Programme Committee

Peter ArlettHead of Sector Pharmacovigilance and Risk Management, European Medicines Agency (EMA), EU

Sabine BroschBusiness Lead, EudraVigilance and International Standardisation in Pharmacovigilance, European Medicines Agency (EMA), EU

Gaby DananPharmacovigilance Expert, France

Vada PerkinsU.S. Food and Drug Administration (FDA), CBER, US

Programme Faculty

Tim Buxton, Head of Sector, ICT Development, European Medicines Agency (EMA), EU

Lawrence CallahanU.S. Food and Drug Administration (FDA), US

Ilaria Del SeppiaEuropean Medicines Agency (EMA), EU

Raun KupiecSenior Director, Regulatory Affairs Europe, Process Management Group, Genzyme Europe, NL

Details of the Information Day

Location: European Medicines Agency Canary Wharf 7 Westferry Circus London E14 4HB, UK

Capacity: The event is limited to 120 participants

Course Overview2012 will see further progress towards final versions of the five new international Identification of Medicinal Product (IDMP) standards and the development of the ICH Implementation Guide (topic M5). The final draft international standards (FDIS) were released for ballot by 16 of April 2012, with the final standards expected by end of 2012. The key features of the new standards, the results of the ICH alpha testing and the key principles outlined in the ICH IDMP Implementation Guide will be presented and explained. In addition, the technical and process related aspects will be addressed, allowing pharmaceutical companies to prepare for a coordinated, well organised approach in putting the new standards into operation, taking into account the timelines and requirements as set out in the new EU pharmacovigilance legislation. The latest developments in the context of the implementation of Article 57 will also be addressed.

Key Topics• Update on the latest IDMP international standardisation activities and progress at the level of the ICH

M5 EWG • Key principles of the ISO IDMP standards with the main focus on medicinal product and substance

identification and related concepts presented by FDA and EMA• Identification of medicinal products from an industry perspective • Questions and Answers on Article 57 implementation

Learning ObjectivesAt the conclusion of this course, participants should be able to:• Understand the ongoing international standardisation work on IDMP• Recognise the main new features of the IDMP standards• Prepare medicines regulatory authorities in the EU, IT vendors and pharmaceutical companies for the

implementation of the new IDMP standards and adaptation of their regulatory product management and pharmacovigilance systems

• Understand the requirements for the electronic submission of medicinal product information by marketing authorisation holders to the Agency, in compliance with the new pharmacovigilance legislation

Who Will Attend• Regulatory affairs staff of pharmaceutical companies• Representatives of IT departments of medicines regulatory authorities, pharmaceutical companies and

service providers• EU Qualified Persons responsible for Pharmacovigilance (EU QPPVs)• Pharmacovigilance staff of pharmaceutical companies and medicines regulatory authorities• Medicinal product management software vendors• Sponsors of clinical trials

European Medicines Agency: The New Identification of Medicinal Products (IDMP) International Standards, ICH M5/M2 and the Implementation of Electronic Submission of Medicinal Product Information in the EU (Article 57(2) Requirements of the New Pharmacovigilance Legislation) Information Day

Course #125378 May 2012 European Medicines Agency | London, UK

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Unless otherwise disclosed, DIA Europe acknowledges that the statements made by speakers are their own opinion and not necessarily that of the organisation they represent, or that of the DIA Europe.

Speakers and agenda are subject to change without notice. Recording of any DIA Europe tutorial/workshop information in any type ofmedia, is prohibited without prior written consent from DIA Europe.

TUESDAY | 8 MAY 2012

08:15 Registration

08:45 Welcome NotePeter Arlett, European Medicines Agency, EU

Chairpersons for the whole day:Sabine Brosch and Vada Perkins

09:00 Session 1

Introduction to the International standardization and identification of medicinal products topic

The development of the international IDMP standards arising from the ICH topics M5 are close to finalisation and implementation. This session will provide an overview of the various activities at international level in order to progress with the finalisation of the standards and the drafting of an ICH IDMP Implementation Guide, as well as the activities in relation to the implementation of Article 57 requirements in the EU. An industry view will also be provided on the challenges with regard to the impact of product identification on different business processes. The Health Level Seven (HL7) Structured Product Labelling (SPL) and the FDA perspective on how it will work with the ISO IDMP will conclude this session.

International standardisation and the implementation of Article 57 – current status and next steps Speaker: Sabine Brosch, EMA, EU

An industry view on identifying medicinal products: IDMP, XEVMPD, ICSR and serialisation Speaker: Raun Kupiec, Genzyme Europe, NL

Health Level Seven (HL7) Structured Product Labelling (SPL): an overview and implementation by FDA implementation Speaker: Vada Perkins, FDA, CBER, US

10:45 Coffee break

11:00 Session 2

ISO IDMP substance identification and how it is applied in practice

This session will provide a detailed overview of the ISO FDIS 11238 “Health Informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances” that has been developed to define the concepts required for the unique identification of substances at an international level. Furthermore, the concept of a specified substance has been elaborated allowing capturing more detailed characteristics of substances. This can relate to, for example, intermediate products that contain multiple substances or specified substances of diverse origin and take into account features such as physical forms, constituents, components, marker substances, additives, impurities, manufacturing information, critical production processes, etc. Various examples for different substance classes will be presented to illustrate the specific concepts to be applied according to the FDIS. The use of HL7 messages for the information exchange on substances will be also discussed.

