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Sept 5 – 7, 2018
San Diego

Day One
Thursday September 6, 2018

Day Two
Friday September 7, 2018

Morning Coffee & Registration

Chair’s Opening Remarks

Ensuring a Regulatory Compliant Injectable Device

Opening Address: How Safe is Your Safety Device?

  • Joseph Purpura Executive Director, Medical Device Safety Physician, Medical Devices, Allergan


  • From Quality System Regulation (QSR) 21CFR820 to design control requirements – reassure your device’s safety and effectiveness for the intended users, uses and use environments
  • Can you identify possible use errors and mitigate the associated risks?
  • Re-validate legacy product and collate feedback from users’ post-launch to enhance safety features

Combination Products Regulatory Expectations from the Agencies


  • Combination products approval guidelines – what data is required for filing?
  • Updates on CRF21 Part 4 – cGMP and multi-site manufacturing oversight

Speed Networking & Morning Refreshments

The Human Touch – Developing a User-Friendly Device for Your Patients

How to Anticipate the 2020 Deadline – EU Medical Device Directive

  • Gay Steinbrick Lead Medical Device & Combination Products, Global Safety, Merck


  • Key changes with MEDDEV Rev 4
  • Looking ahead to EU MDR
  • Clinical evaluation reports for drug delivery device constituents

The New Beginning after Launch – A Device Regulatory Perspective and Journey


  • Post-launch regulatory considerations and executing a robust change system for device
  • Regulatory affairs’ role during the evolution of injectable devices – from PFS to on-body injector
  • Case study: Amgen’s success story and lesson learned

Tech-Show at Exhibition Hall


  • Live demos from our technology partners to showcase how latest PFS and injectable innovations.
  • Delegates will get the chance to ask questions during this interactive sessions.

Lunch & Networking

Human Factors Study – How, When, What and Who?

  • Young Chun Principal Engineer – Human Factors Lead, Shire


  • It’s not a check box exercise: devising a thorough design plan for your HF study
  • When should you conduct and what’s the optimal sample size?
  • Defining your sample pool for a meaningful study

Human Factors within the Device Design Control Paradigm

  • Nick Zampa Senior Engineer, Technical Development Human Factors & Risk Management, Biogen


  • How can a human factors approach enable more robust risk management?
  • Knowing your intended users to make risk-based decisions about device design.
  • Integrating human factors as part of the broader device development process within Pharma/Bio-Pharma
  • Post-launch: role of human factors during post-market surveillance?

A Different Perspective – Biosimilars Combination Product Development Considerations and Challenges?

  • Alasdair Young Associate Director - Device Engineering , Coherus BioSciences


  • Biosimilars and interchangeability:
    • A perspective on current human factors guideline
    • The impact on technology selection
  • Developing a biosimilar as a combination product
    • Anticipating and addressing potential challenges with characterizing a reference product
    • Differentiation – managing technology platform across products

Reflections & Actions


Based on the previous talks, audience can choose their preferred tracks for a focused discussion and experience sharing. Please nominate a leader to steer the conversation and feedback one top tip for the rest of the audience at the end of the 30mins discussion.

Track 1: How best to handle regulatory changes for injectables/ combination products in a global environment?

Track 2: Human factors engineering approaches

Track 3: Challenges with outsourced and off-the-shelf platforms/ device components

Afternoon Refreshments & Networking

Case Study: Journey of Drug-Device Integration


  • QbD thinking and design controls
  • Risk-based approach to human factors study and validation
  • Parameters and considerations for generic PFS and injectables
  • Looking ahead: where do opportunities and challenges lie?

Less is More – Delivering a High Volume, Highly Viscosity Drug with Precise Dosage

  • Amy Wang Director Drug Delivery & Device Development, Alexion Pharma


  • With trends turning towards less frequent administration and larger dosing, what does it mean to existing formulation and drug delivery options?
  • Addressing the challenges of highly concentrated and highly viscous drugs during injection
  • Different platform selection criteria and considerations
  • Challenges to work with confined parameters and lessons learned

Downsizing: Microneedle Opportunity in Injectables


  • How micro can a microneedle injectable be?
  • Formulation and efficacy challenges
  • Applications and opportunities – patient adherence and ease of self administration

Chair’s Closing Remarks

Close of Day 1