22 - 24 October, 2019 | Berlin, Germany

Pre-Conference Focus Day

8:00 am - 8:15 am Registration and Coffee

8:15 am - 10:15 am Workshop A: Combination Products cGMPs: Application of FDA Medical Device Regulations Required by the Drug cGMP Streamlined Approach of 21 CFR Part 4

Pharmaceutical companies that have traditionally designed and manufactured combination products for the U.S. need to update their quality management system to the device requirements of 21 CFR Part 4. Although most of the industry is aware and doing their best to comply, guidance is still needed on how to implement and maintain compliance. This workshop will focus on a deep dive review on the elements of 21 CFR 820 quality system regulations for medical devices that are outlined in the drug cGMP streamlined approach of 21 CFR Part 4 Combination Products Final Rule: Management Responsibilities, Design Controls, Purchasing Controls, Corrective and Preventive Action, Installation, and Servicing.

Attend this workshop to:
  • Gain an applied knowledge on the medical device requirements for combination products
  • Gain the skill of assessing a combination product developer or manufacturer
  • Gain applied knowledge of the regulations via real world case studies of FDA 483s and warning letters of medical device and combination product developers/manufacturers
  • Brainstorm to create tools and forms that can be used on current projects related to combination product development such as: 
  1. Management Review Forms
  2. Quality Planning Approach
  3. Design History File Traceability Matrix
  4. Design History File Remediation

10:15 am - 10:30 am Morning Coffee Break

10:30 am - 12:30 pm Workshop B: Alignment and Collaboration: Developing Effective Procedures and Change Management Strategy to Align Organisations and Departments

Susan Neadle - Head, Combination Products CoP and Sr. Director, Global Value Chain Quality Design, Johnson & Johnson
It is critical for pharmaceutical development and medical device companies to collaborate effectively on the development of Combination Products. However, because they are completely separate industries with different knowledge, experience, mind-sets and terminology there can often be a lack of understanding of the others development and manufacturing processes which can cause errors and delays.  

This workshop will focus on the change management strategy that you should adopt from a top-down and bottom-up approach to ensure the company is bought into the need for change and has the right people, processes and strategy to achieve change.

Attend this workshop to:
•Understanding the current challenges:  Different mind-sets, experience, terminology, drivers, skills, knowledge
•What do pharmaceutical functions need to know about device strategy and what do the device functions need to know about pharmaceutical strategy
•Establishing and developing internal processes and procedures:
oFocus: Improving communication and collaboration between external companies
oFocus: Improving communication and collaboration between internal departments
•Synchronizing device and drug schedules 
•Change management strategy: Educating the entire organization and building a culture of compliance for combination products

Susan Neadle

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

12:30 pm - 1:15 pm Lunch Break

1:15 pm - 3:15 pm Workshop C: Navigating the Complex Regulatory Landscape to Ensure Compliance and Approval of Combination Products

Tina Amini - Head of Notified Body, Lloyd's Register
The regulatory landscape within the EU has remained complex, confusing and inconsistent. It is continuing to evolve which adds to the challenge, but without ensuring compliance you are unable to launch a combination product.

This workshop will focus on the different regulations that apply to combination products and specific guidelines that will help ensure you remain compliant. 

Attend this workshop to:
•Gain knowledge on the different regulations that apply currently to different combination products: Similarities and differences in drug and device regulations
•Learn how to develop and consolidate the standards into one streamlined process to meet the requirements throughout the lifecycle of the combination product
•Minimise and manage risks associated with regulatory challenges and identify key success factors
•Reduce the time spent on approvals and likelihood of agency push back
•Discuss how human factor considerations are assessed and controlled in the drug/device user interface

Tina Amini

Head of Notified Body
Lloyd's Register

3:15 pm - 3:30 pm Afternoon Tea and Networking Break

3:30 pm - 5:30 pm Workshop D: Human Factors Considerations for Combination Products: Usability and Engineering

The design of a combination product will have a huge impact on whether the product is safe, effective and compliant. Because of this, human factors and usability engineering play a significant role in ensuring product quality and that it meets the requirements for their intended use. 

This workshop will guide through the regulation, design strategy, assessment considerations and safety testing to ensure your products are safe, reliable and user centric. 

Attend this workshop to:

•Get to grips with the regulatory landscape: What information should be provided, when and how?
•Better integrate design controls and human factors: Creating and implementing a quality system and design control strategy for compliance
•Determine user requirements and translating the outcomes into design outputs
•Gain clarity around formative evaluations and hazard mitigation
•Discuss Human Factors and Safety Testing: Recommendations on approaches for design and validation testing as well as how this differentiates between products