Program Overview
New Insights Into the Current Issues and Associated Challenges Impacting Drug Safety.
Top pharmaceutical, biotech, and regulatory representatives will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use, new and updated legislation in various ICH regions, important new harmonization initiatives, life cycle management, the impact of social media, biosimilars, and the use of other data sources and observational research. This program will focus primarily on drug products and biologics.
Featured Topics
- Regulatory Day
- New European, US, and Japanese Legislation
- New Harmonization Initiatives
- Risk Management/Life Cycle Management
- REMS
- Translating Pre-clinical Findings into Human Use
- Benefit-risk Optimization
- Social Media
- Pharmacoepidemiology
Learning Objectives
At the conclusion of this meeting, participants should be able to:
- Describe the latest regulatory framework for pharmacovigilance in the US, Europe, and Japan
- Discuss new safety harmonization initiatives
- Describe best practices for improving risk management and life cycle management approaches
- Discuss how companies are using social media to investigate safety information in the context of regulatory obligations
- Explain how to use other data sources and observational research for effective safety analysis
Who Should Attend
Professionals involved in:
- Pharmacovigilance
- Risk Management
- Medical Product Safety Assessment
- Regulatory Affairs
- Clinical Research
- Data Analysis
- Pharmacoepidemiology
- Labeling
- Quality Assurance/Quality Control
- Compliance
- Medical Information
Event Information
Contact Ellen Diegel, Program Manager
Phone +215-293-5810,
Fax +1.215.442.6199, email Ellen.Diegel@diahome.org
Program Staff
Program Chairperson
Mariette Boerstoel-Streefland, MD, MBA, MS(epi)
Chief Safety Officer, Executive Director Pharmacovigilance
/ Risk Management
Forest Research Institute
Forest Laboratories Inc.
Program Committee
Jean-Pierre Clement, MD
Vice President and Head of International Pharmacovigilance
Global Medical Safety
Division of Johnson & Johnson Pharmaceutical R&D
William W. Gregory
Senior Director, Safety and Risk Management, Pfizer Inc.
Steve Jolley
Principal, SJ Pharma Consulting, Chairperson for Clinical
Safety and Pharmacovigilance SIAC
Valerie E. Simmons, MD, FFPM
EU QPPV Executive, Global Patient Safety
Eli Lilly & Company Ltd., United Kingdom
Melissa M Truffa, RPh
Associate Director
Office of Surveillance and Epidemiology/Division of
Pharmacovigilance II, CDER, FDA
Shinya Yamauchi
Operating Officer, Pharmacovigilance Department
Otsuka Pharmaceutical Co., Ltd., Japan
Continuing Education
Continuing Education Credits
This activity has been planned and implemented in
accordance with the Essential Areas and policies of the
Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of Postgraduate Institute for
Medicine (PIM) and the Drug Information Association. PIM is accredited by
the ACCME to provide continuing medical education for physicians.
PIM designates this live activity for a maximum of 21.75 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. This program is designated for up to 21.75
contact hours or 2.175 continuing education units (CEU's).
Type of Activity: Knowledge
Corexcel is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission
on Accreditation.
Corexcel designates this activity for a maximum of 25 contact hours.
Drug Information Association has been approved as an Authorized Provider by the International Association for Continuing
Education and Training (IACET), 8405 Greensboro Drive, Suite
800, McLean, VA 22102; (703) 506-3275.
Drug Information Association is authorized by IACET to offer 2.5 CEUs for this program.
If you would like to receive a statement of credit, you must attend the program and tutorial(s), if applicable, scan your name badge at the DIA registration desk each day of the program and tutorial(s) you attend and complete the on-line credit request process through My Transcript at www.diahome.org. 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 February 8, 2012.
Please Note: If you are interested in receiving ACPE or IACET credit and do not scan your name badge each day of the program or tutorial(s) if applicable, you will not receive CE credit as partial credit will not be awarded. In order to obtain credit, you must attend the program or tutorial(s) in its entirety.
Disclosure Policy
The Postgraduate Institute for Medicine (PIM) and DIA require instructors,
planners, managers and other individuals who are in a position to control
the content of this activity to disclose any real or apparent conflict of interest they may have as related to the content of this activity. All identified
conflicts of interest are thoroughly vetted by PIM and DIA for fair balance,
scientific objectivity of studies mentioned in the materials or used as the
basis for content, and appropriateness of patient care recommendations.
