Conference Day One

8:30 am - 8:55 am Registration and Coffee

8:55 am - 9:00 am PharmaIQ Welcome

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Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

9:10 am - 9:40 am Speed Networking

A highlight of Pharma IQ events! Be ready to meet your peers and share best practices. You will have several 2 minute conversations to enable you to introduce yourself to your peers. There is a prize in it for the winner, so, get networking!
Please Share:
1. Who you are
2. The scope of your job role
3. What you plan to achieve from attending this event
4. Your #1 challenge


• Combination Products Regulations are evolving globally, one consistent undercurrent to this dynamic regulatory environment is the drive for success
• Discuss practices and control strategies throughout the combination product lifecycle, to assure public health, ensuring risk is commensurate with product complexity and patient needs
• Review combination products risk management considerations and essential performance requirements to support robust product development and lifecycle management
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Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

10:20 am - 10:50 am Networking Coffee Break

10:50 am - 11:30 am Management of Device and Device Component Suppliers in a Combination Product Environment

Gino Depeser - Senior Manager External Quality, Janssen
• Discuss the impact of combination products regulations on device and device component suppliers in a pharmaceutical environment
• Explore the creation of remediation plan for existing device and device component suppliers
• Review the management of new and existing device and device component suppliers
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Gino Depeser

Senior Manager External Quality
Janssen

11:30 am - 12:10 pm Combination Product Development: Learning From Real World Use Problems

Daniela Gramaglia - Device Development Specialist, Chiesi Group
• Discuss the integration of device development into the drug development process
• Understand use problems correlated with safety and efficacy
• Develop strategies to employ during device design to reduce use-related hazards

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Daniela Gramaglia

Device Development Specialist
Chiesi Group

12:10 pm - 1:10 pm Networking Lunch

1:10 pm - 1:50 pm Case Study: Engineering Combination Products Towards a New Path with Insulin Biosimilars

William Denny - Device Project Leader, Device Development & Commercialisation, Novartis
• Look at the commercialisation of biosimilar versions on insulins, used to treat patients with type 1 and type 2 diabetes 
• Discuss the challenges associated with developing the combination products
• Specifically review how to make the combination products affordable for patients


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William Denny

Device Project Leader, Device Development & Commercialisation
Novartis

1:50 pm - 2:30 pm How Safe Are My Devices? Regulatory Compliance Lifecycle Management of Combination Products

James Wabby - Executive Director, Regulatory Affairs (Devices and Combination Products), Allergan
• Understand the importance of user needs and usability
• Look at quality system requirements for regulatory compliance
• Discuss design control and product development management to ensure product safety
• Review case studies on clinical trials and complaint management

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James Wabby

Executive Director, Regulatory Affairs (Devices and Combination Products)
Allergan

2:30 pm - 3:10 pm A Holistic Approach to Pharma Solution Development

Cedric Gysel - Manager, Healthcare Solutions Design, Johnson & Johnson Design
• Identify how you can address the needs of a changing world at the design stage
• Look at design as an enabler for change
• Discuss transforming pharmaceutical development with real case study examples

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Cedric Gysel

Manager, Healthcare Solutions Design
Johnson & Johnson Design

3:10 pm - 3:40 pm Networking Coffee Break

Use this opportunity to benchmark with your peers and identify the key strategies required to overcome specific challenges. This will run as 2 x 25 minute rotations and a short recap fed back to the group.

1. Industry Elements in Relation to Article 117
                
2. Application of Design Controls in the Development of Combination Products            

3. Risk Management of Combination Products

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Amanda Matthews

Sr. Director, Regulatory CMC for Combination Products & Medical Devices
Pfizer

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Sanjay Jain

Associate Engineering Director, Device
Janssen

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Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

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Susan Neadle

Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design
Johnson & Johnson

4:50 pm - 4:50 pm Drinks Reception