This is the agenda and brochure for Pharma IQ's upcoming Regulatory Information Management conference on the 2nd and 3rd of March in London. This conference is the only event of its kind to focus solely on the management of information within pharmaceutical companies, to aid regulatory submissions. The event will bring together leading professionals to focus on the regulatory aspects of data and information management.

1. “The First Event of It’s Kind”
Q i d e ce i s c
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MAIN CONFERENCE: 2nD - 3RD MARCH 2011 | PRE-CONFERENCE WORKSHOP DAY: 1St MARCH 2011 | VENUE: MAyFAIR COnFEREnCE CEntRE, LOnDOn
Ensure Regulatory Compliance and Successful Distinguished
Submissions Through Implementing Effective speakers include:
Data Management Strategies and Solutions Alastair Nixon, Director, Submission
Publishing, GlaxoSmithKline
Key reasons to attend: Kevin O’Connell, Head of Dossier
Management, Global Regulatory Affairs,
Reduce new drug development times by UCB Pharma
implementing a centralised data storage system: Remco Munnik, Regulatory Affairs
Discuss which system is right for your business needs Information Manager, Sandoz
David Wheeler, Former Business Relations
Ensure compliance with external submission Manager, MHRA
standards, to ensure successful submissions first time
Mickel Hedemand, Internal Advisor,
Licensing Division, Danish Medicines
Increase your product revenue by reducing time to Agency
market with a streamlined submissions process
Helle Ainsworth, Head of Section,
Submission Management, Lundbeck
Understand the importance of data centralization
and how to roll out a centralised strategy Morwenna Gould, Managing Director,
Morphiris
Hear practical case studies on e-submissions to keep Elizabeth Bricard, Submission
up to date with the latest developments in validation Management & Customer Liaison, Global
and harmonisation with the growing number of Regulatory Operations, Sanofi Aventis
electronic submissions across the industry Susan Genseberger, Head of Global
Regulatory Affairs Operations, Abbott
Improve strategic organisation of submissions in Healthcare
emerging markets and large multi-site submissions Anna Harrington, Director Global
Regulatory Affairs APJEM Russia/CIS Country
Top organisations represented: Expert, GlaxoSmithKline
1. GlaxoSmithKline 5. Danish Medicines Agency Yann Kervevan, EMEA Regulatory
2. UCB Pharma 6. Lundbeck Affairs Operations Manager, Alexion
3. Sanofi Aventis 7. Alexion Pharmaceuticals Pharmaceuticals
4. Sandoz 8. Abbott Healthcare
Eldin Rammell, Managing Director,
Rammell Consulting
Event will discuss: John Farrell, Programme Manager, ISI
• Changing submission standards and the impact on pharmaceutical companies
• Regulatory expectations within eCTD and submission standards Pierre Géruzet, Worldwide Regulatory
• Practical examples of risk- based validation of submission management
• Setting up and maintaining a global regulatory data management system
Affairs, Regulatory Operations Manager,
• Coordinating global submissions in current and emerging markets GlaxoSmithKline Biologicals
• Migrating the backlog of paper to an online electronic format
Alastair Scarlett, Regulatory Operations
Project Manager, UCB Pharma
SPOnSOR: MEDIA PARtnERS:
www.reginfomanagement.com
+44 (0)20 7368 9300 +44 (0)20 7368 9301 ENQUIRE@IQPC.CO.UK

2. Conference Day One: 2nd March 2011
8:30 Registration 14.10 Break-Out Round Table Discussions: Participants will be
able to take part in each of the discussion groups in any
9:00 Pharma IQ Welcome and Chairperson’s order they choose. Each group will spend 20 minutes
Opening Address addressing the topic, sharing ideas, solutions and
David Wheeler, Former Business Relations Manager, MHRA good practice.
