9th Annual Biomarkers Congress
DIA's 6th Canadian Annual Meeting: Benefit and Risk Management: An Evolution in Progress
Westin Ottawa Hotel,
11 Colonel By Drive,
Ottawa, Ontario, Canada
http://www.diahome.org
DIA's 6th Canadian Annual Meeting: Benefit and Risk Management: An Evolution in Progress  
Drug Information Association
http://www.diahome.org
Westin Ottawa Hotel,

Schedule of Presentations:

Wednesday, November 5, 2008
11:00:00 Tutorial Registration
12:00:00 Exhibitor Set-up and Registration
13:30:00 Tutorials ( 1 & 2)
13:35:00 Tutorial #2: Innovative/Adaptive Designs for Clinical Trials: Applicability – Risks – Benefits Miklos L. , Schulz, St. Clare Chung
13:35:00 Tutorial #1: Risk Management Planning: Strategies and Tools for Development and Implementation Yola , Moride
13:45:00 Tutorial #1: Tutorial Target Audience:
14:00:00 Tutorial #2: Tutorial Learning Objectives: At the conclusion of this tutorial, participants should be able to:
14:20:00 Tutorial #2: Tutorial Target Audience:
14:30:00 Tutorial #1: Tutorial Learning Objectives: At the conclusion of this tutorial, participants should be able to:
16:00:00 Meeting Registration
Thursday, November 6, 2008
07:30:00 Registration and Continental Breakfast
08:15:00 OPENING REMARKS
08:15:00 CANADIAN STEERING COMMITTEE RAV KUMAR
08:15:00 DIA WELCOME JUDITH , GLENNIE
08:30:00 OPENING PLENARY SESSION
08:35:00 COMMUNICATION OF BENEFIT/RISK (SAFETY ISSUES) DAVID , KRAKOVSKY
08:45:00 THE ROLE AND INFLUENCE OF THE MEDIA André Picard
09:00:00 THE PERSPECTIVE OF THE PHARMACEUTICAL INDUSTRY Karen , Burke
09:00:00 EXPERIENCES OF A PATIENT Linda Wilhelm
09:10:00 THE ROLE OF THE PHYSICIAN IN BENEFIT/RISK COMMUNICATIONS Michael , Rieder
10:00:00 Refreshment Break in the Exhibit Hall (Hall opens at 9:30 AM)
10:30:00 THE EVOLVING LANDSCAPE OF BENEFIT AND RISK MANAGEMENT: HOW IS HEALTH CANADA ADAPTING? Marc Berthiaume
10:30:00 OPENING PLENARY SESSION
10:35:00 HEALTH CANADA’S HEALTH PRODUCTS AND FOOD BRANCH STRATEGIC PLAN Meena Ballantyne
10:40:00 MARKETED HEALTH PRODUCTS DIRECTORATE’S (MHPD) CURRENT AND FUTURE ORIENTATIONS Chris , Turner
10:45:00 PLANS TO ESTABLISH A PAN-CANADIAN DRUG SAFETY AND EFFECTIVENESS NETWORK Cynthia , Sunstrum
12:00:00 UPDATE ON PROGRESSIVE LICENSING
12:00:00 Luncheon in the Exhibit Hall
13:30:00 BIOLOGICS : TRACK 3
13:30:00 PARALLEL TRACKS ( 1, 2 and 3)
13:35:00 TRACK 1 : Session Chairs
13:35:00 TRACK 1 : CHALLENGES IN EVIDENCE GENERATION AND UPTAKE IN THE REAL-WORLD ENVIRONMENT – PART 1
13:35:00 TRACK 2 : PHARMACOVIGILANCE PLANNING – PART 1
13:35:00 TRACK 3 : Session Chair
13:35:00 TRACK 2 : Session Chairs
13:40:00 TRACK 2 : INTRODUCTION TO MEDDRA® Judy , Harrison
13:40:00 TRACK 1 : OUTLINING THE ISSUES AND CHALLENGES IN EVIDENCE GENERATION TO MEET DECISIONMAKER NEEDS JUDITH , GLENNIE
