MedDRA User Group Meeting - Boston, Massachusetts, USA
26 June 2008
1230 - 1700
Boston Convention and Exhibition Center
Room 210A
415 Summer Street
Boston, MA 02210

Agenda

Presentations

Meeting Minutes

MedDRA International User Group Meeting - Barcelona, Spain
6 March 2008
0900 - 1300
User Group meeting is FREE for MedDRA Subscribers.

Vincci Maritimo
Calle Llull 340
Esquina Selva de Mar
Barcelona 08019 Spain

Presentations

Introduction and Welcome	Pat Revelle
MedDRA SMQs	Astrid Herpers
Friend of MedDRA Award Networking / Coffee Break	Pat Revelle
MedDRA and European Regulatory Environment	Tomás Moraleda
Versioning - Best Practices	Sabine Brosch Patricia Mozzicato Pat Revelle
Subscriber Forum / Q&A	Patricia Mozzicato
Wrap Up / Lunch

Minutes

MedDRA User Group Meeting - Atlanta, Georgia, USA
21 June 2007, 12:30 - 5:00 PM
Georgia World Congress Center
285 Andrew Young International Blvd., N.W.
Atlanta, Georgia 30313-1591

Agenda

Presentations

MedDRA International User Group Meeting - Vienna, Austria
29 March 2007, 0900 AM- 1300 PM
Vienna Marriott Hotel
Parkring 12a
Vienna, 1010 Austria
Phone: 43 1 515180

NOTICE:    Items were left in the User Group meeting room in Vienna.  If you are missing items, please send a message to the MSSO help desk at mssohelp@ngc.com to arrange for retrieval.

MedDRA User Group Meeting - Philadelphia, Pennsylvania USA
22 June 2006, 12:45 - 4:45 PM
Pennsylvania Convention Center
1101 Arch Street
Philadelphia, Pa 19107

Agenda
           Introduction & Welcome (Pat Revelle) Various topics of interest to include: SSC Status, SMQs, Pricing, Translations, MedDRA Definitions, and Medication Error Definitions
           MedDRA & Pharmacovigilance in the EEA  (Sabine F. Brosch, EMEA, EU)
           MedDRA SOC Neoplasm & Combination Terms  (Dr. Patricia Mozzicato)
           MedDRA and Product Safety Labeling: Industry perspective, practical experience   (Ilona Große-Michaelis, Schering AG)
           Developing a Computable Highlights Section   (A. Leander Fontaine, PHARMICEUTICS LLC)

MedDRA International User Group Meeting - Paris, France
09 March 2006, 0900 - 1330
Hôtel Concorde La Fayette - Champs-Elysees
3, place du Général Koenig
75017 Paris

Agenda
           Introduction & MedDRA Discussion Topics:  Brief Updates,
           PTC Updates, Combination Terms, Classification Systems
           CTCAE Codes & MedDRA (Dr. Philippe Thouvay)
           MedDRA " Hot Topics"

MedDRA International User Group Meeting - Washington, DC
30 Jun 2005, 1300 - 1630
Washington Convention Center
Room 140A
Please join us for a light fare buffet lunch at 1245.

Agenda
Introduction and Welcome      Mr. Patrick Revelle, Director, MSSO  

   Guest Speakers

     Medication Errors         Dr. Linda Kim-Jung, Pharm.D.
     Use of MedDRA in the EEA and EudraVigilance
                                                    Dr. Sabine Brosch
     Updates on Standardised MedDRA Queries (SMQs)
                                                      Dr. Patricia Mozzicato  
     Supplemental Material - HLT/HLGT Feasibility Study doc
     HLT/HLGT Feasibility Study excel spreadsheets (Subscriber login required)                                                       
     MedDRA Version Reports

MedDRA International User Group Meeting - Lisbon, Portugal
10 Mar 2005, 0900 - 1300

Casablanca Room
Lisbon Marriott Hotel
Avenida dos Combatentes
Lisbon, 1600-042 Portugal

(Hotel Direction: 7 km N - Driving Directions: From The Airport; (north) A1 Or 'vasco Da Gama' Bridge; Take 2nd Circular Turn To Eixo Norte/sul Towards 'santa Maria Hospital' Turn Right By Catholic University. ** From Downtown, South Or 25 De Abril Bridge ; Follow Direction Praca De Espanha And Take Av. Dos Combatentes. The Lisbon Marriott Is On The Left Side Of The Avenue.)

