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Showing of Streams
10:55 - 11:25

Networking Break and Morning Coffee

Showing of Streams
12:55 - 14:25

Networking Lunch

Showing of Streams
Showing of Streams
09:00 - 09:10 10 mins
Main agenda
Chairperson's Remarks
09:00 - 09:10 10 mins
TMF and eTMF
Chairperson's Remarks
09:10 - 09:45 35 mins
Main agenda
Regulatory authority insight: What’s expected from SPOR?
  • Nicolas Varvaeck - ICT Enterprise Architect., AFMPS
more
  • Regulatory feedback on the latest status and implications for industry on SPOR
  • Update regarding SPOR timelines Sharing practical information on what is expected from SPOR
09:10 - 09:40 30 mins
TMF and eTMF
Fully validated TMF vs hybrid: what are the pros and cons of both?
  • Dr Manan Trivedi PhD, TMF Expert/ Consultant.
more
09:40 - 10:10 30 mins
TMF and eTMF
Moving to an eTMF system: Assessing the challenges and opportunities
  • Jane Twitchen - Director, Quality Operations Capability, Global Clinical Operations, Biogen
more
09:45 - 10:20 35 mins
Main agenda
Discussion sharing experiences on how SPOR data can be leveraged in pharmaceutical companies
  • Jörg Stüben - Senior Expert in Global Regulatory Operations, Boehringer Ingelheim Pharma GmbH & Co KG, Germany
more
  • H
10:10 - 10:40 30 mins
TMF and eTMF
CRUK Case study: implementing an eTMF and adopting the DIA TMF reference model
  • Steve Nabarro - Head of Clinical Operations and Data Management, Cancer Research UK
more
  • Why was the decision made to implement an eTMF?
  • Where did the responsibility lie?
  • What resource was needed?
  • How did cost impact decisions made and how was cost justified to senior management?
  • Transition of staff and staff training
  • What was the outcome of the pilot?
  • Lessons learnt
  • Vendor process
10:20 - 10:55 35 mins
Main agenda
Pain Point Panel: Discussion sharing experiences on how SPOR has been implemented
  • Nicolas Varvaeck - ICT Enterprise Architect., AFMPS
  • Jörg Stüben - Senior Expert in Global Regulatory Operations, Boehringer Ingelheim Pharma GmbH & Co KG, Germany
more
  • What are the challenges with implementing SPOR?
  • How to overcome SPOR hurdles?
  • What are the key implications for industry of SPOR implementation?
10:55 - 11:25 30 mins
Networking Break and Morning Coffee
11:25 - 11:55 30 mins
Global eCTD Management
How to speed up your submission to the market
  • Ahmed Abu Eyada - Solution Specialist, Life Sciences, DXC
more
11:25 - 11:55 30 mins
RIM & IDMP Compliance
Integrating QMS and RIM to Achieve Regulatory Operational Excellence
  • Pierre Stanislawski - Product Manager, Ennov
more
  • Maintaining consistency between change controls and regulatory activities
  • Establishing linkages between the QMS and RIM
  • Ensuring regulatory compliance via closed-loop processes
  • Implementing best practices for managing changes globally
11:25 - 11:55 30 mins
TMF and eTMF
Drivers, barriers, and benefits of a unified clinical operatng suite
  • Franciska Darmer - Director for Vault eTMF strategy, Veeva
more
  • What are some of the common challenges during a sponsor/CRO TMF management process?
  • Strategies for working with CROs to ensure close collaboration for standards, oversight and performance monitoring
  • Improving communication between sponsor and CRO: defining the parameters and highlighting where to focus from the outset
  • Lessons learnt
11:55 - 12:25 30 mins
Global eCTD Management
Latest updates and timelines of the EU eSubmission Roadmap
  • Anna Roznovska - Global Regulatory Affairs Director, PRO.MED.CS, Czech Republic
more
  • Exploring the latest timelines of the EU eSubmissions Roadmap
  • Discussing the latest milestones
  • Understanding how far industry have come
11:55 - 12:25 30 mins
RIM & IDMP Compliance
Building a Regulatory Operations Submission Outsourcing Model
  • Henry Quinn - Senior Regulatory Operations Associate, Gilead Sciences Ltd
more
11:55 - 12:25 30 mins
TMF and eTMF
eTMF inspection case study
  • Amer Alghabban - Vice President GxP Quality Assurance, Compliance Training, Karyopharm Therapeutics Inc., Switzerland
more
12:25 - 12:55 30 mins
Global eCTD Management
Roundtables
  • Jaana Pohjonen - Specialist of Record Management and Archives, Quality Manager, FIMEA, Finland
  • Sophia Huang - Site Head, Regulatory Submission Management and Planning Beijing, Bayer
more
12:25 - 12:55 30 mins
RIM & IDMP Compliance
Ensuring regulatory outcomes through NextGen regulatory operations
  • Marty Boom - Global Head of Regulatory and Safety, Navitas Lifesciences
more
12:25 - 12:55 30 mins
TMF and eTMF
Exploring the current environment for outsourcing and assessing the impact on eTMF
  • Martin Hausten - Team Lead Global Document Specialists / Head of Global Document Quality Center, Boehringer Ingelheim
more
  • Adapting to the increased level of outsourcing of clinical activities
  • Examining how an increased level of outsourcing can impact internal processes – how should these processes be redefined?
  • Ensuring accountability and defining oversight to meet regulatory expectations
12:55 - 14:25 90 mins
Networking Lunch
14:25 - 14:55 30 mins
Global eCTD Management
Practically understanding the latest status and timelines of CESSP
  • Alastair Nixon - Director, Global Submission Production, Pharmaceuticals, GlaxoSmithKline Research & Development Limited, UK
more
  • Latest updates to the CESSP system
  • Industry feedback on the timelines for CESSP
  •  Where will CESSP take us
14:25 - 14:55 30 mins
RIM & IDMP Compliance
Case study: Using IDMP to improve data quality for effective RIM systems
  • Jörg Stüben - Senior Expert in Global Regulatory Operations, Boehringer Ingelheim Pharma GmbH & Co KG, Germany
more
  • Importance of data quality
  • Best practice for improving data quality through IDMP
  •  Practical examples of data quality using IDMP
14:25 - 14:55 30 mins
TMF and eTMF
Ensuring global harmonisation with the TMF and defining global processes
  • Amer Alghabban - Vice President GxP Quality Assurance, Compliance Training, Karyopharm Therapeutics Inc., Switzerland
more
14:55 - 15:25 30 mins
Global eCTD Management
Regulatory agency perspective: Feedback, plans and advice for eCTD submissions
  • Jaana Pohjonen - Specialist of Record Management and Archives, Quality Manager, FIMEA, Finland
more

