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08:00 - 09:00

Registration

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09:00 - 09:10

Opening Remarks

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Showing of Streams
10:55 - 11:25

Networking Break and Morning Coffee

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Showing of Streams
12:30 - 14:00

Networking Lunch

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Showing of Streams
15:45 - 16:15

Coffee and Networking Break

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Showing of Streams
17:20 - 17:40

Closing Remarks

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08:00 - 09:00 60 mins
Registration
09:00 - 09:10 10 mins
Opening Remarks
09:10 - 09:45 35 mins
Info
Global eSubmissions
Telematics Regulatory Landscape and Implementation Feedback
  • Remco Munnik - Regulatory Information Director, Asphalion S.L., Spain
  • An overview of the current regulatory landscape and projected timelines for implementation
  • Feedback on current progress
  • Implications for industry: what is expected and how to achieve this
09:10 - 09:45 35 mins
Info
RIM & IDMP
Telematics Regulatory Landscape and Implementation Feedback
  • Remco Munnik - Regulatory Information Director, Asphalion S.L., Spain
  • An overview of the current regulatory landscape and projected timelines for implementation
  • Feedback on current progress
  • Implications for industry: what is expected and how to achieve this
09:45 - 10:20 35 mins
Info
Global eSubmissions
Best Practice for Successful Implementation of OMS & RMS
  • Dominik Gigli - Senior Manager IDMP Office, Merck, Germany
  • A detailed look at the operation of OMS & RMS implementation processes
  • Discussing the triumphs and hurdles for successful implementation
  • Integration of SPOR into the Application Dataset Management module in CESSP
09:45 - 10:20 35 mins
Info
RIM & IDMP
Best Practice for Successful Implementation of OMS & RMS
  • Dominik Gigli - Senior Manager IDMP Office, Merck, Germany
  • A detailed look at the operation of OMS & RMS implementation processes
  • Discussing the triumphs and hurdles for successful implementation
  • Integration of SPOR into the Application Dataset Management module in CESSP
10:20 - 10:55 35 mins
Info
Global eSubmissions
A Systematic Approach to PMS Preparations
  • Kelly Hnat - Principal, K2 Consulting, USA
  • What is the current outlook for product implementation?
  • Hit the ground running: discussing techniques and methodology for successful integration in the first instance
  • Potential challenges and how best to avoid them
10:20 - 10:55 35 mins
Info
RIM & IDMP
A Systematic Approach to PMS Preparations
  • Kelly Hnat - Principal, K2 Consulting, USA
  • What is the current outlook for product implementation?
  • Hit the ground running: discussing techniques and methodology for successful integration in the first instance
  • Potential challenges and how best to avoid them
10:55 - 11:25 30 mins
Networking Break and Morning Coffee
11:25 - 12:00 35 mins
Info
Global eSubmissions
The IDMP Substance Management System
  • Frits Stulp - IDMP Program Manager, Astellas, The Netherlands
  • An update on the FDA’s progress with the implementation of G-SRS
  • Discussing the status of SMS implementation in the EU
  • Examining the differences between systems and the impact of the HMA endorsement of an EU G-SRS project
11:25 - 12:00 35 mins
Info
RIM & IDMP
The IDMP Substance Management System
  • Frits Stulp - IDMP Program Manager, Astellas, The Netherlands
  • An update on the FDA’s progress with the implementation of G-SRS
  • Discussing the status of SMS implementation in the EU
  • Examining the differences between systems and the impact of the HMA endorsement of an EU G-SRS project
12:00 - 12:30 30 mins
Info
Global eSubmissions
CESSP Essentials: What to Expect from Phase 1
  • Speaker to be Announced, .
  • Discussing the timelines for submission roll out and implications for the future
  • Exploring the interaction of current telematics strategies and CESSP
  • Preparing a system integration plan to control your master data 
12:00 - 12:30 30 mins
Info
RIM & IDMP
CESSP Essentials: What to Expect from Phase 1
  • Speaker to be Announced, .
  • Discussing the timelines for submission roll out and implications for the future
  • Exploring the interaction of current telematics strategies and CESSP
  • Preparing a system integration plan to control your master data 
12:30 - 14:00 90 mins
Networking Lunch
14:00 - 14:35 35 mins
Info
Global eSubmissions
Outlining the Latest Updates from Canada and the Implications for Industry
  • Examining the latest results from the eCTD pilot for CTAs
  • Covering all requirements for 2019
  • Case study on common submission errors and troubleshooting challenges
14:00 - 14:35 35 mins
Info
RIM & IDMP
How eCTD and IDMP Will Work Together
  • Anjana Pindoria - Director Product Strategy, EXTEDO, UK
  • Brexit's impact on parts of the telematics strategy (in Europe). 
  • Looking at how the two worlds should fuse together to form a company’s future RIM programme. 
  • Strategic view of how processes will look in the future when IDMP and eCTD do fuse 
14:35 - 15:10 35 mins
Info
Global eSubmissions
GCC Experiences with eCTD Transitions and Timelines
  • Richard Knowles - Publishing Manager, Global Dossier Management, Ipsen Biopharm Limited, UK
  • Discussing regulation changes across the GCC region
  • Sharing practical experiences of successful submissions
  • Comparing the GCC eCTD submissions process with the EU
14:35 - 15:10 35 mins
Info
RIM & IDMP
Label and Artwork Management Systems: Transitions and Sustainability
  • Bas Van Heijst - Associate Director Regulatory Affairs, , Astellas, Netherlands
  • How to create a fool-proof plan based on market regulations, products, and packaging needs
  • Best practice for preventing costly delays
  • Success stories: improving data quality in your tracking database
15:10 - 15:45 35 mins
Info
Global eSubmissions
Creating a Common Clinical Trials Submission Format
  • Speaker to be Announced, .
  • Is a harmonised Clinical Trial submission format a possibility?
  • Discussing formats and procedures around the globe
  • Identifying roadblocks and planning for them
15:10 - 15:40 30 mins
RIM & IDMP
Spotlight Session
  • Representative from ArisGlobal, ArisGlobal
15:45 - 16:15 30 mins
Coffee and Networking Break
16:15 - 16:45 30 mins
Info
Global eSubmissions
Creating a Global Dossier Plan for Fast-tracking Approvals
  • Olga Alfieri - Director, Global Submission Management, GRO, Eisai, USA
  • Guidelines and updates on global systems
  • Overview and case studies for expedited approvals
  • Regulatory hurdles and creating a plan to overcome them
16:15 - 16:50 35 mins
Info
RIM & IDMP
Digital Transformation of Novartis' Regulatory Processes
  • Wolfgang Schleifer - Service Delivery Lead Regulatory, Novartis, Switzerland
  • Novartis’ strategic digital roadmap to transform Regulatory processes
  • Technology enablers
  • Gain operational efficiency through automation
  • Using data insights and predictive analytics to support better decisions
  • Key takeaways
16:45 - 17:15 30 mins
Info
Global eSubmissions
Panel: Sharing Experiences of Global eCTD Submissions
  • Global eCTD adoption status, trends and v4.0 outlook
  • Sharing experiences of confusion and conflicts from SME and large pharma standpoint
  • Q&A: answering best practice questions
16:50 - 17:20 30 mins
Info
RIM & IDMP
Developing a Robust Data Archiving System
  • Michel Mikhail, Expert in International Regulatory Affairs and Biosimilars, Germany
  • Constructing a flexible long-term data archiving system
  • Reviewing options for maintaining data integrity in the archive system
  • Looking at current automation initiatives and how to use them
17:20 - 17:40 20 mins
Closing Remarks