DIA
Drug Information Association Logo

Global Labeling 2014: Compliance in a Changing Regulatory Environment

Apr 9 2014 7:00AM - Apr 10 2014 5:45PM | Bethesda North Marriott Hotel and Conference Center 5701 Marinelli Road, North Bethesda, MD 20852 USA

« Back to Listing

Overview 

Tutorial:  April 8, 2014



Regulators and industry representatives will discuss the impact of recent labeling guidelines and regulations including:

  • EU global pharmacovigilance guidelines
  • Draft and new FDA guidances
  • Plain language initiative in Canada
  • Risk management regulations in Japan
  • Other emerging labeling guidances (Canada, European Union, Japan, US)

This will provide information to assist in:

  • Labeling content decision making (core and local)
  • Local labeling implementation and tracking
  • Managing labeling system performance
  • Designing the interface between signal management and labeling process
  • Regional labeling coordination in Asia 


This program has been developed by the Regulatory Affairs Community-Labeling Working Group

Who Should Attend 

  • Clinical Safety/Pharmacovigilance
  • Labeling
  • Regulatory Affairs
  • Advertising and Promotion
  • Clinical Research
  • Medical Writing
  • Medical Communications
  • Product Research and Development
  • Quality Assurance / Quality Control
  • Public Policy/Law/Corporate Compliance

Learning Objectives 

At the conclusion of this meeting, participants should be able to:

  • Discuss the potential impact of the EU GVP guidelines on core labeling implementation
  • Describe regulatory expectations for tracking the implementation of core safety information into local labeling
  • Explain the complexity of tracking labeling changes and recognize how to use this information to manage labeling system performance
  • Identify how to align  core safety labeling decision making with signal management under the EU GVP guidelines
  • Describe how to manage and document the performance of a global labeling system
  • Discuss the scope of pharmacovigilance system self-audits and their impact on global labeling activities and review by regulatory agencies
  • Identify models for regional labeling coordination in Asia
  • Discuss methods for reducing medication errors
  • Explain new labeling-related developments in Canada, EU, Japan, and USA

Special Offers 

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

Hotel & Travel 

The conference will be held at the Bethesda North Marriott Hotel and Conference Center. 
A limited number of rooms are available at the reduced rate shown below (DIA rate is guaranteed until Monday March 24, 2014, or until room block is filled). Please Note: In order to receive the reduced room rate, hotel reservations must be made through Travel Planners, and not directly with the hotel.  Attendees can follow this link or make their hotel reservations with Travel Planners by calling +1.212.532.1660 or in the USA at 1.800.221.3531. When calling please select option 1 for “Hotel Reservations,” inform the phone agent that you are making a reservation for Event #14022. 

Standard Room Rate $226
Rate includes complimentary internet for all guest rooms booked using Travel Planners information noted above.

Hotel Address: 5701 Marinelli Road North Bethesda, MD 20852

PLEASE READ
Warning: Unauthorized Solicitation

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

Contact Information 

Registration Questions
Customer Service Department
Toll Free: 1.888.257.6457
Phone: +1.215.442.6100
Fax: +1.215.442.6199
CustomerService@diahome.org

Agenda Details
Melissa Buchanan, Content Lead
Phone +1.215.442.6158
Fax +1.215.442.6199
Melissa.Buchanan@diahome.org

Event Logistics
Benjamin Zaitz, Event Planner
Phone +1.215.293.5803
Fax +1.215.442.6199
Benjamin.Zaitz@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. This program is designated for up to 3.5 contact hours or .35 continuing education units (CEU’s).

Type of Activity: Knowledge

ACPE Credit Request
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; +1.703.506.3275.

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 1.9 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.

