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Pharmacovigilance and Risk Management Strategies 2015

Jan 26 2015 8:30AM - Jan 28 2015 4:00PM | Renaissance Washington DC Downtown Hotel 999 Ninth Street NW Washington, DC 20001

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Overview 

Tutorials: January 25, 2015

Tutorial 1:
Pharmacovigilance and Risk Management Planning
Tutorial 2: Introduction to Pharmacoepidemiology and Applications in Premarketing and Postmarketing Surveillance, Risk Management and Value Demonstration
Tutorial 3: PBRERs
Tutorial 4: Pharmacovigilance System Master File


Benefit-Risk in 2015! Regulatory science, tools, realities, and perceptions of biopharmaceutical product benefit-risk continue to evolve across the global pharmacovigilance landscape. During this three-day meeting, thought leaders from around the world will provide their insight and engage in dialogue on current opportunities and challenges in managing product risk in the context of benefit. The current regulatory framework will be outlined and practical approaches to protecting patient safety will be discussed.

This event will provide a unique setting for informal dialogue with representatives from FDA and other key regulatory agencies, as well as from industry and academia. There will be multiple opportunities for participants to engage speakers and interact with fellow colleagues.


Meeting Highlights

  • Keynote Presentation by Professor Stephen Evans of the London School of Hygiene & Tropical Medicine
  • Luncheon Roundtable Discussions
  • Tabletop Exhibits
  • Pre-meeting Tutorial Offerings

Who Should Attend 

Professionals with intermediate to advanced knowledge of, and experience in, clinical safety and who are involved in:

  • Pharmacovigilance
  • Drug safety
  • Risk management
  • Medical product safety assessment
  • Regulatory affairs
  • Clinical research
  • Data analysis
  • Pharmacoepidemiology
  • Medical information
  • Health outcomes

It is also designed for professionals who work for:

  • Industry: pharmaceuticals and biologics
  • Clinical Research Organizations
  • Academic Research Centers
  • Regulatory Agencies

Learning Objectives 

At the conclusion of this meeting, attendees will be able to:

  • Describe the current regulatory framework for pharmacovigilance in key markets
  • Discuss global implications of the Pharmacovigilance System Master File
  • Explain basic risk minimization interventions, measures of their effectiveness, and integration into selected health care systems
  • Describe new approaches for safety assessment of biosimilars in early clinical development
  • Examine the role of Real World Evidence in assessing product risk in the context of benefit
  • Discuss the impact of health literacy on risk communication

Special Offers 

Early Bird Registration
Industry Members save $200
Register by January 5, 2015

Group Discount Available!
Register 3 and Get the 4th Free!

Hotel & Travel 

Renaissance Washington DC Downtown Hotel
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until January 9, 2015, or until room block is filled).  Please note: In order to receive the reduced room rate, hotel reservations must be made with Travel Planners and not directly with the hotel.  Contact information for Travel Planners: Attendees can follow this link to make reservations online or call toll free in the US 1.855.355.0302 or +1.212.532.1660. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #15002.

Standard Room Rate $195

Hotel Address: 999 Ninth Street NW Washington, DC 20001 USA

PLEASE READ
Warning:
Unauthorized Solicitation

The most convenient airport is Ronald Reagan Washington National Airport or Washington Dulles International Airport - attendees should make both airline and hotel reservations as early as possible.

 

Contact Information 

Printable Registration Form

Registration Questions
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Agenda Details
Rachel Minnick, Content Lead
Phone +1.215.442.6131
Fax +1.215.442.6199
Rachel.Minnick@diahome.org

Event Logistics
Ellen Diegel, Event Planner
Phone +1.215.293.5810
Fax +1.215.442.6199
Ellen.Diegel@diahome.org

Tabletop Exhibit
Jeff Korn, Exhibits Associate
Phone +1.215.442.6184
Fax +1.215.442.6199
Jeff.Korn@diahome.org

Continuing Education 

00000000

This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Postgraduate Institute for Medicine (PIM) and DIA. PIM is accredited by the ACCME to provide continuing medical education for physicians.

