritchleySenior AssociateHealth amp Life SciencesGlobal Public Affairs

8


1030am-1200pm SESSION 6

TRACK A

Subsequent Entry BiologicsBiosimilarssessIon chaIr

Andrew StoreyVice PresidentRegulatory Affairs United States and CanadaAbbVie

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 ldquosimilarityrdquo 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

speakers

Agnes KleinDirectorEvaluation of Radiopharmaceuticals and Biotherapeutic ProductsHealth Canada

Navigating the Marketing Application Process to Subsequent Entry BiologicsAllison Guy MSc RACConsultantPAREXEL International

Christopher ShanneSr ConsultantPAREXEL International

Keith WatsonDirectorAbbVie Ltd

Brendan McIntoshCanadian Agency for Drugs and Technologies in Health (CADTH)

TRACK B

BiostatisticssessIon chaIr


The sessionrsquos objectives is to present the challenges of using the statistics from the drug development plan across the lifecycle of the product Clinical development plans are geared towards product approval in a given region and are based on the health authoritiesrsquo requirements and international standards In Canada these statistical measures will be used to demonstrate the benefit of the drug to various decision-makers at the national and provincial level and also with prescribers In large multinational companies these data may (or may not) fit the needs of the Canadian environment in the pre-market and post-market phase The speakers will include a Health Canada perspective on evaluating statistical evidence generated at an international level to a Canadian context an industry talk on interfacing with the various stakeholders to ensure alignment of need for informed decision-making and from an advertising review agency on how best to use the stats you have to communicate the benefits of the drug to a healthcare professional

speakers

Evaluating Statistical Evidence Generated at an International Level A Regulatory Perspective Catherine Njue PhDBiostatistics Advisor - Clinical TrialsCentre for Evaluation of Radiopharmaceuticals and BiotherapeuticsHealth Canada

Patrick MassadChief Review OfficerPharmaceutical Advertising Advisory Board (PAAB)

John StewartManager BiostatisticsSanofi-Aventis Canada Inc

TRACK C

Simplifying Clinical Trial Execution in Canada in the Interest of PatientssessIon chaIr


With continued focus on safety and efficacy of medicines and the well-being of the patientcon-sumer global considerations for efficient clinical trial infrastructure places an emphasis on best practices for managing a successful clinical trial life cycle and a streamlined clinical regulatory environment in which consolidated ethics review and appropriate guidelines are shared and clearly understood

Best Practices for Managing Successful Clinical amp Pharmaceutical ProjectsZizi ImatorbhebhePrincipalAlliance Bio-Pharm amp Health Partners

Clinical Trials in Canada Extraterritorial Application of US Laws and RegulationsJack CormanManaging DirectorIRB Services

The Initiative to Streamline Investigator Initiated Clinical Trials Guidelines for Managing Canadian Regulatory Expectations Karen Arts MSN RN CCRCDirectorBusiness DevelopmentHigh Impact Clinical TrialsOntario Institute for Cancer Research

1200-130pm LUNCH


9

130-300pm CLOSING PLENARY SESSION

Evolving the Healthcare and the Therapeutic Options by Putting Patients First sessIon chaIrs


Vratislav HadravaVice President and Medical DirectorGlobal Innovative ProductsPfizer Canada Inc

This final plenary session will focus on the patient perspective and how industry health care professionals and regulators can work together to translate knowledge to the patient Presentations will be given by a patient representative health care providereducator and a regulator

speakers

Patient PerspectiveMaureen SmithSecretaryCanadian Organization for Rare Disorders

Roland Halil MDAssistant ProfessorDepartment of Family MedicineUniversity of Ottawa

Closing RemarksKelvin Kenneth OgilvieSenatorChair of the Senate Standing Committee on Social Affairs Science and Technology

300pm MEETING ADJOURNS

2

DIArsquoS CERTIFICATE PROGRAM bull Clinical Research Certificate Program 7 Elective Units

bull Clinical Safety and Pharmacovigilance Certificate Program 4 Elective Units

bull Project Management Certificate Program 8 Elective Units

bull Regulatory Affairs Certificate Program 7 Elective Units

For more information go to DIAHomeorgcertificateprograms

TO ACCESS PRESENTATIONSbull Visit DIAHomeorg

bull Login to My DIA

bull Enter your User ID and Password

bull View lsquoMy Presentation Downloadsrsquo

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

CONTINUING EDUCATION CREDITS

DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education This program is designated for up to 9 contact hours or 09 continuing education units (CEUrsquos) Type of Activity Knowledge

ACPE Credit Request UpdateDIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system All ACPE-certified activity credit requests need to be submitted through DIArsquos My Transcript within 45-days post activity Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly If you need to obtain your NABP e-Profile please visit wwwcpemonitornet