This program is part of DIA’s Certificate Program and is awarded the following:
• Clinical Research Certificate Program: 8 Elective Units
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
• Regulatory Affairs Certificate Program: 8 Elective Units

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

Name Credit Type Max Credits CEU
Tutorial 1 IACET 6.00 0.600
Global Labeling 2014: Compliance in a Changing Reg ACPE 3.50 0.350
Global Labeling 2014: Compliance in a Changing Reg IACET 13.00 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, if applicable, sign in at the DIA registration desk each day of the program, and complete the online credit request process through My Transcript. 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 Thursday, April 24, 2014.

Continuing Education Credit Allocation

Tutorial: IACET .6 CEUs

Meeting: IACET 1.3 CEUs
Meeting Pharmacy:
Session 3: Tracking from Signal to Package: 1.5 contact hours or .15 CEUs; 0286-0000-14-043-L04-P
Session 9: FDA Labeling Update: 2 contact hours or .2 CEUs; 0286-0000-14-044-L04-P

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

Program Committee 

Previous Next

Agenda  

Tutorials Tuesday, Apr 08, 2014

  • 8:00AM - 4:00PM

    Essential Labeling Tools: Global Labeling for Medical Devices, Labeling Compliance Self Audits and Plain Language Writing for Labeling Professionals

    7:00-8:00 am  Tutorial Registration

    8:00-10:00am Global Labeling for Medical Devices
    Barbara J. Fanelli, MBA,MS
    Associate Vice President, Global Regulatory Affairs Labeling
    Sanofi U.S. Inc

    Gerrit-Jan Nijveldt, MSc
    Senior Director, Global Regulatory Affairs Labeling
    Sanofi U.S. Inc

    Today, companies use their own interpretation of regulations and guidelines when creating labeling for devices due to in part the limited device regulations and guidelines compared to the ones available for drugs. The goal of creating corporate labeling for devices is to provide the required information to the affiliate in a clear and concise format. The country can modify their local labeling, according to their regulations. This process ensures globally harmonized labeling. During this portion of the tutorial, the following will be discussed:

    • - Use of a so-called Company Core Device Manual (CCDM)
    • - Use of comprehension studies for the instructions
    • - Support for the core labeling and its local implementation
    • - Examples of labeling change

    10:00-10:30 am Refreshment Break

    10:30-12:30 pm Plain Language Writing for Labeling Professionals
    Kala L. Paul, MD
    President
    The Corvallis Group, LLC

    Almost 100 million Americans read at or below the 8th grade reading level, effectively cutting them off from much of our current written medical communication material. This portion of the tutorial explores conceptual and practical issues in generating plain language consumer medical communications, with practice in writing and evaluating communications that are easy to read, understand, and use. 

    • - Discuss how plain language principles can help improve readability of patient material
    • - Explain how to generate or revise written material using plain language principles to increase readability
    • - Practice using plain language principles for written communication

    12:30-2:00 Lunch

    2:00-4:00 pm  Labeling Self Audits
    Joseph McMillian
    Principal Partner
    Heartland Compliance Services LLC

    This presentation is designed to educate labeling and marketing professionals on methods for conducting a self audit.  The audit processes discussed in this course are not specific to any country.  They are designed to be applicable to any country and process which employs pharmaceutical labeling.

Day 1 Wednesday, Apr 09, 2014

  • 7:15AM - 8:15AM

    Registration and Continental Breakfast
  • 8:15AM - 8:30AM

    Welcome and Opening Remarks

    Speaker(s):

    • Steven W. Bass, PhD
      President
      Bass Biopharm Consulting Group LLC, United States
  • 8:30AM - 10:00AM

    Session 1 - EU Pharmacovigilance Guidelines – Impact on Global Labeling: Understanding the Issues


    Session Chair(s):

    • Barbara Lachmann, MD
      Barbara Lachmann Labeling Consulting, Germany

    This session will provide an overview of the potential impact of the EU Good Pharmacovigilance Practice Guidelines on Core Labeling processes and elucidate EU regulatory authority expectations of a company's safety labeling performance.

