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Informa
08:00 - 09:00

Registration

Showing of Streams
10:20 - 10:50

Networking Break

Showing of Streams
12:35 - 13:50

Networking Lunch

Showing of Streams
15:35 - 16:05

Networking and Afternoon Tea

Showing of Streams
17:15 - 18:15

Networking Drinks

08:00 - 09:00 60 mins
Registration
09:00 - 09:10 10 mins
Global eCTD Management
Remarks from Chair
09:00 - 09:10 10 mins
RIM & IDMP Compliance
Remarks from Chair
09:00 - 09:10 10 mins
TMF and eTMF
Remarks from Chair
09:10 - 09:45 35 mins
Global eCTD Management
Case study: Understanding best practice for ECTD submissions in China
  • Sophia Huang - Site Head, Regulatory Submission Management and Planning Beijing, Bayer
more

Discussing the timelines for eCTD implementation in China

Exploring the remaining challenges for the implementation of eCTD in China

Comparing requirements and expectations in China with EU eCTD submissions

09:10 - 09:45 35 mins
RIM & IDMP Compliance
Preparing for IDMP implementation irrespective of the delay
  • Andrea Herrmann - Head of IDMP Office – GRA Operations, Merck
more
  • How SMEs should be preparing
  • The importance for SMEs to not stop their IDMP programme
  • Step by step guide to successful handling of IDMP timelines for SMEs Feedback from SMEs on how they handle their data
  • Overcoming common challenges for handling data as an SME
09:10 - 09:45 35 mins
TMF and eTMF
Understanding the current regulatory requirements for Trial Master Files and Electronic Trial Master Files
  • Philip Møller - Medi­cines Con­trol & In­spec­tion, Danish Medicines Agency
more
09:45 - 10:20 35 mins
Global eCTD Management
Latest progress towards ECTD submissions in Canada, including an update on the ECTD pilot for Clinical Trial Applications (CTAs)
  • Joel Raymond - Manager, Health Canada
more
  • Explaining upcoming 2018 requirements for eCTD in Canada
  • Update on the success or failures of the CTA eCTD pilot in Canada
  • Where next for the CTA pilot?
09:45 - 10:20 35 mins
RIM & IDMP Compliance
EU regulatory authority perspective on IDMP: where we are, where are we going?
  • Thomas Balzer - Member of the IDMP Task Force, Co-Chair of the European Data Network Board and Project Manager, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM), Germany
more
09:45 - 10:20 35 mins
TMF and eTMF
Industry feedback: Strategies to ensure the eTMF/TMF is inspection ready
  • Timothy Rafferty - eTMF Metrics and Data Quality Manager, Roche
more
  • TMF best practice: What will the inspectors be looking for?
  • Ensuring and demonstrating compliance with good documentation practice
  • How regularly would inspections take place?
  • What do incomplete TMFs look like?
10:20 - 10:50 30 mins
Networking Break
10:50 - 11:25 35 mins
Global eCTD Management
Latest updates and progress for eCTD in the GCC
  • Muna Al Saidi - Pharmacist, Ministry of Oman
more
  • Updates from GCC on the success of eCTD
  • What we can expect from eCTD in the GCC?
  • Sharing experiences of successfully submitting eCTD in GCC
  • What programmes are the GCC using for medical devices?
10:50 - 11:25 35 mins
RIM & IDMP Compliance
ISO IDMP and the impact on RIM and daily Regulatory Operations
  • Remco Munnik - Regulatory Information Director, Asphalion S.L., Spain
more
  • ISO IDMP compliance, burden translated into a benefit
  • Exploring how IDMP can ensure efficacy gain in your business
  • Assessing the overall success of implementing IDMP model into your company
  • Impact of IDMP on other eSubmission tools
10:50 - 11:25 35 mins
TMF and eTMF
Spotlight from Montrium
11:25 - 12:00 35 mins
Global eCTD Management
Updates on the eCTD programme in South Africa
  • Estelle Taute - Director: Operations & Administration, Medicines Control Council, South Africa
more
  • The success of the eCTD programme in South Africa
  • Overcoming hurdles that have been overcome during the first year of eCTD in South Africa
  • Explaining the transition phase to eCTD
11:25 - 12:00 35 mins
RIM & IDMP Compliance
Case study: Successfully creating and implementing a RIM system
  • Thomas Wimmer - Senior Manager Global Regulatory Operations, Alexion Pharmaceuticals
more
  • Best practice for creating a new RIM system
  • A step by step guide to successful RIM implementation
  • Understanding how teams should be running a RIM project after implementation 
11:25 - 12:00 35 mins
TMF and eTMF
eTMF inspection case study
more
  • Preparing for the inspection – what needed to be taken into account and what steps were taken?
  • What strategies were undertaken to ensure documentation was maintained prior to inspection?
  • What did the regulator/inspector want to see?
  • Lessons learnt
12:00 - 12:35 35 mins
Global eCTD Management
eSubmission Evolution: digital paper to structured data
  • Jared Lantzy - Manager, Global Regulatory Agencies and Processes, LORENZ Life Sciences
more

