ISO IDMP will be mandatory from July 1st 2016 and it will make a fundamental impact on the way the pharmaceutical industry is required to collect, manage and submit relevant data. Now is the last call for all marketing authorisation holders to (re)think their data submission policies and processes to make sure you close your IDMP implementation gaps in the next 12 month and have a clear vision of the next challenges lying ahead! Don’t miss out on the opportunity to get your questions answered, to benchmark the stage of your preparation, to initiate partnerships and to take an active part in designing the RIM’s community future agenda! Join us this summer in Berlin and gain valuable, practical information: # Learn how to assess and analyse data requirements for the IDMP standards by discussing possible interpretations with our expert from regulatory bodies on-site! # Benchmark your own IDPM Implementation process with peers from both big and mid-size pharma # Share insights how the IDMP standards are changing the interactions between IT-Systems, company departments, contract manufacturers and regulatory agencies # Discuss and compare with your peers experiences with vendors and solution providers offering help to achieve your IDMP implementation goals! For more information visit our website: http://bit.ly/EventWebsite If you would like to be part of the conference, you can register now here: http://bit.ly/Register-Event

1. Join us this summer in Berlin and gain valuable, practical information:
Learn how to assess and analyse data requirements for the IDMP
­standards by discussing possible interpretations with our expert on-site!
Benchmark your IDMP Implementation process with peers from both
big and mid-size pharma
Share insights how the IDMP standards are changing the interactions
between IT-Systems, company functions and regulatory agencies
International Conference
24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
Join our interactive workshops:
Wednesday, 24 June 2015 | Workshop
A: Preparation for the implementation of IDMP
Thursday, 25 June 2015 | Workshop
B: How to ensure IDMP compliance with limited resources?
Gain valuable insight from case studies
by the following companies:
• Boehringer-Ingelheim Pharma
GmbH Co. KG
• F. Hoffmann-La Roche Ltd.
• Marr Consultancy Ltd
• GE Healthcare
• A.E.Tiefenbacher GmbH Co. KG
• Bundesinstitut für Arzneimittel
und Medizinprodukte
• Bundesverband der
Arzneimittel-Hersteller e.V.
• MEDA Pharma GmbH Co. KG
• Mylan EPD, Inc.
• Janssen Pharmaceuticals, Inc.
• Novartis Pharma AG
• Pfizer Inc.
To Register | T +49 (0)30 20 91 33 88 | F +49 (0)30 20 91 32 10 | E eq@iqpc.de | www.IDMP-implementation-conference.com
Sponsors:
SA
V
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up
to
€
100,-w
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our
Early
Birds
ifyou
book
and
pay
by
30
April2014!
Dr. Andrew Marr,
Managing Director,
Marr Consultancy Ltd
Dr. Susanne Koch,
Head of Enterprise Architecture,
Boehringer-Ingelheim Pharma
GmbH
Dr. Jean-Michel Cahen,
IDMP Project Lead – DRA Region
Europe and Greater China,
Novartis Pharma AG
Highlight Speakers:
Dr. Jose Falcon,
Head Regulatory Affairs,
GE Healthcare
Elke Schydlo,
Associated Director Regulatory Affairs
Head Regulatory Operations,
Mylan EPD
Dr. Jaroslava Paraskevova,
Head of Documentation Information
Service, Regulatory Affairs,
MEDA Pharma GmbH Co. KG
How to cover gaps for IDMP implementation till July 1st
2016
The best conference to get the latest
updates on IDMP from regulatory bodies
benchmark your preparation with peers
from the pharma industry

2. Dear Colleagues,
Insiders suggest that IDMP will in fact be mandatory from July 1st
2016. Though
the implementation guidelines have not yet been published IDMP will make a
­fundamental impact on the way the pharmaceutical industry is required to collect
and standardise relevant information from many areas of the pharmaceutical
business, including regulatory affairs, research and development, manufacturing
and distribution.
