Thursday September 6, 2018
08:00 Morning Coffee & Registration
09:00 Chair’s Opening Remarks
Ensuring a Regulatory Compliant Injectable Device
09:10 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
09:40 Combination Products Regulatory Expectations from the Agencies
- Jennifer Hefele Wald Director Global Regulatory Affairs Combination Products, Pfizer
- Combination products approval guidelines – what data is required for filing?
- Updates on CRF21 Part 4 – cGMP and multi-site manufacturing oversight
10:10 Speed Networking & Morning Refreshments
The Human Touch – Developing a User-Friendly Device for Your Patients
11:45 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
12:15 The New Beginning after Launch – A Device Regulatory Perspective and Journey
- Kesley Gallagher Senior Regulatory Affairs Manger, Amgen
- 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
12:45 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.
13:00 Lunch & Networking
14:00 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
14:30 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?
15:00 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
15:30 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
16:15 Afternoon Refreshments & Networking
16:45 Case Study: Journey of Drug-Device Integration
- Karthik Balasubramanian Associate Director, Global Device R&D Operations, Teva Pharmaceuticals
- 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?
17:15 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
17:45 Downsizing: Microneedle Opportunity in Injectables
- Faz Chowdhury CEO, Nemaura
- How micro can a microneedle injectable be?
- Formulation and efficacy challenges
- Applications and opportunities – patient adherence and ease of self administration