52nd AAPS Arden Conference: Development and Regulation of Combination Products through Design Controls

The conference will begin by highlighting the current regulatory requirements for the development of combination products, including how combination product development is different from the development of traditional pharmaceuticals.

Goals and Objectives

Next, the focus of the meeting will on the development of injectable, transdermal, inhalational, and pulmonary drug products that utilize or incorporate drug delivery devices. This discussion will focus on how medical device Design Controls are required by regulation and how these are being applied in the development of drug delivery systems. The conference will begin by highlighting opportunities and challenges surrounding efforts to develop drug and biologic delivery systems that are combination products and understand the current regulatory framework for their development and registration. This includes a discussion on the developmental challenges that are different from traditional pharmaceuticals, in particular the requirement to utilize Design Controls during the development of device containing combination products.

Expected Outcomes

  • Attendees will understand the quality system requirements for the development of drug (and biologic) delivery systems, in particular Design Controls.
  • Participants will understand the regulatory process in the approval of the combination products that are developed as injectables, pulmonary/inhalation, nasal sprays, transdermals.
  • Attendees will know case studies in each of the combination products that are discussed at the workshop.  

Who Should Attend

Open to all scientists in preclinical and clinical development, interested in branded and generic Combination products. Particularly relevant for biologics, and for alternative routes of administration, also industry scientists initiating or experienced in combination products.