EVOLUTION OF REGULATORY STANDARDS Roundtable A
How to Set Up Templates in Order to Make your
9:10 Where are e-Submissions Going? Electronic Submission Work
• mprovement in standards – eCTD NMV, NeeS
I This discussion focuses on preparation and practical
• Improvement in validation – checking tools and planning challenges for submissions with guidance
more relevant parameters from a regulatory perspective
• Improvement in processes – increased efficiency via Chair: Mickel Hedemand, Internal Advisor, Licensing Division,
the CESP (Common European Submission Platform) Danish Medicines Agency
David Wheeler, Former Business Relations Manager, MHRA
Roundtable B
9:50 Changing Submission Standards and the Impact Dossier Review and Compilation: Assessment of
on Pharmaceutical Companies Submission Documents for Content and Presentation
• verview of how regulatory submissions standards
O This discussion focuses on the assessment of trial
have changed in recent years documents for content and presentation and compilation
• Building your global strategy to incorporate the of documents into approved formats
latest submission standard changes Chair: Elizabeth Bricard, Submission Management &
• Outlining common problem areas when adapting Customer Liaison, Global Regulatory Operations, Sanofi Aventis
to new regulatory submissions
• Diversity of approaches to e-submissions across Roundtable C
countries; importance of close collaboration with Handling and Sharing Regulatory Data Within
your regulatory agency an Organisation
• Preparing for the next steps in the changing This discussion focuses on bringing together common
regulatory landscape business process, tools and knowledge bases across an
Elizabeth Bricard, Submission Management & Customer Liaison, organisation to effectively share regulatory information
Global Regulatory Operations, Sanofi Aventis Chair: Remco Munnik, Regulatory Affairs Information Manager,
Sandoz
10:30 Networking Coffee Break
15:10 Networking Coffee Break
ENSURING THE SUCCESS OF YOUR
REGULATORY SUBMISSIONS PROCESS, POLICY AND DATA HARMONISATION
11:00 Making your Submission Reach the Assessor’s Table 15.40 Setting up and Maintaining a Global Regulatory
• ackground for national requirements in
B Data Management System
regulatory submissions • etting up a registration database
S
• Challenges faced by agency reception • Setting up a post authorisation submission database
• Typical errors and how to avoid them (variation planning and tracking tool)
• Compromises in developing standards • Ensuring data compliance
Mickel Hedemand, Internal Advisor, Licensing Division, • Roll-out of database in a global organisation
Danish Medicines Agency Remco Munnik, Regulatory Affairs Information Manager, Sandoz
ROBUST RISK ASSESSMENT STRATEGIES SUBMISSIONS AND HARMONISATION IN
EMERGING MARKETS
11:40 Spotlight on Technology
This session will be hosted by a leading service and 16:20 Coordinating Global Submissions: Emerging Markets
software provider of solutions for regulatory information • Strategising regulatory operations across emerging markets
management. If you are a service provider and would like • Understanding local regulatory policy and environments
to host this session please contact • Selecting development partners with knowledge of
Luke Dash on +44 (0)201 368 9501 submissions in emerging markets
Kevin O’Connell, Head of Dossier Management,
12:20 Networking Lunch Break Global Regulatory Affairs, UCB Pharma
13:30 Working with the PIM Submission Process 17:00 Status of Harmonisation with CTD Requirements
• eveloping a holistic view of information exchange
D within the CIS Region
across the regulatory submission process • anguage requirements for CTD and submissions
L
• Improving information management and the quality to regional authorities
of documentation with information re-use • Timelines of regulatory agencies and the
• Minimising inconsistency, manual input errors, submission process
repetition and delay • Developing an effective working relationship with
• Available technology solutions: benefits and limitations affiliate offices in the CIS region
Morwenna Gould, Managing Director, Morphiris Ltd Anna Harrington, Director Global Regulatory Affairs
APJEM Russia/CIS Country Expert, GlaxoSmithKline
17:40 Chairperson’s Closing Remarks and Close
of Conference Day One
+44 (0)20 7368 9300 +44 (0)20 7368 9301 ENQUIRE@IQPC.CO.UK

3. Conference Day Two: 3rd March 2011
8:30 Registration 14:10 Break-Out Round Table Discussions: Participants will be
able to take part in each of the discussion groups in any
9:00 Pharma IQ Welcome and Chairperson’s order they choose. Each group will spend 20 minutes
Opening Address addressing the topic, sharing ideas, solutions and
Mickel Hedemand, Internal Advisor, Licensing Division, good practice.