Continuing Education Credits Allocation
Tutorial #1 - Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art: 3.25 nursing contact hours; .3 IACET CEUs
Tutorial #2 - Development Safety Update Reports (DSURs): Principles and Practicalities: 3.25 nursing contact hours; .3 IACET CEUs
Tutorial #3 - Pharmacovigilance and Risk Management Planning: 286-000-12-002-L04-P: 3.25 pharmacy contact hours or .325 CEUs; 3.25 nursing contact hours; .3 IACET CEUs
Tutorial #4 – Optimization and Improving Operational Performance: 3.25 AMA PRA Category 1 Credit(s)™; 3.25 nursing contact hours; .3 IACET CEUs
CME: 18.5 AMA PRA Category 1 Credit(s)™
Nursing: 18.5 contact hours
IACET: 1.9 CEUs
Pharmacy:
January 23, 2012; 286-000-12-003-L04-P; 7 contact hours or .7 CEUs
January 24, 2012; 286-000-12-004-L04-P; 6.5 contact hours or .65 CEUs
January 25, 2012; 286-000-12-005-L04-P; 5 contact hours or .5 CEUs
Program Agenda
Tutorial Day Sunday, January 22, 2012
Please note that lunch is not served on tutorial day.
8:30 am-12:00 pm Tutorial #1 (Half Day)
Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art
Sally Van Doren, PharmD
President & Chief Executive Officer
BioSoteria, Inc.
Sheila Weiss Smith, PhD, MS, FISPE
Director, Center for Drug Safety
Professor, Pharmaceutical Health Services Research Department,
University of Maryland School of Pharmacy
Professor, Epidemiology and Preventative Medicine,
University of Maryland School of Medicine
Overview:
This tutorial will provide a review and practical application of data mining techniques to safety surveillance, its application in signal detection, and the critical role of clinical case assessment. An overview of strategies and specific case
studies will be presented.
Learning Objectives:
At the conclusion of this tutorial, participants should be able to:
- Recognize the basic concepts of data mining and principles of signal detection
- Identify specific applications of data mining technology
- Explain the role of clinical case assessment in signal evaluation
- Describe the strengths and limitations of data mining in performance high-quality pharmacovigilance
Target Audience:
This tutorial is designed for clinical safety professionals involved in the areas of pharmacovigilance, pharmacoepidemiology, regulatory affairs, quality assurance, medical product safety assessment, and labeling.
1:30-5:00 pm Tutorial #2 (Half Day)
Development Safety Update Reports (DSURs): Principles and Practicalities
Valerie E. Simmons, MD, FFPM
EU QPPV Executive, Global Patient Safety
Eli Lilly & Company Ltd., UK
Barry Arnold, MBBCh, FRCA, FFPM
EU QPPV, Astra Zeneca, UK
Michael Richardson
International Head GPV&E and EU QPPV
Bristol-Myers Squibb
Overview:
The new ICH E2F guideline on the Development Safety Update Report (DSUR) was signed off in August 2010 and came into force in Europe in September 2011. This new report will replace the current European clinical trial Annual Safety Report and, in the other ICH regions is intended to be a common standard for periodic reporting on drugs under development (including marketed drugs that are under further study.
Learning Objectives:
At the conclusion of this tutorial, participants should be able to:
- Discuss the main principles defined in the ICH E2F guideline
- Describe the structure and content of the DSUR
- Discuss on how a DSUR can be prepared
- Prepare for the implementation of the DSUR
Target Audience:
This tutorial is designed for sponsors of clinical trials, regulatory affairs staff of pharmaceutical companies, pharmacovigilance staff of pharmaceutical companies, and clinical development staff.
8:30 am-12:00 pm Tutorial #3 (Half Day)
Pharmacovigilance and Risk Management Planning
William W. Gregory
Senior Director, Safety and Risk Management
Pfizer Inc.
