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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
16:40 - 17:40

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
IDMP Timelines: where we are, where are we going?
  • Remco Munnik - Regulatory Information Director, Asphalion S.L., Spain
more
09:45 - 10:20 35 mins
TMF and eTMF
Industry feedback: Analytics to ensure the eTMF is inspection ready
  • Timothy Rafferty - eTMF Metrics and Data Quality Manager, Roche
more
  • What will the inspectors be looking for?
  • Using metrics to see what's happening
  • Highlighting problem areas
  • Converting numbers to actions
  • Predicting issues with analytics
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
eTMF: The Key to Continuous Inspection Readiness in Clinical Trials
  • Paul Fenton - President & CEO, Montrium
more

Regulatory authority expectations regarding trial master files are evolving and inspection readiness when using eTMF is on the forefront of most sponsors minds. Achieving TMF inspection readiness can be challenging without the right tools and processes in place. Teams still scramble to locate and organize trial master file content, and prepare effectively for regulatory inspections, often requiring late nights and a great deal of hunting to get ready. This additional pressure on clinical teams and increased risk of issues during inspection could be avoided, through proper planning and use of technology.

In our upcoming complimentary webinar we’ll be exploring how sponsors and CROs can implement a proactive TMF inspection readiness methodology by looking both at your process and the technology you leverage to help you manage TMF content.

Our webinar will focus on:

  • Evolving expectations of the regulators
  • TMF planning to ensure timeliness
  • Managing inspections with an eTMF
  • Centralizing content through technology
  • Challenges of calculating TMF completeness
  • Features that your eTMF needs to facilitate inspections
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
The Alexion RIM Path Big Bang vs. Phased Approach
  • 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
Six Sigma Implementation to evaluate TMF staff performance
  • Catharine Espanhol - LATAM eTMF Coordinator, Boehringer Ingelheim Brazil
more
  • Using of Measurement Systems Analysis (MSA) to validate the QC process
  • Detecting and solving internal variation work in a TMF
  • Analyzing the use of Six Sigma Tools to standardize the TMF process
  • Implementing actions to avoid internal variation caused by employees
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
  • Jim Nichols - COO, Cunesoft GmbH
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, ex- 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 - 17:40 60 mins
Networking Drinks