    Speaker(s):

    • Labeling-relevant Provisions in the EU's Good Pharmacovigilance Practice Guidelines
      Ralf Zerban, DrMed
      Managing Director
      Vigiserv GmbH, Germany
    • An EU Inspector's Approach to Reviewing a Company's Safety Labeling Performance
      Anna Toth, PharmD, MSc
      Pharmacovigilance Inspector, Drug Inspectorate Industry & Hospital
      Medical Products Agency, Sweden
  • 10:00AM - 10:30AM

    Networking, Exhibits, and Refreshment Break
  • 10:30AM - 12:00PM

    Session 2 - EU Pharmacovigilance Guidelines – Impact on Global Labeling: Strategies for Industry


    Session Chair(s):

    • A. Leander Fontaine, DrMed
      President
      Pharmiceutics, LLC., United States

    This session will provide a panel discussion on necessary elements of, or improvements to, the design of global labeling processes, policies and tools, such as: defined decision making responsibilities; integration/alignment with “signal management;” robust deviation management; performance measures and documentation; and implementation tracking and self-auditing

    Speaker(s):

    • Panelist
      Joseph McMillian
      Principal Partner
      Heartland Compliance Services LLC, United States
    • Panelist
      Ralf Zerban, DrMed
      Managing Director
      Vigiserv GmbH, Germany
    • Panelist
      Barbara Lachmann, MD
      Barbara Lachmann Labeling Consulting, Germany
    • Panelist
      Julie P. Retzinger, MBA, RN
      Director, Strategic Global Labeling
      Baxter Healthcare Corporation, United States
    • Panelist
      Gerrit Nijveldt, MSc
      Senior Director, Global Regulatory Affairs Labeling
      Sanofi US , United States
    • Panelist
      Rie Matsui, RPh
      Director, Regional Labeling Head for Asia International Labeling Group
      Pfizer Japan Inc., Japan
    • Panelist
      Megann Looker
      Celgene Europe Ltd., United Kingdom
    • Panelist
      Su-Yueh Lin, MS, RPh
      Sr. Director, Head of Regulatory Labeling
      Regeneron Pharmaceuticals Inc, United States
    • Panelist
      Takashi Misu
      Pharmaceuticals and Medical Devices Agency, Japan
    • Panelist
      Bruce Boulton, MSc
      Product Information Officer, Bureau Gastroenterology, Infection & Viral Diseases
      Health Canada, Canada
    • Panelist
      Anna Toth, PharmD, MSc
      Pharmacovigilance Inspector, Drug Inspectorate Industry & Hospital
      Medical Products Agency, Sweden
    • Panelist
      Mark A. Collins, PhD, MBA
      Senior Director, Risk Management
      Endo Pharmaceuticals Inc., United States
  • 12:00PM - 1:30PM

    Luncheon
  • 1:30PM - 3:00PM

    Session 3 - Tracking from Signal to Package


    Session Chair(s):

    • Julie P. Retzinger, MBA, RN
      Director, Strategic Global Labeling
      Baxter Healthcare Corporation, United States

    In this session we will examine the current regulatory environment regarding tracking of safety signals into prescribing information and then onto package. Additionally we will examine current IT tracking solutions, and how to implement globally.

    Speaker(s):

    • Tracking, from Safety Signal to Product Package
      Beth A. Lage, RAC
      Associate Director, Strategic Global Labeling
      Baxter Healthcare Corporation, United States
    • IT Perspective
      Craig S. Trautman
      CEO
      Intagras, Inc., United States
  • 3:00PM - 4:00PM

    Networking, Exhibits, and Refreshment Break
  • 4:00PM - 5:30PM

    Session 4 - From Labeling (Global and Local) Through Dossier Content Using XML - Extending the Value of Structured Content Management and Reuse


    Session Chair(s):

    • Gerrit Nijveldt, MSc
      Senior Director, Global Regulatory Affairs Labeling
      Sanofi US , United States

