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CONFERENCE

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eCTD London Summit

eCTD London Summit

Embracing the future with eCTD submissions

20th - 21st May 2010, BSG Conference Centre, London, UK

  1. Background Info
  2. Day 1
  3. Day 2
  4. Partners
  5. Past Papers
  6. Venue Info
  7. Speakers
Associate Sponsors
  • Lorenz Life Sciences
  • NextDocs
Media Partners
  • PharmiWeb.com
  • BIOTECHNOLOGY EUROPE
  • Future Pharmaceuticals
  • InPharm
  • Pharma Connections Worldwide

Background Info

Key Speakers
• Janet Ingram, Director regulatory affairs, Amgen
• Geoff Williams, e-Regulatory Liaison, Roche
• Ulf Klingnäs, Submission Manager, AstraZeneca
• Kay Bross, Director of Member and Vendor programs, SAFE-BioPharma Association
• Brian Di Paolo, Regulatory & Analytical Sciences Biologics CMC, Merck
• Jo English, Director, Regulatory Strategies, Liquent
• Spalt Holger, Senior consultant, Extedo
• Karl-Heinz Loebel, Head of Regulatory Operations, Pharmalex
• Martin Moxham, Managing Director, i-regulatory
• Jasbir Chohan, Associate Director Regulatory Services, Datafarm

eCTD is an interface for the pharmaceutical industry to agency transfer of regulatory information. In July 2009, the EMEA have made it clear that paper and other electronic formats will be an exception to the general e-CTD format recommended for any application. As it is not limited to the transfer of information it also applies to the creation, review, life cycle management and archival of electronic submission. Hence, drug manufacturers must consider new methodologies and adapt their organisation to change.

Visiongain is proud to present its introductory eCTD London Summit, which will be held in London, UK on 20-21 May 2010. This conference will feature keynote addresses, presentations, case studies and interactive discussions from development, approval, implementation and maintenance of eCTD. Please be sure to register your participation amongst the industry's elite for this intensive two-day of learning, networking and exploiting business opportunities.

By attending this conference, you will:
• Discuss emerging trends in electronic submissions in the US & Europe, Filing CTDformatted 
• Identify challenges and benefits of transitioning to eCTD
• Hear the various methods of submitting electronic submissions to global health authorities
• Learn how to manage the lifecycle of an eCTD
• Understand if outsourcing is a rapid, cost-effective option for electronic submissions
• Recognise the vital role of good document management and best business practices in the overall process of preparing the eCTD
• Describe the role of eCTD standards and analysing their impact to the development/delivery process.

Who should attend:

• Document and eRecords Managers
• Standards Implementation Specialists and Associates
• Quality Assurance and Compliance Professionals
• Medical Writers
• IT and Support Personnel
• Contract Researchers & Service Support Providers
• Regulatory Affairs / Operations Professionals
• Academic Researchers
• Regulatory Authority Representatives
• Validation Professionals
• Clinical Data Managers
• Pharmacovigilance Professionals

Target Industry:
Pharmaceutical companies, biopharmaceutical companies, regulatory agencies, publishing, Information Technology, Analysts, Consultants, regulatory 

Day 1

Day 1, Thursday 20th May 2010, London, UK

09:00 Registration and refreshments

09:30 Chairperson’s opening remarks

Geoff Williams
e-Regulatory Liaison
Roche

09:40 Under Discussion at the IRISS Forum: ETICS III
• What is IRISS
• ETICS I
• ETICS II
• ETICS III

John-Paul Smith
Senior Manager Operations Regulatory Affairs
Celgene Europe

10:20 eSubmission management challenges
• History of electronic submission formats
• Breaking down the eCTD complexity & current status
• Understanding the technology: Document Management vs Submission Management

Jason Berning
Professional Services Consultant
Lorenz Life Sciences Group

10:50 Streamlining the regulatory content management process
• Explaining the concept of Intelligent Content and how it will accelerate the regulatory submission process
• Enabling the integration of regulatory software to eliminate process inefficiencies and information silos
• Leverage the information documents carry inside and outside
• Streamline the publishing process by working upstream and start the regulatory process with the document authoring

