Understanding and Addressing Technical, Quality, and Regulatory Challenges for Drug Delivery Combination Products - New Course

Huntington Beach, CA
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Duration:  1 day
Time: 8:30 a.m. - 4:00 p.m.

This course will have interactive discussions of the challenges companies will face in the development and registration of drug delivery combination products. The course will cover:

1. Applicable regulatory schemes in the US and EU and some potential regulatory strategies
  • Brief history and basics of regulatory definitions
  • Application of regulations and directives to drug delivery
  • Differences between US and EU requirements
  • Regulatory strategies
2. Impact and expectations for GMP/QSR compliance
  • US GMPs
  • Key quality systems expectations during design
  • EU Requirements
  • Leveraging partner’s systems
3. Technical requirements - creation of a design history file
  • Unique in-vitro and animal testing requirements (performance/functional requirements, material requirements, and stability expectations)
  • Risk management and human factors requirements and expectations (risk management requirements and usability requirements)
4. Current clinical requirements, expectations and challenges
  • Current clinical expectations and strategies for clinical bridging
5. Partner (vendor) selection and oversight
  • Product criteria
  • Partner criteria
  • RFP process
6. Format, elements and data requirements for marketing authorization submissions

Who Should Attend

This course will be geared towards individuals that have input to, oversight for, or actively participate on drug delivery combination product development teams. This includes the following practitioners, managers and directors in medical device, pharmaceutical or consulting companies:

  • Project management
  • Marketing
  • Regulatory Affairs
  • Quality Assurance
  • Clinical Affairs
  • Human Factors Engineering
  • Device Development Engineering
  • Quality Engineering
  • Formulation
  • Testing laboratories
  • Design Verification Department
Event Location
Hyatt Regency Huntington Beach Resort and Spa
21500 Pacific Coast Hwy, Huntington Beach, CA Get Directions

Contact

Program Inquiries
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More information coming soon.

Day 1

Upon completion of this course, you will be able to:

  • Explain the basic elements and requirements behind the regulation of drug delivery combination products
  • Plan, propose and choose appropriate regulatory strategies
  • Develop a set of criteria with which to assess and choose device partners
  • Explain the GMP/QSR expectations and responsibilities relevant to companies developing and manufacturing these products
  • Describe the expectations for a robust risk management and human factors engineering systems and, if qualified, execute a successful development program
  • Identify the appropriate testing schemes and requirements specific to your products
  • Outline the contents of a clinical or marketing approval application

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Hyatt Regency Huntington Beach Resort and Spa

21500 Pacific Coast Hwy
Huntington Beach, CA ,
Lee Leichter, RAC, MBA

Lee Leichter has over 35 years’ experience in the health care industry. He has been providing direct, hands-on assistance to domestic and international Pharmaceutical, Biotechnology and Medical Device companies for the last 15 years. Projects have encompassed a multitude of business, technical, regulatory and quality issues, mostly relating to drug delivery and combination products for marketing in the USA, Europe and Canada. He has worked with large multi-national companies and start-ups successfully navigating the challenges posed during the development, testing and marketing approval of products that merge pharmaceutical substances with high-tech device systems.

He serves as an independent expert on the ISO technical committees for Injection and respiratory products, infusion pumps, needles and catheters, and AAMI Injection and Infusion Devices and Human Factors committees, and is convener of the Bolus Injector Workgroup; helping establish international standards for safety and performance of these products. He has directly proposed and responded to FDA positions and proposals covering combination products, most recently as a consultant to the Combination Products Coalition. He is also the Chairman of the PDA Combination Product Interest Group.

He holds a Bachelor’s degree from the State University of New York at Stony Brook and an MBA with Honors from Florida Gulf Coast University. He was certified as a Quality Engineer from ASQ and is currently certified in USA and EU Regulatory Affairs from RAPS.