An Introduction to Product Information Management (PIM)

Brand New Training Course!

COURSE OVERVIEW KEY TOPICS PIM is a new method of submitting product information in the Centralised Procedure (CP). With more than 20 different languages in the EU leading to 1000 or more documents for a single trade • PIM Essentials name, there is an increased burden on applicants and authorities to handle information for • Initial Submissions packaging leaflets and product characteristics, especially during the time critical translation process. PIM has been introduced by the EMEA to increase efficiency during exchange of product • Comment Handling information and improve the quality and constancy of product information. • Translation Process This training course is designed to give the participants a good understanding about Product • PIM Variations Information Management, the PIM submission process and variations, the translation process and comment handling as well as the exchange standard and templates used. • LAT – The Light Authoring Tool

WHO WILL ATTEND LEARNING OBJECTIVES Professionals in: Document Management At the conclusion of this course, participants should be able to: Information Technology / e-Business Marketing / Advertising • Explain the procedures for Product Medical Communications / Information Information Management Manufacturing: Drug Substance, Drug Product, Packaging • Discuss the Product Information Management Quality Control / Quality Assurance submission process and variations Regulatory Affairs / Policy / Drug or Device Approval / GRP • Describe the translation process and comment handling COURSE INSTRUCTORS • Recognise the exchange standard and templates Olaf Schoepke, PhD Managing Director, Extedo Limited, UK Maren von Fritschen, PharmD Director Regulatory Affairs, PharmaLex GmbH, Germany

EMEA Speaker Invited

Expert Speakers Invited

The Drug Information Association (DIA) has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102.

DIA is authorised by IACET to offer 1.3 CEUs for this programme.

If you would like to receive a statement of credit, you must attend the programme, return your evaluation form and complete the online credit request process through My Transcript at www.diahome.org. Participants will be able to download a statement of credit upon successful submission of the credit request.

Disclosure Policy It is Drug Information Association policy that all faculty participating in continuing education activities must disclose to the programme audience (1) any real or apparent conflict(s) of interest Course ID# 09534 related to the content of their presentation and (2) discussions of unlabelled or unapproved uses of cáêëí=a~ó=_ÉÖáåëW=MVWMM=== drugs or medical devices. Faculty disclosure will be included in the course materials. båÇ=a~ó=`çåÅäìÇÉëW=NTWPM

NH Harrington Hall , UK May 14-15, 2009 This course has limited capacity. Register early! MAY 14 DAY 1 MAY 15 DAY 2

08:00 Registration 09:00 Introduction, logistics, and overview of learning objectives of day 2 09:00 Introduction, logistics, and overview of learning objectives of day 1 09:15 Session 5

09:15 Session 1 TRANSLATION PROCESS

PIM ESSENTIALS The purpose of this session is to share information about possible translation automation and manual processes in the The purpose of this session is to give the participants an tight time lines given by authorities. overview about Product Information Management (PIM), the terminology used and the PIM process. It also presents the basic • Product translation information PIM exchange format with the authorities and the challenges • Introduction to translation technology faced. • Impact assessment • Internal/external translations • Basic PIM terminology • Machine and computer assisted translations • The PIM process and advantages • Translation memories • Exchanging information with authorities • Structures labelling content, meta data, and style 10:45 Coffee Break sheets • Structured Product Labelling (SPL) 11:15 Session 6

10:45 Coffee Break PIM CASE STUDY

11:15 Session 2 The objective of this session is to present a real case study, giving the participants first hand knowledge about the PIM SESSION 2: THE AGENCY VIEW submission process and complexity.

The purpose of this session is to give the participants an • How to plan and prepare your company for PIM overview of the current status of PIM submissions at the EMEA. submissions • Interaction and communication with the agency • Current status of the PIM project • The transition process • The PIM Review System PRS • Experience gained • The PIM submission process and agency requirements • Current time lines, restrictions, and constraints 12:45 Lunch • Advantages of moving to PIM • The PIM review process from the agency perspective 14:00 Session 7

12:45 Lunch PIM POST AUTHORISATION

14:00 Session 3 The Post Authorisation process and its complexity.

INITIAL SUBMISSIONS • Preparing for PAP • Business requirements and modelling The purpose of this session is to give the participants an • Parallel post authorisation procedure overview of the initial PIM submission, the processes triggered, • Practical exercise: PAP adaptation on business model and the procedures required. 15:30 Coffee Break • Authoring and validation of content • Publishing structured labelling content to different 16:00 Session 8 formats • Integration with Submission Management Systems LAT – THE LIGHT AUTHORING TOOL • Translation to multiple languages • PIM data exchange with the authorities Authorities supply the free LAT (Light Authoring Tool) to allow applicants to submit in PIM format. This session looks at the 15:30 Coffee Break advantages and disadvantages of going down this route.