Jascha Minow
Product Manager
NextDocs Corp
 

11:20 Morning refreshment & networking session

11:40 Requirements for e-submission without paper in Germany
• Compliance with European Guidelines
• Aspects of further developments in regard of common portal use
• Impact of electronic signature

Klaus Menges
Head of Unit
Bfarm

12:20 Efficient multi dossier management
• Concept of mother/child dossiers
• Sample use cases on international dossiers, new EU variation regulation, and drug master file
• Benefits and challenges
• Conclusion and outlook

Spalt Holger
Senior consultant
Extedo

13:00 Lunch

14:00 Hyperlinking and bookmarking

Jasbir Chohan
Associate Director Regulatory Services
Datafarm

14:40 Case Study: CMC variations and module 3
• Industry advantages to eCTD
• e-Platform for CMC data
• Consider new paradigms in CMC dossier content as a result of quality initiatives around the globe
• Submission management
• Resources and compliance
 

Brian Di Paolo
Regulatory & Analytical Sciences Biologics CMC
Merck

15:20 Afternoon refreshments & networking session

15:40 The SAFE-BioPharma interoperable digital identity and signature standard: Fundamental to global R&D and regulatory submissions
• Why the world’s leading biopharmaceutical companies developed an interoperable digital identity and signature standard
• What is the standard
• How is it being used to transform industry’s research, business and regulatory processes to fully electronic
• How the FDA and EMEA support and recognize SAFE-BioPharma digital signatures
• EMEA-SAFE-BioPharma eCTD Pilot; Next Steps
• Moving into the digital 21st century

Kay Bross
Director of Member and Vendor programs
SAFE-BioPharma Association

16:20 Outsourcing in eCTD
• Identifying why pharmaceutical companies are struggling to meet the requirements for electronic submissions
• Deadlines and specification differ from countries to countries
• How outsourcing can benefit pharmaceutical companies for electronic submissions

Kate Wilber
Director of Regulatory Services
ISI Europe

17:00 Chair’s closing remarks

17:10 Networking drinks
Take your discussions further and build new relationships in a relaxed and informal setting  

 

Day 2

Day 2, Friday 21st May 2010, London, UK

09:00 Registration and refreshments 

09:30 Chair’s opening remarks

Martin Moxham
Managing Director
iRegulatory

09:40 The new variations regulation and its impact on electronic submissions
• Changes in european module 1 specifications – new envelope elements
• Worksharing, grouping and annual reporting – impact on e-submissions
• Case study – first eCTD submissions in a worksharing project
• Process optimisation – how to adopt internal workflow to the new challenges
• Software – how systems do support the new options

Karl-Heinz Loebel
Head of Regulatory Operations
Pharmalex

10:20 Regional comparison of regulatory filing requirements
• The advantages of planning and submitting electronic submission prepared with a global focus
• US-specific eCTD requirements
• EU-specific considerations
• Regional variation challenges
• The current acceptance status of eCTD globally
 • Recommendations on tools and procedures you can have in place to better manage your process

Jo English
Director, Regulatory Strategies
Liquent

11:00 Morning refreshment & networking session

11:20 eCTD and NeeS validation criteria
• EU eCTD validation criteria
• Guidance for industry on providing regulatory information in electronic format: NeeS
• How NeeS process changes are manageable?
• Analysing why NeeS is a good stepping stone to eCTD

Martin Moxham
Managing Director
i-regulatory

12:00 Lunch

13:00 The eCTD next major version, RPS and lifecycle management in the future
• What’s next for the eCTD?
• An introduction to RPS
• How might the eCTD NMV support future business processes?
• Lifecycle management using the eCTD NMV for grouped and workshare variations
• Plans for the implementation of the eCTD NMV

Geoff Williams
e-Regulatory Liaison
Roche

13:40 Building a PIM submission
"PIM is a standard for the electronic exchange of product information in the context of marketing authorisation applications. It describes how the required information should be created and validated so that it can be exchanged successfully between applicants and competent authorities. The design of the standard aims to minimise the repetition of information that is included many times in different locations within the documents. Its guiding design principle is to hold any piece of information only once and to allow its use as many times as necessary to create the required documents. It will obviate the need to supply either paper or Microsoft Word documents, as are currently required. The standard utilises XML (Extensible Markup Language) to structure and control the product information being exchanged"
Source: European Medicine Agency