Speaker: Lawrence Callahan, FDA, USDiscussants: Panagiotis Telonis, EMA, EU, Ilaria del Seppia, EMA, EU

12: 30 Lunch break

13:30 Session 3

ISO IDMP medicinal product identification and how it maps to Article 57 in the EU and FDA’s implementation of HL7 SPL

This session will be dedicated to providing participants with an overview of the main changes introduced in the ISO FDIS 11615 and 11616 standards. They have been developed to characterise and uniquely identify regulated medicinal products and pharmaceutical products during their entire life cycle from development, to approval and marketing. More specifically, the standards establish definitions and concepts and describe data elements and their structural relationships, which are required for the detailed description and unique identification of medicinal products. The way these two standards relate to current Article 57 implementation in the EU and the product listing implemented by FDA will be also presented.

Speakers: Sabine Brosch, EMA, EU and Vada Perkins, FDA, USDiscussant: Panagiotis Telonis, EMA, EU

15:00 Coffee break

15.30 Session 4

Messaging for IDMP

This session will provide participants with an overview of the IDMP messages that support the electronic submission of information on medicines. Speaker: Tim Buxton, EMA, EU

16.00 Session 5

Questions and Answers on Article 57 implementation

This session will provide participants with the opportunity to familiarise themselves with specific implementation aspects that need to be taken into account and to raise practical questions from a technical and implementation perspective.

Speaker: Ilaria del Seppia, EMA, EUDiscussant: Veronika Soldanova, Krishna Caulee, EMA, EUPedro Oliveira, European Medicines Agency, London, EU

17:00 End of Information Day

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HOTEL INFORMATION

Recommended Hotel:

Hilton London Docklands Riverside265 Rotherhithe Street, London , SE16 5HW, UKTelephone: +44 (0)20 7231 1001Fax: +44 (0)20 7231 0599Email: reservations.docklands@hilton.com

DIA was able to negotiate a special rate for participants of the Information Day: Room rate is GBP 139.00 per room incl. breakfast excl. VAT

To book a room, click here. Please fill in corporate account number: 481223696.

The hotel is situated opposite of Canary Wharf conveniently connected by a shuttle boat. The landing stage is in walking distance to the European Medicines Agency (2 min). The ferry ticket is included in the room rate. Please make sure you receive it when checking in.

For further information, please go to http://www1.hilton.com/en_US/hi/hotel/LONNDHI-Hilton-London-Docklands-hotel/index.do

DIA 2012 Training Courses in Safety and Pharmacovigilance

Benefit/Risk Management

24-25 May 2012 | Location to be confirmed | ID 12561

Excellence in Pharmacovigilance: Clinical trials and post-marketing

1-5 October 2012 | Vienna, Austria | ID 12566

How to Prepare for Pharmacovigilance Audits and Inspections

May 2012 | Basel, Switzerland | ID 12556

November 2012 | Location to be confirmed | ID 12575

Introduction to Signal Detection and Data Mining in Pharmacovigilance

May 2012 | Basel, Switzerland | ID 12555

November 2012 | Location to be confirmed | ID 12574

Medical Approach in Diagnosis and Management of ADRs

October 2012 | Paris, France | ID 12565

Practical Guide for Pharmacovigilance: Clinical trials and post-marketing

21-23 May 2012 | Berlin, Germany | ID 12562

EudraVigilance Information Day at the European Medicines Agency

30 May 2012 | London, United Kingdom | ID 12533

21 September 2012 | London, United Kingdom | ID 12534

IDMP Information Day at the European Medicines Agency

4 December 2012 | London, United Kingdom | ID 12536

ICSR Information Day at the European Medicines Agency

4 May 2012 | London, United Kingdom | ID 12535

Introduction to Pharmacovigilance and Electronic Transmission of Individual

Case Safety Reports (ICSR) for the Use of Eudravigilance at the European

Medicines Agency

17 April 2012 | London, United Kingdom | ID 12538

16 October 2012 | London, United Kingdom | ID 12539

20 November 2011 | London, United Kingdom | ID 12540

EudraVigilance (EV) and EudraVigilance Medicinal Product Dictionary

(EVMPD)

Courses throughout the year | European Medicines Agency, London,

United Kingdom and selected European cities.

For course details on EV, please visit www.diahome.org >

Training > EudraVigilance > Click on > Related Courses

About DIA

The DIA is a global association of approximately 18,000 members who are involved in the discovery, development, regulation, surveillance or marketing of pharmaceuticals or related products. The DIA is committed to the broad dissemination of information on the development of new medicines or generics, biosimilars, medical devices and combination products with continuously improved professional practice as the goal. The DIA is an independent non-profit organisation. The voluntary efforts of DIA members and speakers allow the DIA to organise conferences, workshops and training courses and provide publications and educational material.

DIA’s headquarters are in Horsham, PA, USA, with the European office in Basel, Switzerland, and other regional offices in Tokyo, Japan, Mumbai, India, and Beijing, China.

For more information, visit www.diahome.org or call DIA Europe on +41 61 225 51 51.

REGISTRATION FORMDIA/EMA Excellence in Pharmacovigilance: Clinical Trials and Post-Marketing Training Course1-5 October 2012 | Hotel Novotel Praha Wenceslas Square, Prague, Czech Republic

ID #12537

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REGISTRATION FORMThe IDMP and eSubmission of MPI in the EU (Article 57(2) Information Day8 May 2012 | European Medicines Agency | London, United Kingdom

Standard Fee EUR 300.00

Reduced Fee for Academia and Full Government EUR 150.00

Note: Payment of registration fees must be received before commencement of the course