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Quality Risk Management in Clinical Drug Development Workshop: Fundamentals and Practical Aspects

Dec 3 2012 8:15AM - Dec 4 2012 4:00PM | Sheraton Philadelphia Downtown Hotel 201 North 17th Street Philadelphia, PA 19103

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Overview 

Quality by Design and Quality Risk Management are fairly new concepts to the clinical trial environment, however those have become established in areas such as manufacturing, which are characterized by strong process dependency and precise quality specifications for deliverables. Quality Risk Management is a process for identifying quality-related hazards, estimating and evaluating the associated risks, controlling these risks, and monitoring the effectiveness of the control. This concept is now being applied to the clinical development process.  Quality Risk Management will help organizations to proactively identify, manage and mitigate risks to prevent and resolve compliance problems and to develop efficient and effective mitigation strategies.  The benefits include early detection of risks, providing a broader reach than traditional quality assurance and quality control methods can obtain and performing deeper insights with regards to quality risks and compliance around clinical development processes within an organization.  The core objectives for effective quality risk management will help to ensure patient safety and data integrity.

To date, the pharmaceutical industry has not generally applied QbD and QRM in clinical drug development, because clinical development activities are based on data-driven, iterative decision-making processes and involve complex multi-factorial internal and external influences, human experience and expert judgment.  However, a variety of stakeholders are now seeking to adapt the high-level principles of QbD and QRM to clinical development as a means of enhancing both quality and efficiency of development programs in a global environment.

Both EMA and FDA have been active in fostering these concepts.   Through the Clinical Trials Transformation Initiative, a public-private partnership, FDA has been engaged in a Quality by Design (QbD) project that emphasizes building quality into the scientific and operational design of a trial, rather than attempting to “test” quality in retrospectively.

This two-day introductory workshop will provide attendees with the essential information and practical skills needed to build a strong foundation for identifying and managing important risks to quality in the clinical drug development process.

DIA plans a follow-up workshop going into more details that will be held in Spring 2013 and will be a more advanced-level application of applying some of these tools and concepts.

Featured Topics 

  • QRM: A Regulatory and Business Perspective
  • Practical Aspects of Implementing a Risk-based Approach in Clinical Drug Development
  • Future Requirements – How to Implement the Current Guidelines into Practice?
  • Current Initiatives and Updates on CTTI
  • Workshop Activity – How Do you Identify Risk and Apply QbD?

Who Should Attend 

Professionals from Academia, Pharmaceutical/Biotech Industry, Investigational Sites and Biopharmaceutical Service Providers involved in:

  • Quality Risk Management
  • Quality Assurance/Clinical Compliance
  • Clinical Development/Clinical Operations
  • Clinical Trial Management
  • Pharmacovigilance and Safety
  • Regulatory Affairs
  • Biostatistics
  • Clinical Project Management
  • Trial Conduct/Site Coordination
  • Data Management
  • Vendor Oversight/Management

Learning Objectives 

At the end of the two-day workshop participants will

  • Describe the principles of QbD and QRM and how they may be applied to clinical trials, safety reporting and/or clinical development programs
  • Discuss industry trends and current regulatory guidance regarding a risk-based approach to managing clinical trials
  • Examine different approaches to QbD and QRM from a diverse community of industry, academia, investigational sites and service providers

Special Offers 

Group Discounts Available! 
Register 3 and Get the 4th FREE!

 

Hotel & Travel 

Sheraton Philadelphia Downtown Hotel
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until November 10, 2012, or until room block is filled). Attendees must make their own hotel reservations.

Standard Room Rate $149

Address: 201 North 17th Street, Philadelphia, PA 19103
Phone: +1.215.448.2000 or 1.800.325.3535

The most convenient airport is Philadelphia International and attendees should make both airline and hotel reservations as early as possible.

Contact Information 

Registration Questions
Marilyn Ginsberg, Customer Service Associate
Phone +1.215.442.6135
Fax +1.215.442.6199
Marilyn.Ginsberg@diahome.org

Agenda and Event Details
Rachel Minnick, Content Lead
Phone +1.215.442.6131
Fax +1-215.442.6199
Rachel.Minnick@diahome.org

JoAnn Boileau, Event Planner
Phone +1.215.442.6175
Fax +1.215.442.6199
JoAnn.Boileau@diahome.org

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

Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to 12.5 contact hours or 1.25 CEUs. Day 1: Type of Activity: Knowledge UAN: 0286-0000-12-099-L04-P Day 2: Type of Activity: Application UAN: 0286-0000-12-100-L04-P


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

Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102.

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer 1.3 CEUs 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.