This half day session will guide you through the steps of building a PIM submission using practical examples, hands-on exercises and small group discussion

Learning Objectives:
This session is aimed to be very interactive and to address the following topics:
• Basics of PIM: Process and technical terms
• Understand the buzzword and how they relate to your current way of working, setting the scene, being able to steer the PIM-landscape
The whole process and its steps:
• Migration from Word to XML and harmonization of legacy content
• Working with a PIM-tool with Hands-on exercises
• Translation and translation tools: what are they, what do they do, how are they used in the process

Spalt Holger
Senior consultant
Extedo

*This session includes an afternoon refreshment break

16:40 Chair’s closing remarks

16:50 End of conference 

Partners

Associate Sponsors:

Lorenz Life Sciences
LORENZ is the most established provider of e-regulatory software and services in the world, focused on submission management, labelling and tracking. LORENZ docuBridge® was designed specifi cally to address the challenges facing submission managers in creating, quality control and publishing authorization dossiers (IND, NDA, eCTD, CTD, NeeS) in electronic and / or paper form. LORENZ' solutions foster independence, empowering customers to develop their own processes and maintain control of their own intellectual property. Media Partners: PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For more information please visit www.lorenz.cc/userBridge

NextDocs
NextDocs provides SharePoint 21 CFR Part 11 compliance and a complete set of Quality and Document Management Solutions out-of-the-box in a unified SharePoint environment. NextDocs leverages SharePoint's familiar user interfaces and seamless integration with MS Office to deliver a simpler, better solution for Regulatory, SOPs, Clinical CAPA and more. NextDocs regulatory compliance suite is seamlessly integrated with all leading eCTD tools. Find out more at: www.nextdocs.com

Media Partners:

PharmiWeb.com
PharmiWeb.com is the leading industry-sponsored portal for the pharmaceutical sector. Supported by most of the leading pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news, features, events listings and international jobs to industry professionals across Europe and the US. For further information please email: corporate@pharmiweb.com

BIOTECHNOLOGY EUROPE
BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY WORLD. It is based and located in Warsaw, Poland. Biotechnology World was founded in 2007 to provide the world’s biotech and pharma information and market to make it universally accessible and useful for scientific and business processes. Its first step to fulfilling that mission was building the BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in different channels. BIOTECHNOLOGY EUROPE offers companies completed internet public relations, publication and marketing solutions. One of the main goals of BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to global biotechnology, pharmaceutical and life science activities. For further information please visit www.biotechnology-europe.com

Future Pharmaceuticals
Future Pharmaceuticals has forged powerful relationships with key industry leaders to provide a platform for successful brand recognition, and for senior decision-makers to have the means to procure and plan implementation strategies based on the topics covered. Positioned to be an authoritative resource within top pharma companies as well as small, specialty, and biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into a highly targeted and responsive audience, bridging the gap between the industries' top issues and the solutions top-tier vendors can provide. For further information, please visit www.futurepharmaus.com

InPharm
InPharm is the online platform for exclusive pharmaceutical news, comment, contracts, services, jobs and events and is home to InPharmjobs.com, Pharmafile and Pharmafocus. For further information please visit: www.In-Pharm.com

Pharma Connections Worldwide
Pharma Connections Worldwide® is the leading professional business networking website focused in the Pharmaceutical, Biotechnology and Life Sciences research industry. Our goal is to provide a conduit for delivery of premiere content coupled with the right clientele in order to facilitate business development opportunities among industry professionals responsible for making key decisions in a global marketplace. For further information please visit www.pharmaconnections.com

Enquiries

If you would like more information on the range of sponsorship or exhibition possibilities for visiongain's Immunogenicity Summit, please contact:
Sean Romain LLB, LLM, +44 (0)20 7549 9964
sean.romain@visiongainglobal.com
James Hopkins, +44 (0)20 7549 9974
james.hopkins@visiongain.com
 

Past Papers

Speaker presentations are free to delegates. If you are unable to attend the event, the presentations are published two weeks after the event and are available to purchase.

