Global Regulatory and Submissions Management in the Pharmaceutical Industry

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Day 1

February 9, 2017

Ice breaker and networking activity: People bingo
Special roundtable session: Let's set personal takeaways
Interactive Session: Regulatory Intelligence: More than a role, an attitude
Global Regulatory Pathways – What – Why – When
EU Regulatory mechanisms to enable early patient access to new medicines. Accelerated assessment, conditional marketing authorization and compassionate use
Best practices for an EU and Global Regulatory Strategy
Case study: Dengue vaccine registration worldwide
A hands-on approach: Emerging markets, regulatory challenges and priorities
Global life cycle management strategy
Open Panel discussion: Implementing global strategy at a local level
Regulatory communications
Panel discussion: Brexit and the potential outcomes from its impact on the regulatory affairs landscape
Catch box session: Day 1 highlights

Day 2

February 10, 2017

Data sharing and transparency
Harmonization: uniform architecture and centralized master data resource
A case study on the double challenge: RIM system replacement and IDMP readiness
Open discussion: Talk with the authorities representatives
Towards enhanced quality, consistency and availability of medicinal product data
Panel discussion: CESP Electronic submissions standardization
Workshop: Mastering eCTD
Evaluating achievements