PIM designates this live activity for a maximum of 16.5 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

DIA is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. DIA designates this educational activity for up to 11.75 contact hours or 1.175 continuing education units (CEUs).
Type of Activity: Knowledge

ACPE Credit Request – UPDATE
DIA 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 DIA’s 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 www.cpemonitor.net. ALL ACPE CREDIT REQUESTS MUST BE SUBMITTED BY FRIDAY, MARCH 13, 2015.

Corexcel is accredited as a provider of continuing nursing education by American Nurses Credentialing Center’s Commission on Accreditation.

Corexcel designates this activity for a maximum of 23.0 contact hours.

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 2.3 CEUs (.3 CEUs for half day tutorials; .6 CEUs for full day tutorial: 1.7 CEUs for the meeting) for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

DIA’s Certificate Program Statement
This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 12 Elective Units • Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
• Regulatory Affairs Certificate Program: 12 Elective Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Tutorial #4 – Pharmacovigilance System Master File IACET 3.25 0.300
Tutorial #4 – Pharmacovigilance System Master File RN 3.25 0.000
Tutorial #3 – PBRERs IACET 3.25 0.300
Tutorial #3 – PBRERs RN 3.25 0.000
Tutorial #2 - Introduction to Pharmacoepidemiology IACET 3.25 0.300
Tutorial #2 - Introduction to Pharmacoepidemiology RN 3.25 0.000
Tutorial #1 - Pharmacovigilance and Risk Managemen ACPE 6.00 0.600
Tutorial #1 - Pharmacovigilance and Risk Managemen IACET 6.00 0.600
Tutorial #1 - Pharmacovigilance and Risk Managemen RN 6.00 0.000
Pharmacovigilance and Risk Management Strategies IACET 16.50 1.700
Pharmacovigilance and Risk Management Strategies RN 16.50 0.000
Pharmacovigilance and Risk Management Strategies ACPE 11.75 1.175
Pharmacovigilance and Risk Management Strategies CME 16.50 0.000

Disclosure Policy:

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 and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must attend the program and tutorial(s), if applicable, sign-in at the DIA registration desk each day of the meeting, and complete the on-line credit request process through DIA’s My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” 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, February 11, 2015.

To view DIA’s grievance policy, please visit the CE page on the DIA website at www.diahome.org/CE

Program Committee 

Previous Next

Agenda  

Tutorials Sunday, Jan 25, 2015

  • 10:00AM - 5:00PM

    Pharmacovigilance and Risk Management Planning

    This tutorial will be presented in two parts. Part 1 (10:00 AM – 12:00 PM) will focus on basic aspects of the regulatory framework for pharmacovigilance in the context of risk management planning. Part 2 (12:45 PM – 5:00 PM) will focus on the practical aspects of managing biopharmaceutical product risks in the context of benefits and the healthcare delivery system.

    A box lunch will be served from 12:00 - 12:45 PM

  • 8:30AM - 12:00PM

    Introduction to Pharmacoepidemiology and Applications in Premarketing and Postmarketing Surveillance, Risk Management and Value Demonstration

    This tutorial will provide an overview of basic epidemiology methods and study designs as they are applied in the pharmaceutical and biotechnology industries. Topics will include design and conduct of retrospective and prospective epidemiologic studies such as case-control studies and cohort studies, and the application of these designs for premarketing and postmarketing surveillance, risk management (risk assessment and risk mitigation), and demonstration of product value.

    Lunch is not provided for half-day tutorial attendees.

  • 1:30PM - 5:00PM

    PBRERs

    The new ICH E2C (E2C) guideline on Periodic Benefit-Risk Evaluation Reports (PBRERs) reached Step 4 in November 2012 and has already implemented in the EU under the new Pharmacovigilance legislation. Also
    accepted in the US, Japan, and other countries, the PBRER may replace existing requirements for postmarketing periodic reporting. This new report represents a significant change from the previous PSUR format and a quantum leap forward towards a document incorporating many new concepts including an integrated evaluation of both benefits and risks of a medicinal product.

