13 - 14 November, 2019 | Hilton Munich City, Munich, Germany
Main Conference Day 2
8:30 am - 9:00 am Registration and Welcome Coffee
9:00 am - 9:10 am Chairman's Recap of Day One
9:10 am - 9:50 am Interactive Working Group
- Discuss the aims/objectives and process for White Paper development
- What do want to say, to who, how, by when and how?
- Next steps/plan of action
9:50 am - 10:30 am TOWARDS THE VISUALISATION, MONITORING AND CONTROL OF MULTIVARIATE PHARMACEUTICAL PROCESSES
- Discuss multivariate data visualisation and look towards Pharmaceutical Lean Six Sigma
- Explore Pharma 4.0 and it’s applications such as virtual sensors, automation and quality predictive control
- Extract information from the data to ensure the manufacture of consistently high quality product and obtain early warning of changes in process behaviour, process faults and non-conforming operation
Julian Morris
Technical DirectorCentre for Process Analytics and Control Technology (CPACT)
10:30 am - 11:00 am Networking Coffee Break
11:00 am - 12:00 pm START-UP SPOTLIGHT:
With the need for efficiency to utilise data at an all time high, there’s a huge boom within the start-up space, offering innovative solutions to effectively meet these requirements. This session is designed to generate insight into emerging technologies in the industry and in a bite size showcase, demonstrating the benefits they can bring to your data processes.
Delegates will enjoy 3 x consecutive 20-minute sessions in which the start-ups will educate you about their platform, followed by Q&A. This is one not to miss to ensure you stay at the forefront of innovation!
12:00 pm - 1:00 pm Networking Lunch
1:00 pm - 1:40 pm THE CHALLENGES SURROUNDING DATA SECURITY FOLLOWING THE ARRIVAL OF GDPR
- Understand the key ethical and governance issues in proposed new technologies and approaches to data handling to help develop trusted and transparent environments for data reuse, grounded in FAIR principles
- Identify and mitigate risks to rights and freedoms of participants and researchers with a proportionate approach to meeting risks and challenges
- Strike the right balance between the need for data to flow to help improve care and outcomes with demonstrating trustworthiness in data use
1:40 pm - 2:20 pm COMBINING DATA TO ESTIMATE THE NUMBER OF UNIQUE PATIENTS TAKING A PRODUCT
- Identify how many unique patients are taking (or have taken) a product, which is important for safety but not previously available within sales data
- Learn how to use claims data to get a good estimate of the number of unique patients exposed to a drug
- Discuss validation of code that will be used for regulatory purposes, and how to get good results from 3rd parties hired to do technical work
2:20 pm - 3:00 pm CASE STUDY: INNOVATING REAL WORLD EVIDENCE IN NEUROSCIENCE
- Initiate large cohort studies to capture standardized qualitative information
- Understand how you can use this as your own real world data source to generate data
- Process and analyse data previously unattainable (such as speed information or physical function)
Carl de Moor
Senior Director, Head, Global Real World Evidence Strategy and AnalyticsBiogen