Venue Info

The visiongain event is to be held at BSG House, London. The address of the venue is:
BSG House, 226-236 City Road, London EC1V 2QY
Click for Google maps

Directions to the venue:
The nearest airports are:

London/Heathrow - LHR
• By train: take the Heathrow Express to Paddington. Change onto the London Underground - Hammersmith & City Line (pink) to King’s Cross, change to the Northern Line (black) to Old Street
• By taxi: Approx. distance: 20 miles / 33KM. Approx. cost: GB£50.00. Approx. time: 1hour 20 mins

London/Gatwick - LGW
• By train: take the Gatwick express to Victoria. Change onto the London Underground - Victoria Line (light blue) to King’s Cross, change to the Northern Line (black) to Old Street.
• By taxi: Approx. distance: 35 miles / 56KM. Approx. cost: GB£60.00. Approx. time: 1hour 20 mins

London City – LCY
• By train: take the Docklands Light Railway to Bank station. Change onto the London Underground - Northern Line (black) to Old Street.
• By taxi: Approx. distance: 6 miles / 9KM. Approx. cost: GB£25.00. Approx. time: 45 mins
Please note these timings and prices are given only as an indication. During peak hours they are subject to increase.
If you wish to pre-arrange travel by taxi and prices with a local taxi company, Addison Lee can be contacted on +44 (0) 20 7387 8888

Eurostar St Pancras International
By train: Change onto the London Underground at King’s Cross – Northern Line (black) to Old Street.
By taxi: Approx. distance: 1.8 miles / 2.89 KM Approx. cost: GB £7.00 Approx. time: 5 minutes
Please note these timings and prices are given only as an indication. During peak hours they are subject to increase.

The nearest major train stations are:
• King’s Cross – take the London Underground - Northern line (black) to Old Street
• Liverpool Street – take the London Underground – Hammersmith & City (pink), Circle (yellow) or Metropolitan lines (maroon) to Moorgate. Change onto the Northern line (black) to Old Street
• Waterloo – take the London Underground – Jubilee line (grey) to London Bridge. Change onto the Northern Line (black) to Old Street

Walking from Old Street station:
Take exit 8 from the station and follow the green line on the floor to Moorfields Eye Hospital, continue on past there for 3-4 minutes, you will see a blue sign on the side of the building saying BSG. This is BSG House, 226-236 City Road.

Venue facilities include:
BSG House features wi-fi internet access and the possibility of using additional meeting rooms. Please contact visiongain for further information.

Local Accommodation:

Here are a list of recommended local hotels
Travelodge London City Road Hotel, 7-12 City Road, London, EC1Y 1AE, Tel: 0871 984 6333, Fax: 0207 628 2503, http://www.travelodge.co.uk/search_and_book/hotel_overview.php?hotel_id=340
Approximately a 10 minute walk to BSG House and close to Old Street tube station and Moorgate which is just 0.5 miles away. The hotel has a breakfast restaurant area and is close to a range of bars and restaurants with attractions including the Globe Theatre and St Pauls Cathedral close by.
Jury’s Inn Islington, 60 Pentonville Road, Islington, London N1 9LA. Tel: +44 (0) 207 282 5500
This hotel is a short journey, or 20-minute walk, away from the conference venue. It is a few minutes walk from Angel tube station and close to King’s Cross, and Euston stations. Also close by is Upper Street (Islington) which has many restaurants, cafes and bars. The rooms offer satellite TV, and internet connections. The hotel has both a bar and restaurant. Standard double room – Single occupancy £98, including breakfast £105, Double occupancy only £98 including breakfast £112. Call reservations on +44 (0) 207 282 5500 and quote Visiongain on booking. This offer is subject to availability.
Hilton London Islington, 53 Upper Street, Islington, London, N1 0UY Tel: +44 (0) 207 354 7700
Probably the furthest from the venue of all of our recommended hotels, but probably the most up-market of the local hotels. Close to Upper Street (Islington) which has plenty of dining and drinking options. Also nearby to Angel tube station and a short cab ride from King’s Cross. The hotel offers wi-fi and a business centre, and a restaurant and bar. Each guest room offers internet access, satellite TV channels and a desk.
London City Holiday Inn Express, 275 Old Street, London, EC1V 9LN Tel: +44 (0) 207 300 4300
Approximately a 10 minute walk to BSG House and close to Old Street tube station, this hotel offers a restaurant and a range of business services, including high-speed internet access in all rooms and the lobby area. The hotel is ideally located for the fashionable bars and restaurants of areas of Hoxton, Shoreditch and Clerkenwell.