Robert Sharrar, MD
Executive Director, Safety, Epidemiology, Registries and Risk
Management
United BioSource Corporation
Overview:
This tutorial will cover basic approaches to risk management planning in the regulatory framework of the EU, Japan, and the US. The various components of Risk Management Plans, Risk Minimization Plans, Risk Evaluation and Mitigation Strategies for identified and potential risks will be covered.
Learning Objectives:
At the conclusion of this tutorial, participants should be able to:
- Discuss similarities and differences in the risk management planning in the three ICH regions
- Describe the differences between identified and potential risks
- Outline the basic structure and content of an EU Risk Management Plan and a Risk Evaluation and Mitigation Strategy
- Discuss primary tools for managing product risk and triggers for their modification or elimination
Target Audience:
This tutorial is designed for those in clinical safety and risk management, regulatory affairs, and post-authorization research, particularly those with responsibility for practical aspects of managing product risks in the context of the product's benefits.
1:30-5:00 pm Tutorial #4 (Half Day)
Optimization and Improving Operational Performance
Steve Jolley
Principal, SJ Pharma Consulting, Chairperson for Clinical
Safety and Pharmacovigilance SIAC
Ram Mohan, Phd
Management Consultant, Life Sciences
Centerline Partners LLP
Overview
This tutorial will describe how to assess and optimize pharmacovigilance operations from cost effective, compliance, and safety perspectives. A structured methodology for assessing drug safety operations will be presented. This will include
recognizing the need to conduct process analysis, developing and prioritizing
project portfolio, performing the analysis, and finally implementing the findings.
The methodology has helped companies increase compliance at reduced cost.
The scope covers all pharmacovigilance activities: case processing activities such
as case intake, data entry, assessment and reporting, and signaling activities such
as signal detection, evaluation and risk management.
Learning Objectives
At the conclusion of this tutorial, participants should be able to:
- Assess current pharmacovigilance environment – case processing and signaling
- Identify areas of improvements – redundancies, automating manual intensive operations, over/under inspections
- Implement metrics and organization change management, including critical success factors
- Identify obstacles to implementation
- Evaluate pros and cons of outsourcing/off-shoring
Target Audience
This tutorial is designed for those in clinical safety/pharmacovigilance, quality management, and clinical research & development.
Day 1 Monday, January 23, 2012
7:30-8:30 am Continental Breakfast and Attendee Registration
8:30-8:45 am Welcome and Opening Remarks
Program Chairperson
Mariette Boerstoel-Streefland, MD, MBA, MS(epi)
Chief Safety Officer, VP Global Drug Safety,
Forest Research Institute, Forest Laboratories Inc.
SiaC Chair
Steve Jolley
Principal, SJ Pharma Consulting; Chairperson for Clinical
Safety and Pharmacovigilance Special Interest Area Community (SIAC)
8:45-9:30 am Keynote Presentation
The Six Challenges and Opportunities of Safety Risk Management in a Global, Transparent, And Litigious World
Philippe Van der Auwera, MD, PhD
Global Head of Safety Risk Management
F. Hoffmann-La Roche Ltd., Switzerland
9:30-10:00 am Refreshment Break
10:00 am-12:00 pm Session 1
Regulatory Updates
Session Chairperson
Valerie E. Simmons, MD, FFPM
EU QPPV Executive, Global Patient Safety
Eli Lilly & Company Ltd., UK
10:00-11:00 am
EU Update
EMA Speaker Invited
11:00-11:30 am
US Update – New Safety Regulations
Gerald J. Dal Pan, MD, MHS
Director
Office of Surveillance and Epidemiology, CDER, FDA
11:30 am-12:00 pm
New IND Regulations
Mwango Kashoki, MD
Medical Officer
Office of New Drugs, CDER, FDA
12:00-1:00 pm Luncheon
1:00-3:15 pm Session 2
Regulatory Updates (Continued)
Session Chairperson
E. Stewart Geary MD
Vice President and Head of Global Pharmacovigilance
Eisai Co., Ltd.
1:00-1:30 pm
Japan Update
Junko Sato, PhD
Director for Risk Management, Office of Safety II
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
1:30-2:00 pm
Asia Pacific Update
E. Stewart Geary MD
Vice President and Head of Global Pharmacovigilance
Eisai Co., Ltd.