Now is the last call for all marketing authorization holders to (re)think their
information management policies and processes and make sure you close your
IDMP implementation gaps in the next 12 months!
Our conference is dedicated to support companies in better understanding,
prioritizing and implementing strategies on the way into seamless and fully
compliant regulatory information and content management.
Don’t miss out on an opportunity to get many questions answered, to initiate
partnerships and to take an active part in designing the RIM’s community future
agenda!
See you in Berlin,
Dr. des. Jakub Deuretzbacher
Senior Projekt Manager
Sponsorship
We have a variety of packages available to
suit your requirements. For all Sponsorship
and Exhibition opportunities call us on:
+49 (0)30 20 91 32 75 or email
sponsorship@iqpc.de
Sponsors:
INFOTEHNA, a pioneer in regulated content,
publishing and process management soft-
ware solutions, bolsters global life sciences
companies to ensure Quality, Efficacy and
Safety of their products. Our unique, Integral
by Design myPharma Expert SuiteTM pro-
motes standardization, lightens complexity
and enables companies reduce overall prod-
uct lifecycle management efforts to achieve
sustainable compliance.
Media Partners
PharmaVOICE
Email: feedback@pharmavoice.com
Website: www.pharmavoice.com
PharmaVOICE magazine, reaching more than 34,000 BPA-qualified
life-sciences executives, is the forum that allows business leaders
to engage in a candid dialogue on the challenges and trends impact-
ing the industry. PharmaVOICE provides readers with insightful
and thought-provoking commentary in a multiple-perspective format
through forums, topics, and articles covering a range of issues from
molecule through market. PharmaVOICE subscribers are also kept
abreast of the latest trends and information through additional media
resources, including WebLinx Interactive WebSeminars, Podcasts,
Videocasts, White Papers, E-Surveys and e-Alerts. Additionally,
PharmaVOICEMarketplace.com provides a comprehensive directory
of products, services, and solutions for the life-sciences industry. To
RaiseYour VOICE, contact feedback@pharmavoice.com
Pharmcast
Website: www.PharmCast.com
www.PharmCast.com is the world leading website designed spe-
cifically for pharmaceutical, clinical and biotechnology professionals.
www.PharmCast.com brings upto- date information on pharmaceuti-
cal patents, FDA, news, jobs and Buyer's Guide to our visitors. It was
created and is maintained by pharmaceutical and biotechnology profes-
sionals. Visit www.PharmCast.com and discover for yourself why it is
so popular among professionals.
PharmaPhorum
Website: www.pharmaphorum.com
pharmaphorum drives innovation within the pharmaceutical industry,
by bringing healthcare together through a suite of media services that
help produce and disseminate thought leadership, combined with an
online platform for communicating messages to a global audience.
Technology Networks
Website: www.technolgynetworks.com
Founded in 2000, Technology Networks is now the leading provider
of free information services for academics and industry professionals
within the life science and drug discovery sectors. Our portfolio of 28
communities provides a base for members to access the latest news,
events, products and research from their chosen field. All communities
can be accessed throughTechnologyNetworks.com.
Pharma IQ
Website: www.pharma-iq.com
Pharmaceutical and biotech professionals make up the 60,000
strong global Pharma IQ community, benefitting from free mem-
bership to a unique pharmaceutical learning and networking portal.
Pharma IQ offers a unique multimedia platform for the commu-
nity to engage through a series of high level pharma conferences,
online events, training courses, articles, white papers, videos,
podcasts, webinars and reports.
Team Discounts
We are offering attractive Team
Discounts, please contact us!
International
To Register | T +49 (0)30 20 91 33 88 | F +49 (0)30 20 91 32 10 | E eq@iqpc.de | www.IDMP-implementation-conference.com

3. WORKSHOP
08:30 Registration coffee
Who is Who?
Learn about your peers and discover who else is
­participating in the conference! The matchmaking
wall helps you to identify the delegates you want
to meet at the conference.