    This session will discuss opportunities to how XML and DITA (Darwin Information Typing Architecture ) are being used to link and reuse content from the CCDS to local labels and to link to parts of dossier. Use of XML is not new for labeling and eCTD, this is a new way of working to extend use of XML/DITA to link the CCDS (or local labeling text) directly into the supporting documents, for example, the clinical documents. The XML/DITA tool has been implemented in use in clinical documentation, narratives, protocols, biostatistics, SAP and global labeling. This will be discussed from labeling point of view but also from XML and DITA expert point of view describing opportunities and solutions.

    Speaker(s):

    • Introduction
      Gerrit Nijveldt, MSc
      Senior Director, Global Regulatory Affairs Labeling
      Sanofi US , United States
    • XML/DITA Tool
      Ole Rom Andersen
      Director / Co-founder
      DITA Exchange, United States
    • XML/DITA Tool
      Derek VanRheenen
      Principal Business Analyst
      Amgen Inc., United States
    • Use of XML/DITA from a Company Perspective
      Mitzi S. Allred, PhD
      Director, R&D Technical Information, Mgmt Clinical Sciences
      Sanofi, United States
  • 5:30PM - 6:30PM

    Reception

Day 2 Thursday, Apr 10, 2014

  • 7:30AM - 8:00AM

    Registration and Continental Breakfast
  • 8:00AM - 9:30AM

    Session 5 - Methods for Reducing Medication Errors


    Session Chair(s):

    • Barbara J. Fanelli, MBA, MS
      Associate Vice President, Global Regulatory Affairs Labeling
      Sanofi U.S. Inc., United States

    This session will examine methodology to optimize a drug’s name, labeling, and package design in an efforts to reduce the potential for medication errors in the drug selection process

    Speaker(s):

    • FDA Perspective
      Kellie Taylor, PhD, MPH
      Acting Director, Division of Medication Error Prevention and Analysis, CDER
      FDA, United States
    • Methods for Reducing Medication Errors
      Julie P. Retzinger, MBA, RN
      Director, Strategic Global Labeling
      Baxter Healthcare Corporation, United States
  • 9:30AM - 10:00AM

    Networking, Exhibits, and Refreshment Break
  • 10:00AM - 10:30AM

    Sessioin 6 - Recent Updates in EU Labeling


    Session Chair(s):

    • Megann Looker
      Celgene Europe Ltd., United Kingdom

    This session will discuss the new developments in labeling that have taken place in the last 12 months in the EU. Topics of discussion include: the impact of the Pharmacovigilance Legislation (March 2013), including additional monitoring and the Black Symbol; increased encouragement to report ADRs; and QRD v9. Revisions to the EU Guideline on the packaging of medicinal products in the EU (July 2013) and the EC Report on the Shortcomings of Product Information in the EU (Jan 2014) will also be discussed.

  • 10:30AM - 11:30AM

    Session 7 - Hot Topics in Canada


    Session Chair(s):

    • Mark A. Collins, PhD, MBA
      Senior Director, Risk Management
      Endo Pharmaceuticals Inc., United States

    In this session, plain language labeling will be discussed. Speakers will highlight the draft, published regulations concerning plain language labeling, an attempt to make drug labeling understandable by focusing on five targeted amendments which will provide: 1) a requirement for clear understandable, plain language labels; 2) required label mock-ups at time of review; 3) look-alike, sound-alike brand name assessments; 4) label contact information to report problems; and 5) a standard table format for key label information for nonprescription drugs. This session will also cover the final guidance, Labeling of Pharmaceutical Drugs for Human Use, highlighting changes from the 2010 draft and key points.

