Pre-Conference Workshops

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.

  • Prospective LCM changes from PFS to AI: design control and clinical bridging requirements
  • Reactive LCM changes: supplier change for device constituent supplier: material/ component change, and device design change for enhanced safety features
Session 2: TPLC/ Line Extension Consideration for Your Next Gen Combination Products

  • This session will explore the regulatory pathway and general data requirement to support a new presentation of existing combination product, and how RA can provide support during design control process.
  • We will use a hypothetical line extension case for participants to discuss the data requirements of providing an additional presentation of a combination product for different intended users and use environments.

Led by:

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.

Led by:

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

Led by:

Alastair Clarke, Managing Principal, Weaver Technical Solutions

Prasad Peri, Senior Director, Regulatory Affairs, CMC, Teva