Danish Medicines Agency
Roundtable A
OPTIMISING REGULATORY SUBMISSIONS Strategies Towards Gaining Market Access
Through Successful Submissions
9:10 Effective Planning for Submissions This discussion provides the opportunity to explore how to
• dentifying planning needs
I ensure a robust and successful submissions strategy that
• Implementing databases can enhance a brand profile in existing and emerging markets
• Bringing together common business process, Chair: Alastair Nixon, Director, Submission Publishing,
tools and knowledge bases GlaxoSmithKline
• Establishing processes for knowledge transfer to
facilitate submissions Roundtable B
Susan Genseberger, Head of Global Regulatory Affairs Major Challenges in Changing from the Paper
Operations, Abbott Healthcare World to the Electronic World
This discussion highlights solutions to the practical
9:50 Harmonisation of eCTD and Nees Validation Criteria obstacles in migrating from traditional to technology
• The impact of the growing number of eCTD submissions focused submission protocols and standards
on the description and interpretation of the validation criteria Chair: Helle Ainsworth, Head of Section,
• eCTD validation rules and consequences for Submission Management, Lundbeck
future submissions
• Implementation of new validation criteria Roundtable C
Alastair Nixon, Director, Submission Publishing, GlaxoSmithKline Sharing Information on Regulatory Intelligence
Across an Organisation
10:30 Networking Coffee Break This discussion addresses the practical challenges in
disseminating regulatory intelligence and information
11:00 Making the Transition from Paper Based to amongst regulatory affairs, operations and submissions
Electronic Submissions professionals in order to continuously improve awareness
• oll-out and implementation of eCTD
R of trends and developments
• Transferring legacy products to eCTD format Chair: Susan Genseberger, Head of Global Regulatory
• Ensuring company compliance and developing process Affairs Operations, Abbott Healthcare
for metadata and lifecycle management
• Developing submission readiness in an 15:10 Networking Coffee Break
adapting environment
• Overcoming the challenge of delivering REGULATORY INTELLIGENCE AND STRATEGY
different submission formats
Helle Ainsworth, Head of Section, Submission Management, 15:40 Panel Discussion: Improving Regulatory
Lundbeck Intelligence to Optimise the Submissions Process
• ollating information on current and future
C
11:40 Challenges in eCTD Implementation and regulatory trends
Electronic Submissions • Processing regulatory intelligence
• onverting and assembling files
C • Effectively sharing information on regulatory intelligence
• Quality control, content and technical validation across an organisation
of eCTD submissions Panellists include:
• Managing submission timelines and Yann Kervevan, EMEA Regulatory Affairs Operations
regulatory expectations Manager, Alexion Pharmaceuticals
• Overcoming coding challenges when transferring Alastair Nixon, Director, Submission Publishing,
data from eCTD to regulatory platforms GlaxoSmithKline
Yann Kervevan, EMEA Regulatory Affairs Operations Manager,
Kevin O’Connell, Head of Dossier Management,
Alexion Pharmaceuticals
Global Regulatory Affairs, UCB Pharma
12:20 Networking Lunch Break
ELECTRONIC DOCUMENT MANAGEMENT
RECORDS AND DATA MANAGEMENT SYSTEMS CASE STUDIES
13:30 Assessing the Pitfalls and Opportunities of 16:20 Implementation of a New eDMS for Regulatory
Centralising your Data Management System Operations – The GSK Biologicals Experience
• nderstanding the need to manage submissions
U • Ensuring efficiency and accuracy of electronic workflow
• Managing market pressures with an holistic approach • Enabling easier circulation and approval of documents
to regulatory information management • Delivering time, cost, and space saving solutions,
• Responding promptly and completely to regulators while maintaining data security
• Developing a centralised, integrated solution to Pierre Géruzet, Worldwide Regulatory Affairs, Regulatory
incorporate all aspects of the product portfolio, from Operations Manager, GlaxoSmithKline Biologicals
clinical and R&D right through to resource management
and planning 17:00 EDMS Management, Administration and Training
John Farrell, Programme Manager, ISI • Managing information for globalisation and innovation
• Document security models
• Identifying and utilising the appropriate tools from
available resources
Alastair Scarlett, Regulatory Operations Project Manager,
UCB Pharma
17:40 Chairperson’s Closing Remarks and Close of
Conference Day Two