    Lunch is not provided for half-day tutorial attendees.

  • 1:30PM - 5:00PM

    Pharmacovigilance System Master File

    As part of the new EU Pharmacovigilance Legislation (Regulation EU 1235/2010 and Directive 2010/84/EU) marketing-authorization holders are required to maintain a Pharmacovigilance System Master File (PSMF). The PSMF must be in place at the time of initial marketing authorization application, license renewal and available for inspections. The PSMF replaced the Detailed Description of the Pharmacovigilance System (DDPS). This tutorial will cover the requirements in the PSMF, the creation and maintenance as well as sharing a real experience focusing on some of challenges and how they can be addressed.

    Lunch is not provided for half-day tutorial attendees.

Day 1 Monday, Jan 26, 2015

  • 7:30AM - 8:30AM

    Continental Breakfast and Attendee Registration
  • 8:30AM - 8:45AM

    Welcome and Opening Remarks

    Speaker(s):

    • William W. Gregory, PhD
      Senior Director, Worldwide Safety and Regulatory
      Pfizer Inc, United States
    • Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
      Vice President, Global Head of Risk Management
      Quintiles., United Kingdom
  • 8:45AM - 10:00AM

    Session 1 - Keynote Presentation


    Session Chair(s):

    • William W. Gregory, PhD
      Senior Director, Worldwide Safety and Regulatory
      Pfizer Inc, United States
    • Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
      Vice President, Global Head of Risk Management
      Quintiles., United Kingdom

    Speaker(s):

    • Do Systematic Analyses of Safety Data Have Adverse Effects?
      Stephen JW Evans, MSc, FRCP
      Professor of Pharmacoepidemiology
      The London School of Hygiene & Tropical Medicine, United Kingdom
  • 10:00AM - 10:30AM

    Refreshment Break
  • 10:30AM - 12:00PM

    Session 2 – FDA Updates


    Session Chair(s):

    • FDA Session Chair Invited
      United States

    Speaker(s):

    • Additional FDA Speakers Invited
      United States
  • 12:00PM - 1:30PM

    Roundtable Lunch Discussions
  • 1:30PM - 3:00PM

    Session 3 – Asia Regulatory Updates


    Session Chair(s):

    • No-image Stewart Geary, MD
      Senior Vice President, Chief Medical Officer
      Eisai Co., Ltd., Japan

    Speaker(s):

    • Japanese Perspective (new pharmaceutical affairs law)
      Daisaku Sato, PhD
      Director, Office of Cellular and Tissue-based Products
      Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    • Korea Perspective
      Nam-Kyong Choi, PhD
      Research Professor, Division of Clinical Epidemiology
      Seoul National University College of Medicine, Korea, Republic of
    • China Perspective
      Speaker Invited
      United States
  • 3:00PM - 3:30PM

    Refreshment Break
  • 3:30PM - 5:00PM

    Session 4 – Maturing Markets Perspective


    Session Chair(s):

    • William W. Gregory, PhD
      Senior Director, Worldwide Safety and Regulatory
      Pfizer Inc, United States

    Speaker(s):

    • India Perspective
      Speaker Invited
      United States
    • Brazil Perspective
      Speaker Invited
      United States
    • Eastern Europe/Turkey
      Michelle Bulliard, BSN
      VP
      Quintiles, Switzerland
    • Industry perspective
      Speaker Invited
      United States
  • 5:00PM - 6:00PM

    Networking Reception

Day 2 Tuesday, Jan 27, 2015

  • 7:30AM - 8:30AM

    Continental Breakfast and Attendee Registration
  • 8:30AM - 10:00AM

    Session 5 – EU Regulatory Updates


    Session Chair(s):

    • Michael Richardson, MD, FFPM
      International Head GPV&E and EU QPPV
      Bristol-Myers Squibb, United Kingdom