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 ANSIIACET Standard DIA is authorized by IACET to offer up to 14 CEUs for this program Participants must attend the entire meeting lttutorial if applicablegt 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 you must attend the meeting and tutorial if applicable sign in at the DIA registration desk each day and complete the on line credit request process through My Transcript To access My Transcript please go to wwwdiahomeorg select ldquoLogin to My DIArdquo and you will be prompted for your user ID and password Select ldquoMy Transcriptrdquo (left side bar) and ldquoCredit Requestrdquo 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

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 andor the educational activity and (2) discussions of unlabeled or unapproved uses of drugs or medical devices Disclosure statements will be included in the meeting materials

Unless otherwise disclosed the statements made by speakers represent their own opinions and not necessarily those of the organization they represent or that of DIA 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

To view DIArsquos Grievance Policy please visit the CE page on DIArsquos website at wwwDIAHomeorgCE

CONTINUING EDUCATION CREDIT ALLOCATION

Tutorial Risk Management Plans and Drug Utilization Studies in Canada IACET 3 CEUsTutorial Non-Inferiority Trials-Design and Analysis Issues IACET 3 CEUsMeeting Pharmacy up to 9 contact hours or 09 CEUs IACET 11 CEUs

Pharmacy Credit Breakdown



bull Session 3 - Track C Patient Access 15 contact hours or 15 CEUs 0286-0000-14-086-L04-P

bull Session 4 - Track C Communication to Patients and PublicConsumer 15 contact hours or 15 CEUs 0286-0000-14-087-L04-P

bull Session 5 - Track C Health Technology Assessments 15 contact hours or 15 CEUs 0286-0000-14-088-L04-P

bull Session 6 - Track C Simplifying Clinical Trial Execution in Canada in the Interest of Patients 15 contact hours or 15 CEUs 0286-0000-14-089-L04-P

3

















MONDAY OCTOBER 27

130-500pm TUTORIAL






Learning Objectives







4

TUESDAY OCTOBER 28







sessIon chaIr



speakers






sessIon chaIr



speakers




1200-130pm LUNCH


5

130-300pm SESSION 3

TRACK A




speakers




TRACK B







TRACK C








6


330-500pm SESSION 4

TRACK A






TRACK B





speakers



panelIst


TRACK C




speakers






7




TRACK A







TRACK B






TRACK C




speakers




8



TRACK A





speakers






TRACK B




speakers




TRACK C







1200-130pm LUNCH


9






speakers





3

















MONDAY OCTOBER 27

130-500pm TUTORIAL






Learning Objectives







4

TUESDAY OCTOBER 28







sessIon chaIr



speakers






sessIon chaIr



speakers




1200-130pm LUNCH


5

130-300pm SESSION 3

TRACK A




speakers




TRACK B







TRACK C








6


330-500pm SESSION 4

TRACK A






TRACK B





speakers



panelIst


TRACK C




speakers






7




TRACK A







TRACK B






TRACK C




speakers




8



TRACK A





speakers






TRACK B




speakers




TRACK C







1200-130pm LUNCH


9






speakers





4

TUESDAY OCTOBER 28







sessIon chaIr



speakers






sessIon chaIr



speakers




1200-130pm LUNCH


5

130-300pm SESSION 3

TRACK A




speakers




TRACK B







TRACK C








6


330-500pm SESSION 4

TRACK A






TRACK B





speakers



panelIst


TRACK C




speakers






7




TRACK A







TRACK B






TRACK C




speakers




8



TRACK A





speakers






TRACK B




speakers




TRACK C







1200-130pm LUNCH


9






speakers





5

130-300pm SESSION 3

TRACK A




speakers




TRACK B







TRACK C








6


330-500pm SESSION 4

TRACK A






TRACK B





speakers



panelIst


TRACK C




speakers






7




TRACK A







TRACK B






TRACK C




speakers




8



TRACK A





speakers






TRACK B




speakers




TRACK C







1200-130pm LUNCH


9






speakers





6


330-500pm SESSION 4

TRACK A






TRACK B





speakers



panelIst


TRACK C




speakers






7




TRACK A







TRACK B






TRACK C




speakers




8



TRACK A





speakers






TRACK B




speakers




TRACK C







1200-130pm LUNCH


9






speakers





7




TRACK A







TRACK B






TRACK C




speakers




8



TRACK A





speakers






TRACK B




speakers




TRACK C







1200-130pm LUNCH


9






speakers





8



TRACK A





speakers






TRACK B




speakers




TRACK C







1200-130pm LUNCH


9






speakers





9






speakers





DIA’s Annual Canadian Meeting: Thinking Globally, Acting Locally … cycle management of the...

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Transcript of DIA’s Annual Canadian Meeting: Thinking Globally, Acting Locally … cycle management of the...