+44 (0)20 7368 9300 +44 (0)20 7368 9301 ENQUIRE@IQPC.CO.UK

4. Pre-conference Workshop Day: 1st March 2011
Workshop A:
Building a Robust Trial Master File (TMF) to Facilitate Regulatory Submissions
08.30 – 12.30
This workshop focuses on the theme of trial master files from a clinical operations perspective. Delegates will benefit from guidance on
important challenges as they pertain to regulatory activities, in particular:
• How to build a compliant TMF process
• How the different needs of clinical operations and regulatory affairs can be met by a single TMF system
• Process-based approach to repository metadata models
Workshop host: Eldin Rammell, Managing Director, Rammell Consulting
Workshop B:
Managing a PIM Submission with the Light Authoring Tool (LAT)
14.00 – 17.00
This workshop is focused on supporting your application of PIM principles to regulatory submissions and developing your skills in using
the Light Authoring Tool (LAT)
• Creating PIM submissions
• Realising the benefits of the LAT
• Likely future developments in PIM
For more information on how to facilitate or sponsor this workshop
please contact Luke Dash at enquire@iqpc.co.uk
What Does Pharma IQ’s Pharmaceutical Join the
Regulatory Information Management Offer? Pharma IQ community
This conference provides a unique platform for drug Become a member of Pharma IQ and receive complimentary
developers, national regulators and service providers to share access to resources that will keep you at the forefront of
good practice and successful strategies to help get products industry change. You will receive access to our growing
to market more quickly. Professionals across key functions library of multi-media presentations from industry leaders, an
in regulatory affairs and operations will get to grips with the email newsletter updating you on new content that has been
practical challenges of managing, sharing and submitting added, free aggregated news feed from over 1000 global
regulatory information for faster, accurate and successful news sources tracking your industry and special member only
submissions, across the EMEA region and in emerging markets. discounts on events.
Through a mixture of case studies and strategic presentations, For more information and to become a member,
this agenda will provide solutions based on a range of proven visit www.pharma-iq.com
and successfully implemented submission and information
management policies to help you enhance your current
processes and overcome your regulatory hurdles.
For sponsorship and exhibition opportunities contact us on
+44 (0) 207 368 9300 or Sponsorship@iqpc.co.uk
Current Sponsor: Media Partners:
+44 (0)20 7368 9300 +44 (0)20 7368 9301 ENQUIRE@IQPC.CO.UK

5. Who Should Attend Elizabeth Bricard
Over 30 years in the Pharmaceutical Industry based in France,
Directors, senior managers and managers from the following starting with Roussel Uclaf through Hoechst Marion Roussel, Aventis
and today Sanofi-aventis. Working in development for the last 20
areas within pharmaceutical manufacturers and biotech years with experience in Preclinical (translation and report/dossier
companies, clinical researchers and service providers: management), Clinical Pharmacology (global coordination focusing mainly
on studies and document management) and finally Regulatory Operations
From Pharmaceutical and Biotech Manufacturers: since 2005. Involved from mid 1990s in the setting up and management of
• Regulatory Affairs eDMS systems in the various organizations. Currently Submission Manager
• Regulatory Data Management and Customer Liaison for European, Asia-Pacific and Intercontinental regions.
• Regulatory Information Management
• Regulatory Operations Remco Munnik
• Information Technology Remco Munnik has a Bachelor degree in a study of Management,
• Clinical Operations Economics & Law. In 1999 he started working within the European
Registration department of Sandoz (RCC-EU) and became the
From Regulatory Bodies: responsible manager for the administration group. In this function Remco
• Chairperson was responsible for planning the submissions of MRP/RUP/DCP’s, variations
and renewals; as well as establishing the internal processes and training
• Director General e-Regulatory of people.
• Regulatory Liaison
Since beginning of 2007, Remco changed to the function of Regulatory
Affairs Information Manager.
In this function he is responsible for tracking all global developments on
electronic submissions for Sandoz, as well acting as project manager for
Why Now? two SAP databases for the tracking of registrations and variations.