    Speaker(s):

    • Hot Topics in Canada: Draft Plain Language Labeling Regulations
      Bruce Boulton, MSc
      Product Information Officer, Bureau Gastroenterology, Infection & Viral Diseases
      Health Canada, Canada
    • Final Guidance – Labeling of Pharmaceutical Drugs for Human Use
      Bruce Boulton, MSc
      Product Information Officer, Bureau Gastroenterology, Infection & Viral Diseases
      Health Canada, Canada
  • 11:30AM - 12:30PM

    Luncheon
  • 12:30PM - 2:00PM

    Session 8 - Labeling in Asia


    Session Chair(s):

    • No-image Rie Matsui, RPh
      Director, Regional Labeling Head for Asia International Labeling Group
      Pfizer Japan Inc., Japan

    Many global companies operate a centralized labeling model in which the Company Core Data Sheet (CCDS) is handled by the headquarters organization while local healthcare professional information and patient leaflets are handled by staff based in local offices. This session will provide a case study discussion on the implementation of a regional hub model for Asia. The session will also explain labeling requirements for countries in Asia such as Japan, China, and Korea. In addition, PMDA will answer the frequently asked questions on unique Japanese regulations for labeling and practices in Japan. This information is particularly relevant for Western companies attempting to implement Core Safety Information in Japan.

    Speaker(s):

    • Implementation of an Innovative Labeling Hub in Asia including Japan and Integration with Global Model Point of View
      Rie Matsui, RPh
      Director, Regional Labeling Head for Asia International Labeling Group
      Pfizer Japan Inc., Japan
    • Q&A: Japanese Labeling Requirements
      Takashi Misu
      Pharmaceuticals and Medical Devices Agency, Japan
  • 2:00PM - 2:30PM

    Networking, Exhibits, and Refreshment Break
  • 2:30PM - 4:30PM

    Session 9 - FDA Labeling Update


    Session Chair(s):

    • Su-Yueh Lin, MS, RPh
      Sr. Director, Head of Regulatory Labeling
      Regeneron Pharmaceuticals Inc, United States

    This session will focus on recently published labeling guidances and provide an update on the Physician Labeling Rule (PLR). The following FDA labeling guidances will be discussed: 2013 Patient Counseling Information Section of Labeling (draft); 2013 Implementing the PLR Content and Format Requirements; 2013 Pediatric Information Incorporated into USPI (draft); 2012 Drug Interactions Studies: Labeling Recommendations (draft); and 2010 Dosage and Administration Section of Labeling.

    Speaker(s):

    • Content and Format of the United States Prescribing Information (USPI) for Human Prescription Drug and Biological Products: Update on Labeling Guidances
      Eric Brodsky, MD
      Labeling Team Leader, Study Endpoints & Labeling Dev, Immediate Office OND, CDER
      FDA, United States
  • 4:30PM - 4:45PM

    Closing Remarks

    Speaker(s):

    • Global Labeling 2014: Compliance in a Changing Regulatory Environment - The Final Presentation
      Gerrit Nijveldt, MSc
      Senior Director, Global Regulatory Affairs Labeling
      Sanofi US , United States

Exhibits  

The Global Labeling 2014 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
April 9-10, 2014

Useful Links

  • Idem Translations, Inc.
  • Intagras, Inc.
  • Opus Regulatory, Inc.
  • Reed Technology
  • Sciformix Corporation

Registration Fees 

Member

Member Government
$630.00
Member Academia
$785.00
Member Standard
$1570.00

Non-Member

NonMember Government
$855.00
NonMember Academia
$1010.00
NonMember Standard
$1795.00
Registration Fees for Additional Offerings
Tutorial 1 - Full Day Tutorial Rate
$755.00
Group Discounts

Printable Registration Form

Group Discount

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, please make a copy of the registration form 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

CANCELLATION POLICY: All cancellations must be received in writing two weeks before
the start of the event. 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 two weeks before the start of the event. Registrants who do not cancel two weeks before the start of the event and do not attend the event will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and airline reservations. 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.

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.

Participants with Disabilities:
Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

« Back to Listing Back To Top