09:20 Chairman’s welcome opening address
Dr. Bodo Antonic,
Institut for Health Management,
HTW Aalen
Scene setting – ISO work and EU roadmap
09:30 Progress with IDMP at an International Level
• International implementation plans
• ISO Implementation Guides
• HL7 model and messages
• International collaborations (GInAS, Controlled
­vocabularies etc)
Andrew Marr, Managing Director, Marr Consultancy Ltd
10:15 Speed Networking Session followed by a refreshment
and networking break
Connect in an informal way with your industry peers!
11:15 Update on EMA: What’s in the new proposals into the
EU ISO IDMP Task Force?
• Transition from the EVMPD codes to IDMP Codes
• Results from the preceding sessions
• Future obstacles and the way ahead
Dr. Andreas Franken, Clinical Research / eSubmission,
Data Safety Manager; Bundesverband der Arzneimittel-
Hersteller e.V.
12:00 Responding to the challenges of the EU roadmap:What
are the key issues to be addressed in order to comply?
• Focus on data: Link existing data and generate what is
missing
• Focus on systems: Find the right partner offering
­working solution
• Focus on processes: Avoid duplication of effort
Dr. Jose Falcon, Head Regulatory Affairs, GE Healthcare
12:45 Networking luncheon
14:15 Breakout Sessions
Parallel group discussions – join two out of five tables
hosted by experts and exchange your insights and
questions in a collaborative, non-competitive setting:
Table 1 – At what costs can you get the data without
changing the system?
How to assess your main areas of concern?
Table 2 – How to collect the right data from contract
manufacturers?
The 1st of July 2016 Marathon – Managing pre-projects
and assessing IDMP capabilities
Table 3 – Integration IT regulatory affairs
How can we support regulatory requirements with
IT tools and processes: Discussing formats, software
­solutions and process options
Table 4 – What’s new in the Medical Product
Implementation Guide?
Get an update on the latest specifications in the Medical
Product Implementation Guide
Table 5 – What’s new in the Substance Implementation
Guide?
Get an update on the latest specifications in the
Substance Implementation Guide
15:00 Back to the plenum: Presentation and summary of
groups’ discussion
15:30 Refreshment and networking break
16:00 What guarantees that you are ready on July 1st
2016 – The Roche approach
• From xEVMPD to ISO IDMP – Project early definition
and kick-off
• From timelines and prioritization to communication and
change management
• Ongoing developments and next steps: Make sure you
have a plan B
Dr. Quentin Darrasse, Global PDRO Quality Manager,
F. Hoffmann-La Roche Ltd.
16:45 Chairman’s closing remarks, Reception and networking at hotel
17:30- Evening Hands-On Workshop A:
19:30 Preparation for the implementation of IDMP
The workshop will address the interpretation of the
Medicinal Product guidance, identifying what data a
company might typically have available and what it is less
likely to be able to source. The best ways to address the
challenges of sourcing missing data and of remediation of
data to align with format requirements will be considered.
Focus will be applied to data with a high probability of
being required but may be most problematic to source.
Andrew Marr, Managing Director, Marr Consultancy Ltd
Opening
Keynote
Evening
Keynote
To Register | T +49 (0)30 20 91 33 88 | F +49 (0)30 20 91 32 10 | E eq@iqpc.de | www.IDMP-implementation-conference.com
Conference Day One | Wednesday, 24 June 2015
5 Reasons to Join Pharma IQ:
• Membership is FREE
• Gain industry insight into the latest developments and trends
• Benefit from our exclusive content
• Network with your peers
• Learn about our relevant conferences and benefit from
early-bird savings
www.pharma-iq.com

4. WORKSHOP
08:00- Hands on Breakfast Workshop B:
09:45 Special task force small and mid size companies: How to
ensure IDMP compliance with limited resources? In this
hands-on workshop we will discuss the special challenges,
appropriate solution strategies and possible short-cuts
for small and mid-size companies confronted with IDMP.
Attendees will gain valuable insight how a cost efficient
and effective strategy looks like and how to choose the
right partners from the vendor side.
