Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson
11:25 AM PANEL DISCUSSION: Navigating the Complex Regulatory Landscape from Both Drug and Device Approaches
- Understanding how combination products are defined and classified globally: EU, US and Asia
- Making sense of the regulatory contradictions and focusing on the specific requirements within the EU?
- Gaining a deeper understanding of the roles of Competent Authorities and Notified Bodies
- Post Brexit impacts on drug device combination product regulations
- The importance of understanding customers requirements, the types of products they use and the associated quality issues
- Developing robust product and process design approaches along with an individual management strategy for each product type
- Best practice life-cycle management methodologies that can be used to improve patient centricity through high quality products
10:30 AM Workshop B: Alignment and Collaboration: Developing Effective Procedures and Change Management Strategy to Align Organisations and Departments
It is critical for pharmaceutical development and medical device companies to collaborate effectively on the development of Combination Products. However, because they are completely separate industries with different knowledge, experience, mind-sets and terminology there can often be a lack of understanding of the others development and manufacturing processes which can cause errors and delays.
This workshop will focus on the change management strategy that you should adopt from a top-down and bottom-up approach to ensure the company is bought into the need for change and has the right people, processes and strategy to achieve change.
Attend this workshop to:
•Understanding the current challenges: Different mind-sets, experience, terminology, drivers, skills, knowledge
•What do pharmaceutical functions need to know about device strategy and what do the device functions need to know about pharmaceutical strategy
•Establishing and developing internal processes and procedures:
oFocus: Improving communication and collaboration between external companies
oFocus: Improving communication and collaboration between internal departments
•Synchronizing device and drug schedules
•Change management strategy: Educating the entire organization and building a culture of compliance for combination products