    Speaker(s):

    • A Very Personal Perspective on PRAC (Pharmacovigilance and Risk Committee)
      Stephen JW Evans, MSc, FRCP
      Professor of Pharmacoepidemiology
      The London School of Hygiene & Tropical Medicine, United Kingdom
    • Success and Future Challenges of New Regulations
      Mick Foy
      Group Manager, Vigilance Intelligence and Research Group
      MHRA, United Kingdom
    • Success and Future Challenges of New Regulations – Industry Perspective
      Vicki Edwards
      QPPV and Head of Affiliate Vigilance Excellence
      Abbvie Ltd., United Kingdom
  • 10:00AM - 10:30AM

    Refreshment Break
  • 10:30AM - 12:00PM

    Session 6 - Regional Requirements with Global Impact: The Drivers for Change


    Session Chair(s):

    • Justina A. Molzon, JD, MSc, RPh
      Retired, United States
    • Michael Richardson, MD, FFPM
      International Head GPV&E and EU QPPV
      Bristol-Myers Squibb, United Kingdom

    Speaker(s):

    • FDA Perspective of Maturing Agencies & Legislation
      FDA Speaker Invited
      United States
    • Pharmacovigilance System Master File
      Noha Kassem, PhD
      Senior Director of Quality in Global Patient Safety
      Eli Lilly & Company Ltd., United Kingdom
    • A View of APEC
      Speaker Invited
      United States
    • Global Database and Accommodating Differing Reporting Requirements and Safety Analysis
      Eileen Leonard, PharmD
      Executive Director, GPV&E
      Bristol-Myers Squibb Company, United States
  • 12:00PM - 1:30PM

    Lunch
  • 1:30PM - 3:00PM

    Session 7 – Risk Management Planning


    Session Chair(s):

    • Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
      Vice President, Global Head of Risk Management
      Quintiles., United Kingdom

    Speaker(s):

    • Moving from Risk Management to Benefit Risk Management
      Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
      Vice President, Global Head of Risk Management
      Quintiles., United Kingdom
    • Challenges and Tips for Managing a Global RMP
      Valerie E. Simmons, MD, FFPM
      EU QPPV, Executive, Global Patient Safety
      Eli Lilly and Company Ltd, United Kingdom
    • Different Strategies for Risk Minimization in the EU
      Panos Tsintis, DrMed, FFPM, FRCP
      Medical Advisor & Advisory Board Member
      NDA Group, United Kingdom
  • 3:00PM - 3:30PM

    Refreshment Break
  • 3:30PM - 5:00PM

    Session 8 – Implementing Additional Risk Minimization Tools and Measuring Their Effectiveness


    Session Chair(s):

    • William W. Gregory, PhD
      Senior Director, Worldwide Safety and Regulatory
      Pfizer Inc, United States
    • Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP
      Vice President, Global Head of Risk Management
      Quintiles., United Kingdom

    Speaker(s):

    • Risk Minimization – Tools to Measure Effectiveness
      FDA Speaker Invited
      United States
    • Case Study
      Michael Richardson, MD, FFPM
      International Head GPV&E and EU QPPV
      Bristol-Myers Squibb, United Kingdom
    • Future Direction: CIOMS IX
      William W. Gregory, PhD
      Senior Director, Worldwide Safety and Regulatory
      Pfizer Inc, United States

Day 3 Wednesday, Jan 28, 2015

  • 7:30AM - 8:30AM

    Continental Breakfast and Attendee Registration
  • 8:30AM - 10:00AM

    Session 9 - Enhancing Pharmacovigilance Engagement in Early Stage Clinical Development of Large Molecules


    Session Chair(s):

    • Stephen Knowles, MD, MRCP
      Senior Director, Global Patient Safety
      Eli Lilly and Company, United States

    Speaker(s):