13:45:00 TRACK 1 : BEYOND SAFETY EVIDENCE IN THE POSTMARKETING ENVIRONMENT: THERAPEUTIC EFFECTIVENESS AT THE REGULATORY LEVEL Cindy Evans
13:45:00 TRACK 3 : HEALTH CANADA’S APPROACH TO REGULATING SEBS (SUBSEQUENT ENTRY BIOLOGICS) Kwasi , Nyarko
14:00:00 TRACK 1 : TOWARDS A FRAMEWORK FOR POST-MARKETING STUDIES: MATCHING THE QUESTION TO THE DESIGN Cynthia Verst
14:00:00 TRACK 3 : AN INNOVATOR’S PERSPECTIVES ON SEB ISSUES Andrew Fox
14:00:00 TRACK 2 : CANADA VIGILANCE: IMPLEMENTATION OF A NEW PHARMACOVIGILANCE INFORMATION SYSTEM AT HEALTH CANADA Heather Sutcliffe
14:00:00 TRACK 2 : MEDDRA® IMPLEMENTATION WITHIN CANADA VIGILANCE AT HEALTH CANADA Michelle , Slow
14:05:00 TRACK 3 : HOW DOES INDUSTRY OBTAIN REGULATORY APPROVALS ON SEBS? Yafit , Stark
15:00:00 Refreshment Break in the Exhibit Hall
15:30:00 TRACK 2 : RISK MANAGEMENT PLANNING
15:30:00 PARALLEL TRACKS continued
15:30:00 TRACK 1: PROGRESSIVE DRUG DEVELOPMENT – PART 1
15:35:00 TRACK 1 : NEW APPROACHES TO ANIMAL MODELS OF DISEASE AND TOXICOLOGY TESTING Glenn Washer
15:35:00 TRACK 1 : THE CRITICAL PATH INITIATIVE Anne Tomalin ANNE TOMALIN
15:35:00 TRACK 2 : Session Chair
16:00:00 TRACK 1 : CLINICAL TRIALS TRANSFORMATION INITIATIVE Alberto , Grignolo
16:00:00 TRACK 3: NATURAL HEALTH PRODUCTS – PART 1
16:00:00 TRACK 3 : Session Chair
16:00:00 TRACK 2 : BEST PRACTICE IN GLOBAL PHARMACEUTICAL RISK MANAGEMENT PLANNING Mary , Frances Schubert
16:00:00 TRACK 2 : BEST PRACTICE IN GLOBAL PHARMACEUTICAL RISK MANAGEMENT PLANNING Mary , Frances Schubert
16:05:00 TRACK 2 : TOWARDS COMPREHENSIVE RISK MANAGEMENT PLANNING: HEALTH CANADA’S PROPOSED APPROACH Kimby N. Barton
16:05:00 TRACK 3 : VIGILANCE OF NATURAL HEALTH PRODUCTS Mano , Murty
16:10:00 TRACK 3 : NATURAL HEALTH PRODUCTS: EXPLORING THE EFFICACY, SAFETY AND QUALITY? MOHAMMED RAZDAR KHAN
16:15:00 TRACK 3 : ADULTERATION AND CONTAMINATION OF NATURAL HEALTH PRODUCTS: REGULATORY ISSUES AND CHALLENGES Harpal S. , Buttar
17:00:00 Networking Reception
18:30:00 End Of The Session
Friday, November 7, 2008
07:30:00 Registration and Continental Breakfast
08:25:00 Session Chair
08:30:00 TRACK 1 : CHALLENGES IN EVIDENCE GENERATION AND UPTAKE IN THE REAL-WORLD ENVIRONMENT – PART 2
08:30:00 PARALLEL TRACKS ( 1, 2 and 3)
08:35:00 TRACK 1 : Session Chairs
08:35:00 TRACK 3 : MEDICAL RISK COMMUNICATIONS
08:35:00 TRACK 2 : PHARMACOVIGILANCE PLANNING – PART 2
08:40:00 TRACK 2 : Session Chair
08:50:00 TRACK 3 : THE REGULATOR’S PERSPECTIVE Ilhemme Djelouah
09:00:00 TRACK 1 : UNLEASHING THE VALUE OF REAL-WORLD DATA AND METHODS TO IMPROVE HEALTH CARE DECISION MAKING Richard , Gliklich
09:10:00 TRACK 2 : OPTIMISING BENEFITS AND MINIMISING RISKS OF DRUGS FOR PATIENTS: A PROPOSED WAY FORWARD Robyn Lim
09:10:00 TRACK 1 : CREATING SUCCESS FOR THE LONG TERM: KEY LEARNINGS FROM AND APPLICATIONS OF THE MACSTRAK (MANAGING THE ACUTE CORONARY SYNDROMES) PROJECT Paul A. , Daly