CERTIFICATE PROGRAM
This program is part of DIA’s Certificate Program and is awarded the following.
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units each

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

Name Credit Type Max Credits CEU
Quality Risk Management in Clinical Drug Developmn ACPE 12.50 1.250
Quality Risk Management in Clinical Drug Developmn IACET 12.50 1.300

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 program, 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 Tuesday, December 18.

To view DIA’s Grievance Policy, please visit the CE page on DIA’s website at www.diahome.org

Program Committee 

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Agenda  

Day 1 Monday, December 03, 2012

  • 8:15AM - 8:30AM

    Welcome and Opening Remarks

    Speaker(s):

    • Peter Schiemann, PhD
      Managing Partner
      Widler & Schiemann Ltd, Switzerland
  • 8:30AM - 9:30AM

    Session 1 – QRM: A Regulatory and Business Perspective


    Session Chair(s):

    • Peter Schiemann, PhD
      Managing Partner
      Widler & Schiemann Ltd, Switzerland

    This session will explore QRM from both a regulatory and business perspective. In the first talk, FDA will share current initiatives for establishing QRM guidelines. In the second talk, the business case for using QRM in the clinical process will be presented.

    Speaker(s):

    • Session 6 – Current Initiatives and Updates on CTTI
      Peter Schiemann, PhD
      Managing Partner
      Widler & Schiemann Ltd, Switzerland
    • The Clinical Trial Enterprise: Defining Quality
      Jean Mulinde, MD
      Sr. Advisor, Div of GCP Compliance, Office of Scientific Investigations, CDER
      FDA, United States
    • Case for Change - Business Case for QRM
      Kenneth D. Schiff, MBA
      President
      Quality Risk Management Associates, LLC, United States
  • 10:00AM - 12:00PM

    Session 2 - Practical Aspects of Implementing a Risk-based Approach in Clinical Drug Development


    Session Chair(s):

    • Kenneth D. Schiff, MBA
      President
      Quality Risk Management Associates, LLC, United States
    • Kenneth J. Sprenger, MD
      Executive Director, Medicine Team Leader
      Pfizer Inc, United States

    This session will provide a look at practical aspects of implementing QbD into the clinical development process by focusing on designing protocols, study set up, site monitoring and safety reporting.

    Speaker(s):

    • Designing Protocols
      Kenneth J. Sprenger, MD
      Executive Director, Medicine Team Leader
      Pfizer Inc, United States
    • Study Set-up
      Peter Schiemann, PhD
      Managing Partner
      Widler & Schiemann Ltd, Switzerland
    • Conducting Clinical Trials/Site Monitoring
      Brian J. Nugent, PhD
      Associate Director, Clinical Operations
      Gilead Sciences, Inc., United States
    • Pro-active Safety Risk Management
      Barbara Leishman, MA
      External Business Alliance Leader
      F. Hoffmann-La Roche Ltd., Switzerland
  • 1:00PM - 3:00PM

    Session 3 - Practical Aspects of Implementing a Risk-based Approach in Clinical Drug Development (continued)


    Session Chair(s):

    • Kenneth D. Schiff, MBA
      President
      Quality Risk Management Associates, LLC, United States
    • Kenneth J. Sprenger, MD
      Executive Director, Medicine Team Leader
      Pfizer Inc, United States

    This session will continue the discussion of implementing a risk-based approach in the clinical development process by focusing on risk assessment and reporting. Speakers will address the practical aspects of data management, risk-based monitoring and trial oversight.

    Speaker(s):

    • Ensuring Regulatory Compliance: Is QRM The Answer?
      Jean Mulinde, MD
      Sr. Advisor, Div of GCP Compliance, Office of Scientific Investigations, CDER
      FDA, United States
    • Ensuring Regulatory Compliance: Is QRM The Answer?
      Ann Meeker-O'Connell, MS
      Director, Division of GCP Compliance (Acting), OSI, Office of Compliance, CDER
      FDA, United States
    • Investigative Sites
      Sina Djali, MSc
      Director, Quality Monitoring and Compliance
      Janssen Family of Pharmaceuticals, United States
    • Trial Oversight
      David F. Nickerson, PMP
      Senior Director
      Pfizer Inc, United States
    • Implementation of Methodology and Tools to Make it Happen - Implementing a QRM System: A Report from the Front
      Randy Ramin-Wright, MS
      QRM Consultant / QRM Business Unit Manager
      International Institute for the Safety of Medicine, Switzerland
  • 3:30PM - 5:00PM

    Session 4 - Practical Aspects of Implementing a Risk-based Approach in Clinical Drug Development – Case Studies


    Session Chair(s):

    • Briggs W. Morrison, MD
      Head, Global Medicines Department
      AstraZeneca, United States

    This session will conclude the discussion of implementing a risk-based approach in the clinical drug development process by presenting case studies and hands-on experience from the Pharma, CRO and Investigative Site perspective.