 

  • Feedback on timelines
  • Advice on how to approach eCTD
  • Ensuring a successful eCTD programme incorporating IDMP
14:55 - 15:25 30 mins
RIM & IDMP Compliance
RIM for the sake of RIM - with an IDMP topping.
  • Jacob Ekstrøm - Senior Business Consultant, NNIT
more
14:55 - 15:25 30 mins
TMF and eTMF
Round table session on Actively Managing TMF
  • Bryony B - Clinical Development Scientist - TMF Specialist, GSK
more




15:25 - 15:55 30 mins
Global eCTD Management
Networking and Afternoon Tea
15:25 - 15:55 30 mins
RIM & IDMP Compliance
Networking and Afternoon Tea
15:25 - 15:55 30 mins
TMF and eTMF
Networking and Afternoon Tea
15:55 - 16:25 30 mins
Global eCTD Management
How to structure Policies, SOPs and Processes to improve audit results and increase your assets value.
  • Jack Yeager - CEO, Sylogent, USA
more

- Best practices on how to stylize your Policies and SOPs

- Learn the magical relationships between Regulations, Policies, SOPs, Processes and People.

- How centralized structured Policies and SOPs allow for automated compliance monitors.

- Why each document must include critical Regulation, Policy, SOP and other metadata.

15:55 - 16:25 30 mins
RIM & IDMP Compliance
How Regulatory Information Will Become Part of Your Company’s Big Data Architecture
  • Romuald Braun - Vice President Strategy Life Sciences, AMPLEXOR, Switzerland
more

Holistic Big Data in Regulatory requires combined management of Product Master Data and Regulatory Intelligence, allowing end-to-end automation of processes including configurable interfaces enabling at-the-source data management. Complexity is the main exponential cost driver and the major compliance risk. Reduction of complexity contributes to higher compliance and reduces costs. Such approach can change the paradigm from compliance being cost of doing business and turn compliance into value.

15:55 - 16:25 30 mins
TMF and eTMF
Development of eTMF KPIs for a better CRO partnership
  • Catharine Espanhol - LATAM eTMF Coordinator, Boehringer Ingelheim Brazil
more
16:25 - 16:55 30 mins
Global eCTD Management
Case Study: Understanding the future of Policy 0070
  • Helle Ainsworth - Senior Project Manager, RA Publishing Management, Novo Nordisk A/S, Denmark
more
  • Updates on the success of EMA Policy 0070 and implications for industry
  • Common pitfalls
  • What’s next with Policy 0070?
16:25 - 16:55 30 mins
RIM & IDMP Compliance
Reviewing strategies for data cleaning to ensure high quality data across the business
  • Sheila Elz - RA Master Data Manager, Bayer
more
  • Understanding the importance of data cleaning
  • Exploring the advantages and disadvantages of different methods of data cleaning
  • Avoiding the common pitfalls seen with data cleaning

 

16:25 - 17:00 35 mins
TMF and eTMF
End of day Q+A
16:55 - 17:25 30 mins
Global eCTD Management
Updates on the timelines of eCTD 4.0
  • Leigh Sandwell - Director, Information Management, Pfizer
more
  • Update on eCTD 4.0 timelines
  • Exploring the major challenges introduced in eCTD 4.0
  • How eCTD 4.0 has been affected by Brexit
16:55 - 17:25 30 mins
RIM & IDMP Compliance
eRIMS Data Quality and Reporting project
  • Ulla Larsen - Principal Regulatory Application Specialist, LEO Pharma A/S
more
  • Background
  • Project decision process
  • Concept phase (QC Check, field criticality, interviews, survey, root cause analysis, recommendations)
  • Data Quality Programme (High Priority Projects: 1a Queries & Reports Part 1 – monthly check – data sensitivity, 2 Data correction – periodic theme review, 3 Data Accountability, 4 Processes & Training, 1b Queries and Reports Part 2)
  • Project Plan and Status
  • Learning so far