2:00-2:30 pm
Latin America Update
Marta C. V. Avellar
Pharmacovigilance Manager – Latin America
Global Pharmacovigilance and Risk Management
Shire
2:30-3:15 pm
Ask the Experts – Question and Answer Panel Discussion
3:15-3:45 pm Refreshment Break
3:45-5:15 pm Session 3
Social Media
Session Chairperson
Edwin J. Tucker, BSc, MB ChB, MRCP, MBA
VP, Head of PV Operations, Global Medical Safety
J&J Pharmaceutical Research & Development
3:45-4:30 pm
Social Media – Web-Based Media as an Opportunity to Create New
Insights Into Medicinal Products
Edwin J. Tucker, BSc, MB ChB, MRCP, MBA
VP, Head of PV Operations, Global Medical Safety
J&J Pharmaceutical Research & Development
4:30-5:15 pm
AE Reporting in the Era of Web 2.0: The Challenges of Having a Two-Way Conversation
Elizabeth E. Garrard, PharmD, RPh
Chief Safety Officer, Drug Safety Alliance
5:15-5:30 pm Day 1 Summary
5:30-6:30 pm Networking Reception
DAY 2 | Tuesday, January 24, 2012
7:30-8:30 am Registration and Continental Breakfast
8:30-10:00 am Session 4
Benefit Risk Optimization
Session Chairperson
William W. Gregory
Senior Director, Safety and Risk Management
Pfizer Inc.
8:30-9:00 AM
FDA Perspective: What Are We Learning from the Evaluation of REMS
Mary Willy, PhD
Deputy Director, Division of Risk Management
Office of Medication Error Prevention and Risk Management,
CDER, FDA
9:00-9:30 am
Tools: CIOMS IV, Value/Endpoints/Effectiveness
Meredith Y. Smith
Senior Scientific Director, Risk Management
Abbott Laboratories Global Pharmaceutical Research & Development
9:30-10:00 am
Integrated Evaluation of REMS/Risk Minimization
Swapu Banerjee, DM, MSc, MBA, MFPM, FRCP, FRCS,
FAcadMEd, FSB
Board Member and Head of Risk Management, Drug Safety& Regulatory, Pope Woodhead, UK
Faculty Member, Institute of Biotechnology, University of
Cambridge
10:00-10:30 am Refreshment Break
10:30 am-12:00 pm Session 5
Risk Management
Session Chairperson
Jean-Pierre Clement, MD
Vice President and Head of International
Pharmacovigilance
Global Medical Safety
Division of Johnson & Johnson Pharmaceutical R&D
10:30-11:00 am
EU Risk Management: What Changes Will the New PV
Legislation Bring?
Stella Blackburn
EMA Risk Management Development and Scientific Lead
European Medicines Agency, European Union
11:00-11:30 am
Post Authorization Safety Studies and The Impact on New EU PV
Legislation
Saad Shakir
Director
DSRU
11:30 am-12:00 pm
Patient's Like Me: Patient Perspective on Risk Management
James Heywood
Co-Founder, Chairman
Patient's Like Me
12:00-1:00 pm Luncheon
1:00-2:30 pm Session 6
Pharmcoepidemiology
Session Chairperson
Mariette Boerstoel-Streefland, MD, MBA, MS(epi)
Chief Safety Officer, Vice President Global Drug Safety, Forest Research Institute
Forest Laboratories Inc.
