Friday, September 14, 2018
Join us the day after the Xavier Combination Products Summit for this Intermediate-Level Post-Summit Workshop. The workshop will be held Friday, September 14 from 8:00am - 4:00pm EST at the Xavier University Cintas Center. Facilitators Khaudeja Bano (Head Of Medical Affairs, Abbott Molecular Inc.), Susan Neadle (Head, Combination Products CoE and Sr. Director, Design-to-Value and Product Quality Management, Johnson & Johnson), and Suzette Roan (Senior Director, Global Regulatory Affairs, Sanofi) are industry thought leaders who have worked closely with FDA officials and industry associations to collaboratively shape the direction of the combination products industry.
This workshop team will explore real-world challenges you are facing, provide answers and successful practices, and real steps you can take to reduce risk to your company, products and patients.
- Foundational training on actions needed to reduce risk to your combination product. (e.g., submissions, post-approval changes)
- Deep-dive workshop on complex combination product issues you face and targeted solutions for your product’s success (including how to plan and design your Post-Market Safety Reporting environment)
- Collaborative discussions and real-world solutions for real-world problems.
Arrive at 7:30am and enjoy a complimentary warm breakfast before the class starts.
- Case studies, including foundational and advanced scenarios that are linked to real-world experiences.
- Stepwise strategies for you to bridge your practices to regulatory expectations.
- Understanding FDA inspection findings related to key quality systems that have combination products complexities.
- Engage in exercises with your colleagues relevant to your products and your company.
- Exploration of critical guidance documents.
- How to adapt your practices with clear standard operating procedures to support quality assurance.
Analyze with Khaudeja, Susan, and Suzette:
- Real-world lessons learned in combination products lifecycle
- Successful practices for planning and developing your combination product quality systems
- Establishing a dependable Post-Market Safety Reporting practice
- Pitfalls to avoid through your product submission and approval process
- Navigating post-approval changes
- Key aspects of FDA guidance documents that can shape your practices today
The Post-Summit Workshop, Friday, September 14, 2018, from 8:00am-4:00pm EST, is $850 and only $685 when you also register for Xavier Combination Product Summit. For complete information on planning your trip to the Workshop, click here. Note: A shuttle between Xavier and the Hilton will not be available for this class.