CRED Regulatory Operations 2017 - handouts

CRED: Introduction to Regulatory Operations 13-14 December 2017, TOPRA Office, London

Day 1 Course Chair: Margaret Gait, Accenture

Time Presentation

Speaker

9.00 9.30 9.40

Registration and Coffee Welcome from TOPRA

TOPRA

Introduction & Course Overview (01-1) • Background into each speaker • Overview of the topics covered over the 2-day course • Attendees introductions • The position of Operations within the product creation chain 10.20 Structuring an Operations Group (Large/Mid & Small Size Pharma) (01-2) • A general introduction and definition of what groups, functions and tasks may sit within different Regulatory Operations groups and how this can vary based on business need and size 11.00 Break 11.30 Resource Management: Virtual Teams & Outsourcing (01-3) • Resource management background • Challenges and advantages of the virtual team • Outsourcing – advantages and disadvantages • Outsourcing – a personal view

Margaret Gait Accenture

Tim Twells Gilead

Margaret Gait Accenture

12.00 Panel Discussion

All

12.30 Global Requirements: (01-4)

Jack Daley Gilead

• What are they? & Ways for managing them

13.00 Lunch

14.00 Global Requirements and How to Manage Them through reuse: (01-5) • Definition of Reuse, Business Case for it and different ways to achieve it • Examples of reuse processes from NDA to MAA to ROW • Global Dossier Publishing Strategies 15:00 Process changes to consider when moving from paper and NeeS to eCTD (01-69)

Tim Twells Gilead

Sarah Tindall

15.30 Break 16.00 The impact of Guidance & Legislation (01-7) • EMA Roadmap • IDMP • Data Transparency • Uploading Submissions • Required Document Formats •

Sarah Tindall

Cross Industry Collaborations EFPIA/ IFPMA/ IRISS

16.30 Questions to the presenters/ discussion of Day 1 sessions

All

17.00 Close of day

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