16:00 Session 4 • Functionality LAT • Working practice LAT PRACTICAL EXERCISE: • Considerations, advantages and disadvantages THE INITIAL SUBMISSION PROCESS 17:30 End of Training Course The objective of this session is to let participants gain first hand experience in undertaking the initial submission process and learn about its complexity.

• Processes and procedures required • Building a product hierarchy • Working with QRD templates “Unless otherwise disclosed, DIA acknowledges that the • Authoring of source documents statements made by speakers are their own opinion and not • The validation process necessarily that of the organization they represent, or that 17:30 End of Day One of the Drug Information Association.”

17:30 Reception

O HOTEL INFORMATION Register for upcoming DIA training courses in 2009

Clinical Research Essentials of Clinical Study Management February 18-20, 2009 / Madrid, Spain / ID# 09528 The DIA has blocked a limited number of rooms at the: September 16-18, 2009 / Copenhagen, Denmark / ID# 09546 December 2-4, 2009 / Basel, Switzerland / ID# 09550 NH Harrington Hall 5-25 Harrington Gardens Practical GCP Compliance Auditing of Trials & Systems South Kensington October 7-9, 2009 / London, UK / ID# 09548 London Clinical Statistics for Nonstatisticians SW7 4JB October 8-9, 2009 / London, UK / ID# 09549 United Kingdom Regulatory Affairs European Regulatory Affairs Telephone: +44 207 396 1718 February 18-19, 2009 / Nice, / ID# 09537 Fax: +44 207 396 1513 June 11-12, 2009 / Amsterdam, The Netherlands / ID# 09538 Website: www.harringtonhallhotel.co.uk September 10-11, 2009 / Frankfurt, Germany / ID# 09539 November 19-20, 2009 / , France / ID# 09540

at the special rate of: Building the eCTD February 19-20, 2009 / Madrid, Spain / ID# 09541 Single room: GBP 153.00 per room per night September 17-18, 2009 / Copenhagen, Denmark / ID# 09542

Rate includes breakfast. Comprehensive Training on European Regulatory Affairs: An Overview May 6-8, 2009 / Basel, Switzerland / ID# 09544 November 25-27, 2009 / Lisbon, Portugal / ID# 09552 To reserve a room, please call the Reservations Department on An Introduction to Product Information Management (PIM) +44 207 396 1718 mentioning the keyword “DIA”. You can May 14-15, 2009 / London, UK / ID# 09534 also reserve a room online by using the link from the DIA October 15-16, 2009 / , Germany / ID# 09535 website: www.diahome.org > Educational Offerings > keyword: 09534 US Regulatory Affairs October 19-22, 2009 / Basel, Switzerland / ID# 09525

IMPORTANT: To be assured of accommodation at the NH Harrington Non-Clinical Sciences Hall, registrants are recommended to complete their reservation by Non-Clinical Safety Sciences and their Regulatory Aspects May 4-8, 2009 / Basel, Switzerland / ID# 09543 April 14, 2009. November 23-27, 2009/Lisbon, Portugal / ID# 09551

Safety and Pharmacovigilance Excellence in Pharmacovigilance: Clinical Trials and Post Marketing February 9-13, 2009 / Paris, France / ID# 09526 October 12-16, 2009 / Berlin, Germany / ID# 09527

Medical Approach in Diagnosis and Management of ADRs September 17-18, 2009 / Paris, France / ID# 09532

Practical Guide for Pharmacovigilance: Clinical Trials and Post Marketing May 13-15, 2009 / London, UK / ID# 09545 November 18-20, 2009 / Paris, France / ID# 09547

EudraVigilance Information Day July 1, 2009 / EMEA, London, UK / ID# 09529 November 4, 2009 / EMEA, London, UK / ID# 09530

EudraVigilance (EV) and EudraVigilance Medicinal Product Dictionary (EVMPD) Courses throughout the year / EMEA, London, UK For course details on EV, please visit www.diahome.org > Educational Offerings > EudraVigilance > Click on Related Courses

P FAX YOUR COMPLETED REGISTRATION FORM TO: +41 61 225 51 52 The DIA Europe Customer Services Team will be pleased to assist you with your registration. Please call us on +41 61 225 51 51 from Monday to Friday between 08:00 and 17:00 CET, or email us at [email protected]

If DIA Europe cannot verify your EGISTRATION ORM membership upon receipt of R F - ID# 09534 registration form, you will be charged the non-member fee. An Introduction to Product Information Management (PIM) Registration fee includes course material and refreshment breaks. May 14-15, 2009 - NH Harrington Hall, London, UK Registration will be accepted by mail, fax, email or online at www.diahome.org

