Tuesday June 25, 2019
Workshop A: How Regulatory Affairs Can Drive a Robust Combination Product with Business Continuity and Smooth Approval?
08.30 – 11.30
The fast evolving regulatory environments in combination products can be challenging for drug-device developers. Gaining a thorough understanding is step one but being able to leverage this will help ensure smooth approval, speed-to-market and maximize your product’s commercial competitiveness.
This workshop will be separated into two mini sessions with built-in group discussions and exercises, giving you a hands-on experience and key takeaways on the following areas:
|Session 1: How to Manage Post-Approval Change Details?
Change is inevitable during combination product’s lifecycle. Being able to anticipate change and mitigate risks can ensure business continuity and maintain a quality product for patients.
This session will look at the various types of specific changes using an example of PFS to auto injector for discussion.
|Session 2: TPLC/ Line Extension Consideration for Your Next Gen Combination Products
Winifred Wu, President, Strategic Regulatory Partners, LLC
Workshop B: Turning Risks into Opportunities in Your Combination Product Development
12.00 – 15.00
Quality and risk management are no longer separate functions in a drug-device program. They should be heavily involved and integrated to the LCM from the beginning of the product design journey. This session will help attendees understand:
- What a good QMRS framework look like
- Why you should involve risk management team early on
- Think outside the box – turning risks into an opportunity. How can you improve your product based on risk profile?
- Post-launch management in both changes and risks
- Why and how a good QMRS can increase your product’s patient adherence
This will be a hands-on and interactive session with built-in exercises which we encourage participants to get involved with for the best learning results.
Naveen Agarwal, Principal & Founder, Creative Analytics Solutions
Workshop C: It All Starts from R&D – Product Design to Extend Lifecycle
15.30 – 18.30
A successful combination product begins at the product design stage. Designing a patient-centric product with unique features will no doubt maximize your commercial opportunities and product life span.
This is obviously easier said than done, and this workshop will be a deep dive session focusing on:
- How to embed a UX-culture and LCM-mindset at the start of your product design
- What are the parameters and considerations? Planning your next generation product early on
- Combination product progression – an incremental change can make a huge difference
- Who should you collaborate with? Market access and launch planning
- Case studies of successful product evolutions to capture patients’ hearts
Alastair Clarke, Managing Principal, Weaver Technical Solutions
Prasad Peri, Senior Director, Regulatory Affairs, CMC, Teva