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Pre-Event Course | 3 - 4 November, 2018
AC Hotel Bella Sky,
Copenhagen

VENDOR OVERSIGHT FOR BIOTECH

Design an effective and compliant oversight strategy

Vendor Oversight for Biotech is a pre-event co-located with BIO-Europe® tailored for the needs of professionals in the process of clinical outsourcing.

Course Overview

Effective oversight of clinical trials is essential for biotech, not only to ensure quality of results, but also to fulfil increasingly stringent regulatory requirements relating to sponsor responsibilities. The smaller size of SME biotech companies as compared to larger entities means that internal experts and departments may not be in place to provide sufficient oversight. This, in addition to budget constraints, can complicate compliance. Further, biotechs seeking a partnering deal may plan to bring products through early-stage clinical trials only before making a deal, therefore influencing their clinical outsourcing strategy. 

Over 2 days and using a mixture of interactive presentations and group discussion, this course offers a specialized view of vendor selection, oversight, management and relationship maintenance for biotech.

Key highlights


Understand the key regulatory obligations
Understand the key regulatory obligations
Align your strategy with R&D needs
Align your strategy with R&D needs
Develop and manage good business relationships
Develop and manage good business relationships

Practical tips for good monitoring
Practical tips for good monitoring

What will you learn?


Understand the regulatory responsibilities of Sponsors in the EU and US
Understand the regulatory responsibilities of Sponsors in the EU and US
Match your outsourcing strategy with the needs of your organisation
Match your outsourcing strategy with the needs of your organisation
Select the correct supplier and begin the relationship well
Select the correct supplier and begin the relationship well

Explore the differences between vendor management and vendor oversight
Explore the differences between vendor management and vendor oversight
Understand various monitoring strategies
Understand various monitoring strategies
Maintain healthy business relationships
Maintain healthy business relationships

Develop your understanding of project management
Develop your understanding of project management
Apply vendor oversight and management to emerging economies
Apply vendor oversight and management to emerging economies