MEMBER NON-MEMBER NON-MEMBER (with optional membership) (without optional membership) REGISTRATION FEES FEE TOTAL FEE MEMBERSHIP TOTAL FEE TOTAL Industry € 1’365.00 € 1’365.00  € 1’365.00 € 130.00 € 1’495.00  € 1’495.00 €1‘495.00  Government/Academia (Full-Time) € 683.00 € 683.00  € 683.00 € 130.00 € 813.00  € 813.00 € 813.00 

TOTAL AMOUNT DUE: € ______NOTE: Payment of registration fees must be received before commencement of the training course.

Please indicate your areas of professional interest: 09534 DIAWEB

 AH - Academic Health Centres  FI - Finance  MH - Managed Healthcare  PH - Pharmacology  AM - Alternative / Herbal Medicine  EC - e-Clinical  MN - Manufacturing: Drug Substance,  PK - Pharmacokinetics / Metabolism /  BT - Biotechnology  GC - GCP Drug Product, Packaging Pharmacodynamics  CD - Clinical Data Management  GE - Generic Manufacturing  MW - Medical / Scientific Writing  PM - Project Management  CH - Chemistry / Drug Design  GL - GLP  NC - Non-clinical Safety & Efficacy / Toxicology  PP - Public Policy / Law  CL - Clinical Laboratory Data  GM - GMP  NH - Natural Health Products  QC- Quality Control / Quality Assurance  CM - CMC  IM - Information Management  OS - Outsourcing / Virtual Development  RA - Regulatory Affairs / Policy / Drug or  CP - Clinical Safety/Pharmacovigilance  IMP - Impact  OT - Over the Counter Device Approval / GRP  CR - Clinical Research & Development  IS - Investigator Site  PC - Pharmaceutics  RD - Research & Development / Strategic Issues  CS - Clinical Supplies  IT - Information Technology / e-Business  PD - Professional Development  ST - Statistics / Biostatistics / Mathematical  DC - Dictionaries / Data Standards  LA - Legal Affairs  PE - Pharmacoepidemiology / Quality of Life / Modelling  DE - Devices  MA - Marketing / Advertising Health Economics / Outcomes Research /  TR - Training  DM - Document Management  MC - Medical Communications / Information Managed Healthcare  VA - Validation

REGISTRANT  Prof.  Dr.  Ms.  Mr. PAYMENT METHODS  Please charge my credit card - credit card payments by VISA, Mastercard or AMEX can be Last Name made by completing the relevant details below. Please note that other types of credit card cannot be accepted. First Name  VISA  MC  AMEX Company Card Number Job Title Exp. Date Street Address / P.O. Box Cardholder’s Name

Date Cardholder’s Signature Postal Code  Cheques should be made payable to: Drug Information Association. Mail your cheque City together with the registration form to facilitate identification of attendee to: DIA Europe, Country Elisabethenanlage 25, Postfach, 4002 Basel, Switzerland.  Bank transfers When DIA Europe completes your registration, an email will be sent to the Telephone address on the registration form with instructions on how to complete the bank transfer.

Fax (Required for confirmation) Payment should be in EURO and your name and company, as well as the course ID# 09534 and invoice number, must be included on the transfer document to ensure correct allocation Email (Required for confirmation) of your payment. Payments must be net of all charges and bank charges must be borne by the payee. Please indicate your professional category:  Academia  Government  Industry  Contract Service Organisation Persons under 18 are not allowed to attend DIA meetings.

CANCELLATION POLICY Cancellations must be made in writing and be received at the DIA Europe office by 17:00 CET on May 7, 2009. Cancellations received by the date above are subject to an administrative fee: Industry (Member/Non-Member) = EUR 200.00 / Government and Academia (Member/Non-Member) = EUR 100.00 Registrants who do not cancel by the date above, and do not attend, will be responsible for the full registration fee. Registrants are responsible for cancelling their own hotel and travel reservations. If an event is cancelled, DIA Europe is not responsible for airfare, hotel or other costs incurred by registrants. DIA Europe reserves the right to alter the venue and dates if necessary.

TRANSFER POLICY You may transfer your registration to a colleague prior to the course start but membership is not transferable. Substitute registrants will be responsible for the non-member fee, if applicable. Please notify the DIA Europe office of any such substitutions as soon as possible.

If you have not received your confirmation letter within five working days, please contact us. DIA, Elisabethenanlage 25, Postfach, 4002 Basel, Switzerland / Phone: +41 61 225 51 51 / Fax: +41 61 225 51 52 Email: [email protected] / www.diahome.org