    Speaker(s):

    • Pharma Perspective
      Carol A. McKenna, RN
      Director, Clinical Trial Excellence and Analytics/Quality Risk Management
      Biogen Idec, United States
    • CRO Perspective
      Heide Sterckx
      Associate Director Quality Risk Management, GQ&C
      PPD, United States
    • Academic Perspective
      David A. Schoenfeld, PhD
      Professor of Medicine, Professor Dept of Biostatistics, Harvard Sch Pub Health
      Massachusetts General Hosp, Harvard Medical School, United States

Day 2 Tuesday, December 04, 2012

  • 8:30AM - 10:00AM

    Session 5 - Panel Discussion - Future Requirements – How to Implement the Current Guidelines into Practice?


    Session Chair(s):

    • Briggs W. Morrison, MD
      Head, Global Medicines Department
      AstraZeneca, United States

    This panel discussion, featuring regulatory speakers from FDA and EMA, will address implementation of the current QRM guidelines and what to expect for future requirements.

    Speaker(s):

    • Panelist
      Ann Meeker-O'Connell, MS
      Director, Division of GCP Compliance (Acting), OSI, Office of Compliance, CDER
      FDA, United States
    • Panelist
      Noemi Manent
      Scientific Administrator, Compliance and Inspection
      European Medicines Agency, European Union , United Kingdom
    • Panelist
      Rehbar H. Tayyabkhan
      Executive Director, GDO Business Operations and RCO Latin America
      Bristol-Myers Squibb Company, United States
    • Panelist
      John H. Alexander, MD
      Associate Professor of Medicine, Division of Cardiology, Duke University Med Ctr
      Duke Clinical Research Institute - Duke University, United States
  • 10:30AM - 12:00PM

    Session 6 – Current Initiatives and Updates on CTTI


    Session Chair(s):

    • Peter Schiemann, PhD
      Managing Partner
      Widler & Schiemann Ltd, Switzerland

    This session will include a high-level summary of the CTTI workshop that was held in September 2012. The speakers will share the CTTI principles document and overview of the current CTTI initiatives.

    Speaker(s):

    • Speaker
      Ann Meeker-O'Connell, MS
      Director, Division of GCP Compliance (Acting), OSI, Office of Compliance, CDER
      FDA, United States
    • Speaker
      Briggs W. Morrison, MD
      Head, Global Medicines Department
      AstraZeneca, United States
  • 1:00PM - 3:00PM

    Session 7 – Workshop Activity – How Do you Identify Risk and Apply QbD?


    Session Chair(s):

    • Briggs W. Morrison, MD
      Head, Global Medicines Department
      AstraZeneca, United States
    • Peter Schiemann, PhD
      Managing Partner
      Widler & Schiemann Ltd, Switzerland
    • Kenneth D. Schiff, MBA
      President
      Quality Risk Management Associates, LLC, United States

    Participants will break into small groups and complete a case study. This hands-on activity will encourage attendees to engage with their colleagues to discuss identifying risk and applying QbD principles.

  • 3:15PM - 4:00PM

    Session 8 – Wrap Up/Report Out and Closing Remarks


    Session Chair(s):

    • Peter Schiemann, PhD
      Managing Partner
      Widler & Schiemann Ltd, Switzerland

    Each breakout group will present a brief summary of their workshop activity discussion.

Exhibits  

The Quality Risk Management in Clinical Drug Development Workshop, co-located with the Strategic Planning and Partnering in Global Clinical Trials 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
December 3-4, 2012

Useful Links

  • ii4sm - International Institute for the Safety of Medicines

Registration Fees 

Member

Member Academia
$745.00
Member Government
$595.00
Member Standard
$1490.00

Non-Member

NonMember Academia
$920.00
NonMember Government
$770.00
NonMember Standard
$1665.00
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. To take advantage of this offer, click on “View PDF” below and make four copies of the registration form.  Complete the main registration for each of the four registrants and include the names of all other group registrants in the Group Discount section. DIA will apply the value of the lowest applicable fee to this complimentary registration; it does NOT include fees for optional events or DIA membership. You may substitute group participants of the same membership status at any time; however, administrative fees may be incurred.

Group registration is not available online and does not apply to the already-discounted fees for government or charitable nonprofit/academia.

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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