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Global AE Reporting: Drug Safety Requirements in the US and EU

Nov 12 2013 8:15AM - Nov 12 2013 5:15PM | Hyatt Regency Bethesda One Bethesda Metro Center 7400 Wisconsin Avenue Bethesda, MD 20814-5326

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This one day conference will cover intermediate-level content around the topics of collection, assessment, reporting and analysis of adverse events to meet global requirements.

Who Should Attend 

Professionals involved in:

  • Clinical Safety and Pharmacovigilance
  • Regulatory Affairs
  • Clinical Development
  • Medical Affairs
  • Quality Assurance

Learning Objectives 

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

  • Describe how to collect, assess, report and analyze adverse events
  • Discuss US and EU regulatory requirements for drug safety and describe this impact on safety reporting
  • Explain signaling analyses based on FDA and EMA requirements
  • Discuss the objectives and components of a pharmacovigilance audit
  • Describe the top ten findings from regulatory inspections for product safety

Hotel & Travel 

Hyatt Regency Bethesda
A limited number of rooms are available at the reduced rate shown below (rate is guaranteed until October 28, 2013, 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 is as follows: Attendees can follow this link or call +1.212.532.1660 or 1.800.221.3531 in the U.S. When calling please select option 1 for “Hotel Reservations,” and inform the phone agent that you are making a reservation for Event #13014.

Standard Room Rate $219

Hotel Address: 7400 Wisconsin Avenue, Bethesda, MD 20814

The most convenient airport is Reagan National Airport and 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-8:00 ET

Agenda Details
Colleen Braun, Content Lead
Phone +1.215.442.6160
Fax +1.215.442.6199

Event Logistics
Ellen Diegel, Event Planner
Phone +
Fax +1.215.442.6199

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 3 contact hours or .3 continuring education units (CEUs). Type of Activity: Knowledge

• Session 2: Post Marketing Safety Requirements: US and EU: 1.5 contact hours or .15 CEUs; 0286-0000-13-095-L04-P
• Session 4: Signal Detection/Data Mining/Risk Assessment/Risk Management/Risk Minimization: 1.5 contact hours or .15 CEUs; 0286-0000-13-096-L04-P

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 .7 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.

DIA’s Certificate Program
These programs are part of DIA’s Certificate Program and are awarded the following:
• Clinical Safety and Pharmacovigilance Certificate Program: 4 Elective Units
• Regulatory Affairs Certificate Program: 4 Elective Units

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

Name Credit Type Max Credits CEU
Global AE Reporting: Drug Safety Requirements ACPE 3.00 0.300
Global AE Reporting: Drug Safety Requirements IACET 6.50 0.700

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, sign-in at the DIA registration desk, 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, November 26, 2013.

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

Program Committee 

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Day 1 Monday, November 11, 2013

  • 6:00PM - 8:00PM


Day 2 Tuesday, November 12, 2013

  • 7:15AM - 8:15AM

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

    Welcome and Opening Remarks


    • Sylvie Tomczyk, MD,PhD
      Senior Medical Director
      EMD Serono, United States
  • 8:30AM - 10:00AM

    Session 1: Premarketing Reporting Obligations in EU and US

    Session Chair(s):

    • No-image Sylvie Tomczyk, MD,PhD
      Senior Medical Director
      EMD Serono, United States

    This session will describe the safety reporting requirements for drugs prior to market approval in the US and the EU region. This will help understand the key obligations and key differences between US and EU regions on individual and aggregate reporting to Health Authorities, IRB or investigators, clinical trial registration, signal detection and special reporting situations for development drugs.


    • Overview of Premarketing Safety Reporting Obligations in the US
      Michael Keatley
      Director, Local Safety Officer
      Janssen Scientific Affairs, LLC, United States
    • Overview of Premarketing Safety Reporting Obligations in Europe
      Vicki Edwards
      QPPV and Head of Affiliate Vigilance Excellence
      Abbvie Ltd., United Kingdom
  • 10:00AM - 10:30AM

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

    Session 2: Post Marketing Safety Requirements: US and EU

    Session Chair(s):

    • No-image Sylvie Tomczyk, MD,PhD
      Senior Medical Director
      EMD Serono, United States

    This session will describe the reporting requirements for marketed drugs in the US and the EU region, for individual and aggregate safety reports. This will help understanding the key obligations and key differences between these two regions, and yet the common goal towards updated, accurate safety information.


    • MedWatch from Spontaneous Report to FDA Alert and Beyond: An Overview of Incorporating Safety Information into Practice
      Heidi C. Marchand, PharmD
      Assistant Commissioner, Office of Health and Constituent Affairs, OC
      FDA, United States
    • Post Marketing Requirements (not requiems) EU amd US for Individudal Case Safety Reports
      Sylvie Tomczyk, MD,PhD
      Senior Medical Director
      EMD Serono, United States
    • Signal Management and Aggregate Safety Information Reporting with CoBRA(R), Best Practices According to EU/GVP Regulations
      Susanne Ramm, DrMed
      Medical Director
      Dr. Ebeling & Assoc GmbH, Germany
  • 12:00PM - 1:30PM

  • 1:30PM - 3:00PM

    Session 3: The Pharmacovigilance Audit

    Session Chair(s):

    • No-image Steve Jolley, MA
      Chief Executive Officer
      SJ Pharma Consulting, LLC, United States

    This session will give you a jump-start on how to prevent common problems that are found during regulatory inspections for drug safety and pharmacovigilance. It will include examples based on findings by the FDA and MHRA’s pharmacovigilance inspectors. You will be able to use this information straight away to make the changes you need to address these common failings and avoid the findings.


    • Avoiding the Top Ten Mistakes Companies Make in a PV Inspection
      Steve Jolley, MA
      Chief Executive Officer
      SJ Pharma Consulting, LLC, United States
  • 3:00PM - 3:30PM

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

    Session 4: Signal Detection/Data Mining/Risk Assessment/Risk Management/Risk Minimization

    Session Chair(s):

    • No-image Andre Daniels, MD,MS
      Executive Director, Global Regulatory Affairs and Safety
      Amgen, Inc., United States

    This presentation will describe methods for the detection and prioritization of signals from multiple data sources and the use of data mining in association with case by case evaluation for signal confirmation. Evidence available for risk assessment associated with the prescribing of medications will be discussed. Methods and challenges in evaluating risk management and risk minimization programs including REMS will be considered.


    • Detection, Evaluation, Mitigation and Reporting of Safety Issues through the Product Life Cycle
      Joanna Faith Haas, MD,MSc,FACPM,FISPE
      Founding Partner
      Haas and Partners LLC, United States
    • The Growing Use of Observational Studies in Risk Management Strategy
      J. Michael Sprafka, PhD,MPH
      Executive Director, General Medicine, Inflammation & Bone TA Lead
      Amgen Inc., United States
    • Methods and Challenges in Evaluating Risk Management and Risk Minimization Programs
      Paul J. Seligman, MD,MPH
      Executive Director Regulatory Policy
      Amgen, Inc., United States
  • 5:00PM - 5:15PM

    Closing Remarks


    • Andre Daniels, MD,MS
      Executive Director, Global Regulatory Affairs and Safety
      Amgen, Inc., United States

Registration Fees 


Charitable Nonprofit/Academia Member
Member Government
Member Standard


Charitable Nonprofit/Academia Nonmember
NonMember Government
NonMember Standard
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, 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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