The Medicon Valley Outsourcing Workshop is a one day workshop with focus on learning and networking. During group discussions the participants will use and share own experiences and through discussions learn from each other and improve the knowledge and understanding between sponsors and providers. Moreover, the outsourcing workshop will bring a unique opportunity to interact with peers and build a strong network without the interaction being directly related to sales.
Risk Minimization in outsourcing
Risk-based approaches and technology advances provide an opportunity for more dynamic and proactive approaches. By implementing risk management approaches into the process, you may ensure development and delivery in the most cost and time efficient manner without affecting the quality. This workshop will cover the entire drug development chain and the different challenges that may need risk minimization.
By bringing the industry together to discuss the future of outsourcing, the MVA’s Outsourcing Workshop will seek solutions and best practice sharing.
Date & Time: Tuesday May 13, 2014, 8:30-18:00
Venue: Arne Jacobsens Allé 15-17, 2300 Copenhagen S, Denmark
From the discussions you will:
- Share and discuss your ideas and experiences with peers
- Learn from other leading outsourcing specialists
- Get an improved understanding of outsourcing from both sponsor and provider perspectives
- Expand your network
Participation and cost
MVA members only. 100 seats restricted to MVA member outsourcing experts from biotech, pharma, CROs and CMOs. Due to the limited number of seats, MVA will reserve the right to ensure a proper mix between experts and organizations.
Registration is binding and DKK 750 ex. VAT will be invoiced prior to the workshop. Late cancellation */no-show fee DKK 500 ex VAT.
SIGN UP HERE
Registration ends on May 6, 2014.
* If you cancel after the registration ends, it is considered late cancellation.
|08:30 – 09:00||Registration and Coffee|
|09:00 – 09:15||Welcome & Introduction|
|09:15 – 10:00||Opportunities & Threats of Outsourcing of Non-clinical Development – General Considerations and ExamplesGlobal bio/pharmaceutical companies have been on a desperate mission to turn the productivity of their R&D operations around. To speed up the drug development process and to reduce costs, companies have intensified their efforts to focus on their core competencies and to collaborate with other companies with capabilities, expertise and technology that are not deemed critical to the core business. Outsourcing of non-clinical drug development has several opportunities. However, given the challenge of finding the right co-operation partner and the complexity of the outsourcing process, a number of critical success factors must be considered if a successful outcome is to be ensured. This presentation elaborates on the risks of early-stage non-clinical drug development outsourcing and describes some examples from day-to-day business from the perspective of an outsourcing service provider.|
Anke Domdey, PhD, Partner, invest4biotech ApS
|10:00 – 10:45||Exploring the Benefits of Risk-Adapted Practices for Clinical TrialsRisk-based approaches and technology advances provide an opportunity for more dynamic and proactive approaches to adaptive study design and flexible trial monitoring. By implementing quality risk management approaches into clinical trial oversight, efficiencies can be gained without impacting patient safety and trial integrity.|
This session will explore emerging industry best practices focusing on risk factors with the intent to conduct clinical trials more efficiently and cost-effectively, while ensuring patient safety, data integrity and regulatory compliance.
Brett Villagrand, Senior Director, Product Solutions, Oracle Health Sciences
|10:45 – 11:15||Adaptive designs in clinical trials – an introductionWith drug development costs increasing alternative study designs with the aim of a more rapid and efficient development program has gained attention and adaptive designs has become increasingly popular. Aside of shortening development time and reducing costs, important ethical considerations such as reducing the number of patients treated with placebo are appealing features of more flexible study designs. However, as study design is made less stringent a number of issues emerges and historically some of these issues have made regulatory agencies somewhat skeptical to adaptive designs.|
Anders Nordlund, Senior Biostatistician, Norma
|11:15 – 11:20||Short introduction to MVA Human Clinical Trial Insurance|
/Claus Bang Hansen, General Manager at QBE
|11:20 – 12:00||Coffee and Networking Break|
|12:00 – 13:00||Group Discussion 1|
|13:00 – 14:00||Lunch and Networking Break|
|14:00 – 15:00||Group Discussion 2|
|15:00 – 16:00||Group Discussion 3|
|16:00 – 16:30||Closing Remarks|
|16:30 – 18:00||Networking with tapas and wine|