09:50 Chairman’s welcome opening address
Dr. Bodo Antonic, Institut for Health Management, HTW
Aalen, HTW Aalen
Data analysis – overview
10:00 Case Study Data Analysis Big Pharma: Gap Analysis
Benefits and next Steps – Novartis Pharma
• Improve quality of existing data and collect missing data
• Revisit existing processes
• Get prepared for an IT solution
Dr. Jean-Michel Cahen, IDMP Project Lead – DRA Region
Europe and Greater China, Novartis Pharma AG
10:30 Case Study Data Analysis Mid-Size Pharma: Gap
Analysis and next Steps – Tiefenbacher
• Mid-size pharma experiences with data
• Looking out for a cost sensitive IT solution
• Establishing new processes
Dr. Maike Lubomierski, Director Regulatory Affairs,
A.E.Tiefenbacher GmbH Co. KG
11:00 Refreshment and networking break
Case examples of data analysis
11:30 Building a Datawarehouse for xEVMPD and IDMP
compliance
• The application of a theoretical framework to a perceived
need
• Overcoming data based obstacles
• How value can drive improvement
• Which comes first, the system or the process?
Dr. Elke Schydlo, Head Regulatory Operations, Mylan EPD
12:00 Implementing a product data base compliant with
IDMP requirements on NCAs’ side
• What are key elements to be considered
• How can data migration be realised
• How can double work be avoided and an efficient
­process be supported
Dr. Klaus Menges, Director, Bundesinstitut für
Arzneimittel und Medizinprodukte
12:30 Networking luncheon
Solution strategies for moving ahead
14:00 The new IDMP IT challenge and the link to Information
Architecture
• How to solve the IDMP problem based on Information
Architecture?
• How to integrate the cross-functional application
­landscape?
• How to gain holistic views on the medicinal products?
Susanne Koch, Head of Enterprise Architecture,
Boehringer-Ingelheim Pharma GmbH
14:30 Case Study Realization of a solution for a Mid-Size
Pharma: Stepwise Achievement of IDMP goal
• Implementation of a XEVMPD system
• Establishment of internal competence teams
• Definition of concept and processes for data collection
• Clarification of working processes for reporting
Jaorslava Paraškevova, Head of Documentation
Information Service, Regulatory Affairs,
MEDA Pharma GmbH Co. KG
15:15 Refreshment and networking break
15:45 From IDMP 11238 substance standard to GiNAS –
what is the next step towards global harmonization?
• ISO IDMP within an organisation
• What are the plans of alignment of data between RA,
QA, PcV, production, marketing, etc.
• What is on the horizon?
Dr. Thomas Balzer, Bundesinstitut für Arzneimittel
und Medizinprodukte and Vice Chairman of the Data
Network Board
16:15 How IDMP could enable the seamless flow of analyti-
cal data through your organisation
• Allotrope Foundation and Framework
• Data Lifecycle in IDMP
• Allotrope Data standard evaluation
• Analytical data in IDMP
• Regulatory Benefits of Allotrope Framework
Dr. Gerhard Noelken, Senior Director Technology
Innovations, Pfizer
16:45 The next steps after July 2016: Future developments of
IDMP and Information Management: What should we
have achieved in 2020?
Dr. Guido Claes, Director Master Data Management for
Pharma RD, Janssen
17:30 Closing Discussion: Have your say! –
Final comments questions from the audience
18:00 Chairman’s closing remarks and end of the conference
Closing
Keynote
To Register | T +49 (0)30 20 91 33 88 | F +49 (0)30 20 91 32 10 | E eq@iqpc.de | www.IDMP-implementation-conference.com
Conference Day Two | Thursday, 25 June 2015

5. 24 – 25 June 2015 | Steigenberger Hotel Berlin, Germany
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requirements. For all Sponsorship and Exhibition
opportunities call us: +49 (0)30 20 91 32 75 or email
sponsorship@iqpc.de
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