    • Toxicology - Looking to the Future of “Organ on a Chip” Preliminary Work Before Going Into Animals
      Speaker Invited
      United States
    • Biosimilars
      Jan Hillson
      Senior Director of Clinical and Translational Research
      Momenta Pharmaceuticals, Inc., United States
    • Regulator Perspective
      Thomas Felix, MD
      Director, Research and Development Policy
      Amgen Inc., United States
  • 10:00AM - 10:30AM

    Refreshment Break
  • 10:30AM - 12:00PM

    Session 10 – Real World Evidence – A True Snapshot of Benefit and Risk


    Session Chair(s):

    • Mariette Boerstoel-Streefland, MD, MBA, MS
      Head, Global Safety and Pharmacovigilance
      Baxter International Inc. , United States

    Speaker(s):

    • Exploring New Methods for Pharmacovigilance
      Nancy A. Dreyer, PhD, MPH, FISPE
      Global Chief of Scientific Affairs, Real-World and Late Phase Research
      Quintiles Realworld & Late Phase Research, United States
    • Andres Gomez
      Head of Epidemiology, Signal Detection and Data Management
      Bristol Myers Squibb, United States
    • Benefits and Harms of "Real World" Evidence: Should We Be Changing Our Views?
      Stephen JW Evans, MSc, FRCP
      Professor of Pharmacoepidemiology
      The London School of Hygiene & Tropical Medicine, United Kingdom
  • 12:00PM - 1:30PM

    Lunch
  • 1:30PM - 3:00PM

    Session 11 - Stakeholder Perspectives on Communicating Risk


    Session Chair(s):

    • Stephen Knowles, MD, MRCP
      Senior Director, Global Patient Safety
      Eli Lilly and Company, United States

    Speaker(s):

    • MHRA Perspective
      Mick Foy
      Group Manager, Vigilance Intelligence and Research Group
      MHRA, United Kingdom
    • Risk Communication and Health Literacy in Healthcare Systems
      Michael S. Wolf
      Professor, Medicine-General Internal Medicine & Geriatrics
      Northwestern University Feinberg School of Medicine, United States
    • Patient Perspective
      Toni Cordell
      Consultant
      Toni Cordell, United States
  • 3:00PM - 3:00PM

    Conference Adjourns

Exhibits  

The Pharmacovigilance and Risk Management Strategies 2015 meeting offers interested companies the opportunity to exhibit with a tabletop display.

Tabletop Fee: $1,500

Fee Includes:

  • One six-foot skirted table
  • One chair
  • Standard electricity

Each tabletop rental requires at least one registered attendee to staff the table. All tabletop staff must be registered conference attendees.

Tabletop Exhibit Dates
January 26-28, 2015

Useful Links

  • APCER Pharma Solutions, Inc.
  • DIA
  • Drug Safety Alliance | Ashfield Pharmacovigilance
  • Foresight Group International, AG
  • Medical Vigilance Solutions (MVS)
  • November Research Group
  • Online Business Applications
  • Oviya MedSafe
  • PPD
  • PROSAR
  • Quintiles
  • Regeneron Pharmaceuticals
  • RxLogix Corporation
  • SafetyCall International, PLLC
  • Sciformix Corporation
  • Telerx
  • the Uppsala Monitoring Centre
  • Vigilare International

Registration Fees 

Member

Charitable Nonprofit/Academia Member
$895.00
Member Government
$715.00
Member Industry
$1585.00
Member Industry (As of 01/06/2015)
$1785.00

Non-Member

Charitable Nonprofit/Academia Nonmember
$1120.00
NonMember Government
$940.00
NonMember Industry
$2010.00
Registration Fees for Additional Offerings
Tutorial #1 - Pharmacovigilance and Risk Management Planning - Tutorial Rate
$755.00
Tutorial #2 - Introduction to Pharmacoepidemiology - Tutorial Rate
$405.00
Tutorial #3 – PBRERs - Tutorial Rate
$405.00
Tutorial #4 – Pharmacovigilance System Master File - Tutorial Rate
$405.00
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. 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 print a 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.

Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. 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.

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