Remco is also acting as Chairman of the EGA (European Generics
The need for ever evolving knowledge in the area of R&D Association) working group for eCTD.
for increased disease, biology and genetic demands
means that pharmaceutical companies on average spend
10-20% of their revenues in R&D. In addition, the length Susan Genseberger
Susan obtained a MSc in Chemistry from the University of
of product market exclusivity, competitive pressure and Amsterdam in 1995.
rigorous regulatory procedures requires drug developers She started her career in Regulatory Affairs at Yamanouchi
to carefully examine costs to increase the chances of a (nowadays Astellas) where she was responsible for updating &
good return on investment. This pressures makes it crucial upgrading the CMC dossiers and the submission & approval of these dossiers
for regulatory information to be managed effectively with in European & non-European countries.
strategies in place to share information between national She also took care of the distribution regarding regulatory information.
affiliates, drug development partners and regulatory In 2002 she changed the European headquarters from Yamanouchi for
authorities. Ensuring this process is as simple and seamless a national branch office from Aventis. She became responsible for the
regulatory activities of about fifty products (variations, PSURs, SmPC updates,
as possible enables quicker submissions and translates into PIL, control of packaging material, review of promotional material) and new
significant costs savings. insulin registrations in The Netherlands. When Aventis became Sanofi-Aventis,
Susan changed position and became responsible for the review & approval
In light of this and with feedback from the market, Pharma of all promotional materials & activities and the training of the employees in
IQ’s has launched its inaugural Regulatory Information commercial legislation.
Management Conference. This conference is the only event In 2005 Susan moved to Solvay Pharmaceuticals and was appointed a
of its kind in the UK to focus solely on the management of liaison function between the chemical and pharmaceutical development
department in Weesp and the CMC regulatory affairs departments
information within pharmaceutical companies in order to
in Germany and the US. Nowadays Susan is responsible for the global
aid regulatory submissions. The event will bring together coordination of activities regarding regulatory intelligence, standard
leading professionals to focus on the regulatory aspects of operating procedures, training and planning for the regulatory affairs
data and information management. department in Abbott (former Solvay).
Morwenna Gould
is a managing director of Morphiris, a firm specialising in
Networking at the Event providing product information management consultancy to the
pharmaceutical industry and regulators.
Gain unparalleled networking opportunities, with a large
She has extensive experience implementing the European Medicines
number of senior decision makers through discussion sessions, Agency’s (EMA) PIM standard and has provided consultancy to the
EMA, in addition to pharmaceutical companies, to aid them with their
extended breaks, case study presentations and critical implementations of PIM.
regulatory updates. You will spend crucial face-to-face time
with industry experts and position your company as a leading
innovator in the oncology development arena. Yann Kervevan
Yann is a Pharmacist graduated from the Faculty of Pharmacy in
Lyon, France.
He started his carrier in Regulatory Affairs where he was in charge
of registrations activities (Servier, GSK, Stragen Pharma) and rapidly
Speaker Biogs moved to Regulatory Operations position in Sanofi-Pasteur MSD. He joined
Extedo GmbH in 2008 where he worked as a Project Manager for Installation,
Mickel Hedemand Training and follow-up of various e-tools both in companies and National
Mickel Hedemand. M.Sc. in Engineering (production) at Aalborg competent authorities. He is now working for Alexion Pharma International in
University in 2004. Certified SAP Consultant (mySAP Supply Lausanne as a Regulator Operations Manager (since June ’10).”
Chain Management, Procurement) in 2005 and worked as SAP
Consultant for ASA-Mentor/WM data A/S until 2007. Since then
he has been Internal Adviser at the Danish Medicines Agency (DKMA), Eldin Rammell
Licensing Division comma facilitating and optimising internal processes, Eldin has over 17 years industry experience prior to becoming a consultant.
workflow and extracting case and product related data. A key figure in In 2003, Eldin left Pfizer as Associate Director of Records Management and,
DKMA’s preparations to receive and archive electronic-only submissions. after a brief journey as a restaurateur, established Rammell Consulting to help
Implementation of the common European review system (EURS) at DKMA. companies and organisations improve their records management processes.
Technical validation of electronic submissions.
He has been a guest lecturer at City University, London and has published
articles in the GCP Journal and Clinical Researcher. He is Secretary and past-
President of the Good Clinical Practice Records Managers Association (GCP-
RMA).
+44 (0)20 7368 9300 +44 (0)20 7368 9301 ENQUIRE@IQPC.CO.UK

6. 5 WAYS TO REGISTER
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2nD - 3RD MARCH 2011 +44 (0)20 7368 9300
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