Introduction and Welcome     Mr. Patrick Revelle, Director, MSSO  

    Guest Speakers
       Regulatory Update         Dr. Sabine Brosch
       Standardised MedDRA Queries (SMQs)
                                                     Dr. Christina Winter

MedDRA International User Group Meeting - Washington, DC
17 June 2004, 1300 - 1630
Washington Convention Center
Room 140 A

Agenda

      Opening Remarks          Mr. Patrick Revelle, Director, MSSO

      Regulatory Update:         
           FDA       Dr. Andrea Feight
           EMEA     Dr. Sabine Brosch    
           JMO       Mr. Yasuo Sakurai      

              Networking Break

      Standardised MedDRA Queries (SMQs)
                         Dr. Patricia Mozzicato

      Versioning   Mr. Patrick Revelle

      MedDRA Encoding by Investigators
                          Dr. Patricia Mozzicato

              Questions and Answers

      Minutes

MedDRA International User Group Meeting - Prague, Czech Republic
09 March 2004, 1300 - 1630
Prague Congress Centre
Club Room D

      Opening Remarks          Mr. Patrick Revelle, Director, MSSO

      Regulatory Update          Dr. Sabine Brosch, EMEA

      E2b ICSR Experience      Dr. Erik Rasmussen, Leo Pharma

              Networking Break

      Update on Standardised MedDRA Queries (SMQs)
                                              Dr. Patricia Mozzicato, MSSO

      MedDRA and Modifiers    Dr. Tomas Moraleda, IMO, MSSO

              Questions and Answers

      Minutes

EU MedDRA Informal User Group Web Page (requires log-in)

MedDRA International User Group Meeting - Rome, Italy
04 March 2003

• User Group Presentation
• MAG User Group
• Scope of MedDRA Break Out Session
• MAG Break-Out Session
• Rome User Group Meeting Minutes

• In conjunction with the DIA 39th Annual Meeting
• Time: 1:00 p.m. to 4:00 p.m.
  Location: Henry B. Gonzalez Convention Center, Rooms 210AB
• Presentations:
  • MedDRA/MSSO Overview (PowerPoint) - Jim Mundell
  • Standardized MedDRA Queries (PowerPoint) - Patricia Mozzicato
  • MedDRA Initiatives: The Current and the Future (PowerPoint) - JoAnn Medbery
  • Consider the Points to Consider (PowerPoint) - JoAnn Medbery
  • FDA Update on MedDRA (PowerPoint) - Andrea Feight

• Minutes

In conjunction with ICH-06

• Presentations:
  >MedDRA/MSSO Overview - Pat Revelle
  >Overview of Current Activities at the MedDRA Japanese
     Maintenance Organization (JMO) - Yasuo Sakurai
  >Update from the FDA Regarding Regulatory
     Requirements - Andrea Feight DMD, MPH
  >Implementation Status in the European Union - 
     Dr. Sabine Brosch   EMEA, UK
  >Updates of Regulatory Requirements in Japan - 
     Tomiko Tawaragi
  >MedDRA Term Selection:  Points to Consider Document
    Presentation to MedDRA Users Group - Toni Piazza-Hepp,
     Pharm.D. U.S. FDA 
  >Progress of CIOMS/MSSO on MedDRA Data Analysis - 
     Pat Revelle 
  
  
• Minutes

MedDRA International User Group Meeting - Japan
15 November 2002

• Implementation of MedDRA/J From Pharmaceutical Industry's Point of View (PowerPoint)
• JMO Overview (PowerPoint)
• Update From the MSSO User Group Meeting (PowerPoint)
• Electronic Submission of ADR Report and Use of MedDRA/J (PDF)
• Japan User Group Meeting Minutes (Word document)

• MedDRA MSSO User Group Slides (PDF)
• Status of Regulatory Implementation (PDF)
• Chicago User Group Minutes (Word document)
• Breakout Sessions
  • DIA Breakout Summary (Word document)
  • Notes From Breakout Session on Data Analyss/Signal Detection (Word document)

• Basel User Group Minutes, 5 Mar 2002 (PDF)
• MedDRA MSSO Overview for Users (PowerPoint)
• Status of Regulatory Implementation (PowerPoint)

• User Group Agenda and Overview (12 July 2001) (PDF)
• MedDRA Implementation (12 July 2001) (PDF)
• Status of Regulatory Implementation (12 July 2001) (PDF)
• Implementing MedDRA (12 July 2001) (PDF)
• MSSO Recommendations for MedDRA Versioning (12 July 2001) (PDF)
• BMS Approach to MedDRA Versioning (12 July 2001) (PDF)

• MedDRA MSSO Overview for Users (6 Mar 2001) (PDF)
• AstraZeneca Implementation of MedDRA within Global Drug Safety (6 Mar 2001) (PDF)
• Aventis Experience in Recording Safety Data with MedDRA (6 Mar 2001) (PDF)
• MedDRA & Joint Pilot for Implementation of Electronic Transmission of ICSRs (6 Mar 2001) (PDF)

• MedDRA Japan 2000 User Group Meeting Minutes (PDF)
• MSSO User Group Overview, MSSO (PDF)
• Kazuo Hirayama, Managing Director, JMO (PDF)
• Andrea Neal, DMD, MPH, Office of Post-Marketing Drug Risk Assessment, Center for Drug Evaluation and Research (PDF)
• Emer Cooke, Enterprise Directorate General European Commission (PDF)
• Takashi Yasukawa Ministry of Health and Welfare, Japan Ministry of Health and Welfare, Japan (PDF)
• Bill Gregory, Pfizer Inc. (PDF)
• Steen Ottosen, EU Pilot on E2B Submission (PDF)
• Tadao Akiyama, Information Management, Japan Drug Surveillance, Pharmacia&Upjohn (PDF)
• Maggie Westland, Term Selection Working Group under the MedDRA Management Board (PDF)