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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
Case study: Practically implementing SPOR as a step toward IDMP compliance
  • Jakob Juul Rasmussen, Independent Consultant, Denmark
more
  • How SPOR should be integrated into the entire regulatory process
  • Using SPOR to improve data management
  • Ensuring effective use of SPOR vocabularies
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
  • Jakob Juul Rasmussen, Independent Consultant, Denmark
  • 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
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
11:25 - 11:55 30 mins
RIM & IDMP Compliance
Presentation from Ennov
11:25 - 11:55 30 mins
TMF and eTMF
Accountable oversight: what are the regulatory expectations?
  • Lori Julia Ridge CCRC-CRA - Clinical Project Associate & eTMF Specialist, Mylan
more
  • Defining regulatory authority definition of accountable oversight
  • How should oversight be documented in the TMF? Is this being demonstrated to the regulatory authorities?
  •  Understanding accountable oversight from an operational
11:55 - 12:25 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
11:55 - 12:25 30 mins
RIM & IDMP Compliance
Best practice to ensure a successful RIM system with high data quality
more
  • Feedback on how to best keep RIM systems updated
  • How to overcome challenges of updating data
  • Best practices for maintaining good quality data
11:55 - 12:25 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
12:25 - 12:55 30 mins
Global eCTD Management
Understanding the success of submissions via CESSP so far
more
  • How many entries have there been?
  • What have the hurdles been so far?
  • What ways can we potential to improve CESSP?
  • Exploring the quality of submissions so far
12:25 - 12:55 30 mins
RIM & IDMP Compliance
Spotlight session from Navaitas
12:25 - 12:55 30 mins
TMF and eTMF
Sponsor and CRO Dual dialogue: Ensuring communication throughout the TMF management plan process
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
12:55 - 14:25 90 mins
Networking Lunch
14:25 - 14:55 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
14:25 - 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
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.

14:55 - 15:25 30 mins
RIM & IDMP Compliance
Spotlight NNIT
  • 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
Case Study: Understanding the future of Policy 0070
  • Helle Ainsworth - Senior Project Manager, RA Publishing Management, Novo Nordisk A/S, Denmark
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
15:55 - 16:25 30 mins
RIM & IDMP Compliance
Presentation from Amplexor
15:55 - 16:25 30 mins
TMF and eTMF
eTMF and interoperability: strategies for success
16:25 - 16:55 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
16:25 - 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
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