1:00-1:30 pm
Results on ENCePP (European Network of Centres for
Pharmacoepidemiology and Pharmacovigilance)
Stella Blackburn
EMA Risk Management Development and Scientific Lead
European Medicines Agency, European Union
1:30-2:00 pm
Results on Mini-sentinel
Marsha Reichman
Senior Advisor
Office of Surveillance and Epidemiology, CDER, FDA
2:00-2:30 pm
How FDA uses Epidemiology Data to Arise at Conclusions
Tarek A. Hammad, MD, PhD, MSc, MS
Deputy Division Director, Division of Epidemiology-I
CDER, FDA
2:30-3:00 pm Refreshment Break
3:00-4:30 pm Session 7
Do and Don'ts – Mock Deposition
Session Chairperson
Shinya Yamauchi
Operating Officer, Pharmacovigilance Department
Otsuka Pharmaceutical Co., Ltd., Japan
Product Liability, Historical Overview and Mock Deposition
3:00-4:30 pm
Product Liability, Historical Overview and
Mock Deposition
Richard F. Kingham, Esq
Partner
Covnington & Burling LLP
4:30-5:00 pm Day 2 Summary and Wrap Up
Day 3 Wednesday, January 25, 2012
7:30-8:30 am Registration and Continental Breakfast
8:30-10:00 am Session 8
Translating Pre-clinical Findings into Human Use
Session Chairperson
John Ayres, MD
Senior Medical Director
Eli Lilly, US
8:30-9:00 am
Weighing the Benefit Risk
Lewis B. Kinter, PhD
Senior Director, Regulatory Toxicology, Global Safety
Assessment
AstraZeneca Pharmaceuticals LP
9:00-9:30 am
Evaluation and Review of Study Protocols for Safety
and Risk
John Ayres, MD
Senior Medical Director
Eli Lilly, US
9:30-10:00 am
Ask the Experts – Question and Answer Panel Discussion
10:00-10:30 am Refreshment Break
10:30 am-12:00 pm Session 9
Development Safety Update Reports (DSUR)
Session Chairperson
Steve Jolley
Principal, SJ Pharma Consulting
Chairperson for Clinical
Safety and Pharmacovigilance SIAC
10:30-11:00 am
DSUR – EU Perspective
Barry Arnold, MBBCh, FRCA, FFPM
EU QPPV, Astra Zeneca, UK
11:00-11:30 am
DSUR – US Perspective
Ellis F. Unger
Deputy Director
Office of Drug Evaluation-I, Office of New Drugs, CDER, FDA
11:30 am-12:00 pm
Ask the Experts – Question and Answer
Panel Discussion
12:00-1:00 pm Luncheon
1:00-2:30 pm Session 10
What's Hot, What's Not
Session Chairperson
Stella Blackburn
EMA Risk Management Development and Scientific Lead
European Medicines Agency, European Union
1:00-1:30 pm
E2C[R2]: From PSUR to Benefit Risk Evaluation
Valerie E. Simmons, MD, FFPM [confirmed]
EU QPPV Executive, Global Patient Safety
Eli Lilly & Company Ltd., UK
1:30-2:00 pm
New from Japan
Hazuki Takaura, MS
Reviewer, Office of Safety ll, Pharmaceuticals and Medical
Devices Agency (PMDA), Japan
2:00-2:30 pm
Meta-Analyses of Clinical Data for Regulated Biopharmaceutical
Products
Speaker Invited
2:30-3:00 pm Meeting Wrap Up and Closing
3:00 pm Meeting Adjourns
Unless otherwise disclosed, DIA acknowledges that the statements made by speakers are their own opinion
and not necessarily that of the organization they represent, or that of the Drug Information Association.
Speakers and agenda are subject to change without notice.
Recording of any DIA tutorial/workshop information in any type of media, is prohibited without prior written consent from DIA.
Registration & Travel
Registration Fees
If DIA cannot verify your membership, you will be charged the nonmember fee. Registration fee includes refreshment breaks, luncheons, and reception (if applicable), and will be accepted by mail, fax, or online
| Member Early-bird Opportunity Available on nondiscount member fee only |
On or before Jan. 8, 2012 |
After Jan. 8, 2012 |
| Member Fee | US $1465 | US $1665 |
| Join DIA now to qualify for the early-bird member fee! | Membership | |
| US $140 | ||
| To qualify for the early-bird discount, registration form and accompanying payment must be received by the date above. Does not apply to government/academia/nonprofit members. | ||
| Nonmember Fee | US $1805 | |
| A one-year membership to DIA is available to those paying a nonmember registration fee. If paying a nonmember fee, please indicate if you do, or do not, want membership. | ||
| Discount Fees | Member | Non-Member |
| Government (Full-time) | US $665 | US $805 |
| Charitable Nonprofit/Academia (Full-time) | US $835 | US $975 |
Preconference Workshops, January 22. 2012 |
|
| #1 Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art, 8:30 AM-12:00 PM | US $405 |
| #2 Development Safety Update Reports (DSURs): Principles and Practicalities, 1:30-5:00 PM | US $405 |
| #3 Pharmacovigilance and Risk Management Planning, 8:30 AM-12:00 PM | US $405 |
| #4 Optimization and Improving Operational Performance, 1:30-5:00 PM | US $405 |
Group Discounts:
Register 3 individuals from the same company and receive complimentary registration for a 4th! All 4 individuals must register and prepay at the same time – no exceptions. 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. To take advantage of this offer, please download this registration form for EACH of the four registrants from your company. Include the names of all four group registrants on each of the forms and return them together to DIA.