The best to see in your host city:

Places to eat:
• Fifteen, 15 Westland Place, N1 7LP T: +44 (0)871 330 1515 – Italian/Fusion
• Carluccio’s Caffe, 305-307 Upper Street, N1 2TU, T: +44 (0) 207 359 8167 – Italian
• Hanoi Café, 98 Kingsland Road, E2 8DP, T: 020 7729 5610 – Vietnamese
• Isarn, 119 Upper Street, N1 1QP, T: 0207 424 5153 – Thai
• Moro, 34-36 Exmouth Market, EC1R 4QE, T: 020 7833 8336 - Spanish

Places to drink:
All of the bars listed do serve food during peak hours
• The Eagle, 2 Shepherdess Walk, City Road, London N1 7LB, T: +44 (0) 20 7553 7681
• Cantaloupe Bar, 35-42 Charlotte Street, London, EC2A 3PB T: +44 (0) 20 7613 4411
• Bavarian Beerhouse, 190 City Road London EC1V 2QH, T: +44 (0) 20 760 80 925
Also Upper Street in Angel Islington, just a short taxi ride away, has a large number of bars and restaurants offering a wide range of cuisine.

If you have the time:
St Pauls Cathedral (1 MI / 1.61 KM )
British Museum (1 MI / 1.61 KM )
Oxford Street * Great for shopping * (1.5 MI / 2.41 KM )
Tower of London (2 MI / 3.22 KM )
Tate Modern (2 MI / 3.22 KM )
London Eye (2 MI / 3.22 KM )
Westminster Abbey (2.5 MI / 4.02 KM )
Houses of Parliament (2.5 MI / 4.02 KM )

Please note: The information contained herein is intended for guidance purposes only. The responsibility to ensure accuracy of the details before visiting remains that of the individual. Visiongain can not be held responsible for any losses resulting from actions taken on the above information.
 

Speakers

Speaker bios: 

  • Brian DiPaolo

    Brian DiPaolo

    Senior Regulatory Coordinator, Biologics CMC

    Merck

    Brian DiPaolo is a Senior Regulatory Coordinator within the Biologics CMC department at Merck in West Point, Pennsylvania. In his 11 years in the pharmaceutical industry, Brian has focused on CMC and regulatory affairs. In his current role, Brian is responsible for the development of regulatory CMC strategies for worldwide development projects within the Merck Biologics organization. He also serves as a departmental expert in eCTD matters.

  • Holger Spalt

    Holger Spalt

    Senior Consultant

    EXTEDO GmbH

    Holger is Senior Consultant at EXTEDO GmbH, a company specialised in advanced life science solutions and associated services, including Submission Management, Labeling, Pharmacovigilance, and Product/Submission Tracking. In his position, he advised many life science companies worldwide introducing regulatory electronic submission technologies from strategy to implementation.

  • Jason Berning

    Jason Berning

    Professional Services Consultant

    LORENZ Life Sciences Ltd.

    Jason Berning is a Professional Services Consultant at LORENZ Life Sciences Ltd. LORENZ has played a pioneering role in the development of Electronic Submission Solutions over the past twenty years and is actively contributing to the expansion of the technological capabilities that are the foundation emerging standards and specifications of data transfer.

  • Kay Bross

    Kay Bross

    Program Director, Member and Vendor Relations

    SAFE-BioPharma Association

    Kay Bross is the Program Director, Member and Vendor Relations for SAFE-BioPharma Association, the non-profit association that created and manages the SAFE-BioPharma® digital identity and digital signature standard for the pharmaceutical and healthcare industries.