SlideShare a Scribd company logo
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
E
up
to
€
300,-w
ith
our
Early
Birds
ifyou
book
and
pay
by
29
M
ay
2015!
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
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
Sponsors:
		 INFOTEHNA, a pioneer in regulated content, 	
		 publishing and process management software 	
		 solutions, bolsters global life sciences companies
to ensure Quality, Efficacy and Safety of their products. Our unique, Integral
by Design myPharma Expert SuiteTM promotes standardization, lightens
complexity and enables companies reduce overall product lifecycle manage-
ment efforts to achieve sustainable compliance.
CUNESOFT GmbH
Marsstrasse 4
80335 Munchen
Germany
www.cunesoft.com
PAREXEL
GIBRALTA RD, SUITE 200, HASHAM
PA 19044
USA
www.parexel.com
LORENZ Archiv-Systeme GmbH
Eschborner Landstraße 75
60489 Frankfurt am Main
Germany
Alba Lenertz
LORENZ Life Sciences Group (www.lorenz.cc) has been developing
and marketing software solutions for the Life Sciences market since
1989. LORENZ's solutions are geared specifically for submission
assembly, review, publishing, validation and management. LORENZ
docuBridge® is the most widely used eCTD submission management
system for U.S., European and Japanese formats among many others,
and is popular with regulatory agencies and industry alike. With over
400 installations in over 25 countries, LORENZ has a strong worldwide
customer base.
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 impacting 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, includingWebLinx InteractiveWebSeminars, 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 specifically for pharmaceu-
tical, clinical and biotechnology professionals. www.PharmCast.com brings upto- date
information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors.
It was created and is maintained by pharmaceutical and biotechnology professionals. 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 discov-
ery 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 membership to a unique pharmaceutical learning and
networking portal.Pharma IQ offers a unique multimedia platform for the community
to engage through a series of high level pharma conferences, online events, training
courses, articles, white papers, videos, podcasts, webinars and reports.
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

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Pfizer, GE Healthcare, Novartis Pharma and Boehringer-Ingelheim Pharma Confirm | IDMP Implementation - Impact on Data, Systems and Processes

  • 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 E up to € 300,-w ith our Early Birds ifyou book and pay by 29 M ay 2015! 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 Sponsors: INFOTEHNA, a pioneer in regulated content, publishing and process management software solutions, bolsters global life sciences companies to ensure Quality, Efficacy and Safety of their products. Our unique, Integral by Design myPharma Expert SuiteTM promotes standardization, lightens complexity and enables companies reduce overall product lifecycle manage- ment efforts to achieve sustainable compliance. CUNESOFT GmbH Marsstrasse 4 80335 Munchen Germany www.cunesoft.com PAREXEL GIBRALTA RD, SUITE 200, HASHAM PA 19044 USA www.parexel.com LORENZ Archiv-Systeme GmbH Eschborner Landstraße 75 60489 Frankfurt am Main Germany Alba Lenertz LORENZ Life Sciences Group (www.lorenz.cc) has been developing and marketing software solutions for the Life Sciences market since 1989. LORENZ's solutions are geared specifically for submission assembly, review, publishing, validation and management. LORENZ docuBridge® is the most widely used eCTD submission management system for U.S., European and Japanese formats among many others, and is popular with regulatory agencies and industry alike. With over 400 installations in over 25 countries, LORENZ has a strong worldwide customer base. 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 impacting 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, includingWebLinx InteractiveWebSeminars, 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 specifically for pharmaceu- tical, clinical and biotechnology professionals. www.PharmCast.com brings upto- date information on pharmaceutical patents, FDA, news, jobs and Buyer's Guide to our visitors. It was created and is maintained by pharmaceutical and biotechnology professionals. 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 discov- ery 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 membership to a unique pharmaceutical learning and networking portal.Pharma IQ offers a unique multimedia platform for the community to engage through a series of high level pharma conferences, online events, training courses, articles, white papers, videos, podcasts, webinars and reports. 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