09:15:00 TRACK 3 : THE HEALTH PROFESSIONAL PERSPECTIVE Eric , Wooltorton
09:25:00 TRACK 2 : RISK MANAGEMENT PLANS AND TOOLBOX: OPPORTUNITIES FOR CANADA Yola , Moride
09:30:00 TRACK 3 : THE INDUSTRY PERSPECTIVE Jane Shum
09:30:00 TRACK 1 : DEVELOPING REGISTRIES IN THE CANADIAN CONTEXT Frank Shannon
09:30:00 TRACK 3 : THE CONSUMER’S PERSPECTIVE Janet Currie
09:30:00 TRACK 2 : PATIENT RISK MANAGEMENT PLANS: AN EU-US PERSPECTIVE Linda , Warner
10:00:00 Refreshment Break in the Exhibit Hall
10:30:00 PARALLEL TRACKS continued
10:30:00 TRACK 1 : PROGRESSIVE DRUG DEVELOPMENT – PART 2
10:30:00 TRACK 2 : SCIENTIFIC AND REGULATORY CHALLENGES OF DRUG/DEVICE COMBINATION PRODUCTS
10:35:00 TRACK 2 : Session Chair
10:35:00 TRACK 1 : Session Chair
10:40:00 TRACK 3 : QBD “CONTINUOUS IMPROVEMENT”
10:40:00 TRACK 3 : Session Chair
10:45:00 TRACK 1 : NEW APPROACHES TO DRUG DEVELOPMENT – PERSONALIZED MEDICINES Bernard , Chiasson
10:45:00 TRACK 3 : DRUG SUBSTANCE DESIGN SPACE: APPLYING THE CONCEPTS Alan , Watt
10:50:00 TRACK 1 : USE OF BIOMARKERS TO MEASURE THE PROGRESS OF DISEASE IN CLINICAL TRIALS AGNES V. , KLEIN
10:55:00 TRACK 1 : USE OF IMAGING TO DETERMINE EFFICACY Gordon Mills
10:55:00 TRACK 3 : QBD APPLIED TO BIOLOGICS Jennifer Mercer
11:15:00 TRACK 3 : DRUG PRODUCT LIFECYCLE MANAGEMENT THROUGH PRODUCT DEVELOPMENT Krishnan , Tirunellai
11:40:00 TRACK 2 : Speakers Brigitte Zirger, Fannie St-Gelais, Guy Beaulieu
12:00:00 Luncheon in the Exhibit Hall (Hall closes 1:30 PM)
13:00:00 TRACK 3 : NATURAL HEALTH PRODUCTS – PART 2
13:00:00 TRACK 2 : ESUBMISSIONS/DOCUMENT MANAGEMENT
13:00:00 PARALLEL TRACKS continued
13:00:00 TRACK 1 : INTERNATIONAL REGULATORY COOPERATION – A CHANGING WORLD
13:05:00 TRACK 1 : Session Chair
13:05:00 TRACK 3 : Session Chair
13:15:00 TRACK 1 : Speakers Mike D. Ward, Charles A. Gaylord, Kimberly Empey
13:30:00 TRACK 2 : Session Chair
13:30:00 TRACK 3 : HEALTH CANADA’S NATURAL HEALTH PRODUCTS PROGRAM: BLACK COHOSH AS A CASE STUDY OF WORKING TOGETHER TO INCREASE PRODUCT SAFETY Scott A. , Jordan
13:35:00 TRACK 3 : MONITORING NHP ADVERSE REACTIONS: A SHARED RESPONSIBILITY BETWEEN THE REGULATOR, CONSUMER, HEALTH PROFESSIONAL, AND THE INDUSTRY Scott A. , Jordan
13:40:00 TRACK 2 : EXPERIENCES WITH THE HYBRID ECTD: A REGULATORY PERSPECTIVE Claire-Marie Wray,
13:50:00 TRACK 2 : PLANS FOR SECURE ELECTRONIC TWO-WAY COMMUNICATION Douglas S. Watson
14:05:00 TRACK 3 : PHARMACY SONAR (STUDY OF NATURAL HEALTH PRODUCT ADVERSE REACTIONS): ACTIVE SURVEILLANCE IN COMMUNITY PHARMACIES Sunita , Vohra
14:20:00 TRACK 2 : PLANS FOR ELECTRONIC CLINICAL TRIAL APPLICATIONS (CTA) REQUIREMENTS Martin Bernard
14:30:00 Canadian Annual Meeting Adjourned
4th Annual Pharma R&D Asia Congress
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