o Explore regulatory authority plans to request structured data eSubmissions

o Explain how Regulatory Authorities process and use structured data

o Discuss the increasing link between eSubmission management and RIM systems

12:00 - 12:35 35 mins
RIM & IDMP Compliance
Automating Regulatory Maintenance – RIM Optimization
  • Representative From Cunesoft, Cunesoft
more

· Determine the potential of automating regulatory operations maintenance processes

· Discussing the use case: End to End submissions management

· Reviewing cost savings potentials, while maintaining process quality and flexibility


12:00 - 12:35 35 mins
TMF and eTMF
Managing an Active TMF: Tips for eTMF Management
  • Patricia Santos-Serrao - Director, Clinical Product Strategy Company, MasterControl
more

Value of managing an active TMF, not just a final TMF

Reducing the risks of managing an active TMF

Tips for using content rights, status and metadata

12:35 - 13:50 75 mins
Networking Lunch
13:50 - 14:25 35 mins
Global eCTD Management
Case Study for preparation of switch to mandatory eCTD format for EU Nationally Authorised Products (NAPs)
  • Bernd Misselwitz - Director, Regional Head of Regulatory Submission, Bayer
more
13:50 - 14:25 35 mins
RIM & IDMP Compliance
Exploring what the future holds for RIM
  • Matthew Neal - Senior Director, Product Management, Regulatory and Clinical Soultions, PAREXEL
more

•Analysing the potential for commercial growth using your RIM system

• Discussing new and emerging technologies for RIM and the benefits for industry

• Reviewing what industry should be thinking about now for RIM, the next key challenges and when to prepare

13:50 - 14:25 35 mins
TMF and eTMF
Bridging the Gap Between Clinical Systems
  • Kaylin Tribble. - Clinical Product Manager, arivis
more

Today’s Pharmaceutical companies are faced with the challenge of bringing drugs to the market faster while also reducing drug development costs by maximizing efficiencies. In order for Pharmaceutical companies to continue evolving into more effective entities in the digital world, software synchronization is essential. This has encouraged collaboration amongst software vendors to offer Sponsors new and innovative solutions that will assist them with this process. However, many Sponsors are still unaware of what is entailed in the integration of clinical systems such as electronic Trial Master Files (eTMF), Clinical Trail Management Systems (CTMS), and Electronic Data Capture (EDC). In order to offer some insight into this process, a case study was prepared to highlight several software vendors with working integrations. They were evaluated by comparing the cost, time, and benefits associated with integrating document management systems, CTMS, and others.

14:25 - 15:00 35 mins
Global eCTD Management
Panel discussion: The Future of ECTD
  • Alastair Nixon - Director, Global Submission Production, Pharmaceuticals, GlaxoSmithKline Research & Development Limited, UK
  • Mickel Hedemand - Special Adviser, Danish Medicines Agency
more
  • Sharing visions for formats, submission routes/media, repositories, metadata (including Afs), SmPC handling (submitting, archiving, presentation for users) in Europe
14:25 - 15:00 35 mins
RIM & IDMP Compliance
Ensuring you are updating your RIM system successfully
  • Segren Bernard - Associate Director, Regulatory Information Management, Norgine
  • Hardik Mistry - IDMP Manager, Norgine
more
14:25 - 15:00 35 mins
TMF and eTMF
A mock inspection
  • Philip Møller - Medi­cines Con­trol & In­spec­tion, Danish Medicines Agency
more

To mix up the format, we’ll be hosting a mock inspection, giving you an opportunity to have a run through of how a TMF inspection would go, and what areas you need to improve and work on to ensure you succeed in your next inspection.