Travel and Hotel
The most convenient airport is Ronald Reagan National Airport and attendees should make airline reservations as early as possible. The Sheraton National Hotel is holding a block of rooms at the reduced rate below until January 1, 2012, for the DIA event attendees. Room availability at this rate is guaranteed only until this date or until the block is filled.
Single $175 Double $175
Attendees must make their own hotel reservations. Contact the Sheraton National Hotel by telephone at +1.800.325.3535 and mention the DIA event. The hotel is located at 900 South Orme Street, Arlington, VA 22204, USA.
Cancellation Policy
On or before January 15, 2012
Administrative fee that will be withheld from refund amount:
Member or Nonmember = $200
Government or Academia or Nonprofit (Member or Nonmember) = $100
Tutorial (if applicable) = $50
Cancellations must be in writing and be received by the cancellation date above. Registrants who do not cancel by that date and do not attend will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. You may transfer your registration to a colleague at any time but membership is not transferable. Please notify DIA of any such substitutions as soon as possible. Substitute registrants will be responsible for nonmember fee, if applicable.
DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other costs incurred by registrants.
Participants with Disabilities
DIA event facilities and overnight accommodations are accessible to persons with disabilities. Services will be made available to sensory-impaired persons attending the event if requested at least 15 days prior to event. Contact the DIA office to indicate your needs.
Exhibit Information
Fee
Tabletop…………………$1,500.00
Tabletop Rental Fee includes:
- One (1) 6' skirted table;
- One (1) chair;
- Standard electricity
Each Tabletop rental requires at least one registered attendee to staff the table. All tabletop staff is required to register as an attendee for the conference.
Exhibits Show Date(s) & Location
January 23-25, 2012
Sheraton National Hotel
Arlington, VA, USA
Tabletop Exhibit Information
Attendees may visit the exhibits during the event and receptions.
Contact Jeff Korn, Exhibits Associate
Phone +1.215.442.6184,
Fax +1.215.442.6199, email Jeff.Korn@diahome.org
Useful Links
Tutorial Information
Tutorial #1 - Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art
Date & Time:
Sunday, Jan 22 2012 8:30AM - 12:00PM
Instructor(s):
Sally Van Doren, PharmD
President & Chief Executive Officer
BioSoteria, Inc., United States
Sheila Weiss Smith, PhD,MS,FISPE
Professor; Director, Center for Drug Safety
University of Maryland School of Pharmacy, United States
Tutorial #2 - Development Safety Update Reports (DSURs): Principles and Practicalities
Date & Time:
Sunday, Jan 22 2012 1:30PM - 5:00PM
Instructor(s):
Valerie E. Simmons, MD,FFPM
EU QPPV
Eli Lilly and Company Limited, United Kingdom
Barry Arnold, MD
EU Qualified Person for Pharmacovigilance
AstraZeneca, United Kingdom
Michael Richardson,
international Head GPV&E and EU QPPV
Bristol-Myers Squibb, United Kingdom
Tutorial #3 - Pharmacovigilance and Risk Management Planning
Date & Time:
Sunday, Jan 22 2012 8:30AM - 12:00PM
Instructor(s):
William W. Gregory, PhD
Senior Director, Safety and Risk Management
Pfizer Inc., United States
Robert Sharrar, MD
Executive Director, Safety, Epidemiology, Registries and Risk Management
United BioSource Corporation, United States
Tutorial #4 - Optimization and Improving Operational Performance
Date & Time:
Sunday, Jan 22 2012 1:30PM - 5:00PM
Instructor(s):
Steve Jolley, MA
Principal
SJ Pharma Consulting, United States
Ram Mohan, Phd
Management Consultant, Life Sciences
Centerline Partners LLP