15:00 - 15:35 35 mins
Global eCTD Management
eCTD around the world, are you ready for a global evolution?
  • Anjana Pindoria - Director Product Strategy, EXTEDO
more
15:00 - 15:35 35 mins
RIM & IDMP Compliance
Automation in Regulatory – Excited or Scared: a near reality or distant dream?
  • David Scanlon - Senior Director Regulatory Strategy, Arisglobal
more
  • The presentation will explore real productivity gains from automation in other settings to identify applicability for regulatory professionals.
  • Looking at Regulatory Information Systems in the context of E-2-E Processes across the R&D Value chain shows the opportunities for Regulatory Informatics and Analytics and Automation. Getting the systems, data and processes working in harmony leads to possibilities in automation.
  • The presentation will look at the evolution and future possibilities for Regulatory Information Management, and how new automation technologies may drive quality improvements while reducing costs. This will be presented in the context of challenging constraints around the speed of regulatory changes globally.
15:00 - 15:35 35 mins
TMF and eTMF
Moving towards a more active management of the TMF and effectively leveraging the data
  • Joanne Malia - Associate Director of Clinical Document Management, Regeneron
more
  • Assessing the benefits of having a high quality, complete and timely TMF
  • Who has full responsibility for keeping the TMF? Sponsors, CRO? How are they spread geographically?
15:35 - 16:05 30 mins
Networking and Afternoon Tea
16:05 - 16:40 35 mins
Main agenda
Discussing the impact of Brexit on the EMA and Industry’s regulatory projects
  • Paul Ranson - Consultant, Morgan, Lewis and Bockius
more
  • The impact on IDMP timelines
  • Impact on eCTD programmes and the implications for industry
  • Can we know how to prepare for Brexit? Understanding how Brexit will impact EMA projects
16:05 - 16:40 35 mins
TMF and eTMF
Discussing the impact of Brexit on the EMA and Industry’s regulatory projects
  • Paul Ranson - Consultant, Morgan, Lewis and Bockius
more
  • The impact on IDMP timelines
  • Impact on eCTD programmes and the implications for industry
  • Can we know how to prepare for Brexit? Understanding how Brexit will impact EMA projects
16:40 - 17:15 35 mins
Main agenda
Panel discussion (with live polling): The impact of the everchanging regulatory landscape to eCTD and IDMP including Brexit
  • David Jefferys - Senior Vice President, UK
  • Jörg Stüben - Senior Expert in Global Regulatory Operations, Boehringer Ingelheim Pharma GmbH & Co KG, Germany
  • Paul Ranson - Consultant, Morgan, Lewis and Bockius
more
  • How will regulatory changes, including Brexit and changing EMA priorities, affect eCTD and RIM in the long run?
  • How can we prepare for the changing landscape?
  • What are the impacts of being unprepared? Live Polling: attendees are invited to vote on whether they will be impacted by regulatory change
16:40 - 17:15 35 mins
TMF and eTMF
Panel discussion (with live polling): The impact of the everchanging regulatory landscape to eCTD and IDMP including Brexit
  • David Jefferys - Senior Vice President, UK
  • Jörg Stüben - Senior Expert in Global Regulatory Operations, Boehringer Ingelheim Pharma GmbH & Co KG, Germany
  • Paul Ranson - Consultant, Morgan, Lewis and Bockius
more
  • How will regulatory changes, including Brexit and changing EMA priorities, affect eCTD and RIM in the long run?
  • How can we prepare for the changing landscape?
  • What are the impacts of being unprepared? Live Polling: attendees are invited to vote on whether they will be impacted by regulatory change
17:15 - 18:15 60 mins
Networking Drinks