Combination Products: Regulatory Approach and cGMP Requirements (On-demand)

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Combination Products: Regulatory Approach and cGMP Requirements (On-demand)

This is an On-demand recording from December 2021


Description

Combination products represent a noteworthy prospect for the user with regular and long-term dosing requirements. The availability of commercialized devices with automated functions is increasing and this may benefit and reduce the burden on the user and on healthcare systems.

This webcast will walk you through the regulatory approach and the new regulations applied for combination products. It will also cover the elements of the current Good Manufacturing Practices (cGMP) requirements that are applicable for drug-device single entities and co-packaged combo products.

This webcast will cover:

  • cGMP requirements for the classification of drug-device combination products
  • The common pitfalls drug companies face when they pursue the development of a combination product
  • The best approach for the development of drug and device products
  • Risk management and control strategies
  • The new regulations applied for combination products
  • Labelling requirements


Speaker(s)

Mina Gavrilova

Quality Manager, Huvepharma EOOD

Mina Gavrilova is quality manager within the global quality group at Huvepharma EOOD, a pharmaceutical company headquartered in Sofia, Bulgaria with multiple sites worldwide. Gavrilova has more than 15 years of combined working experience in quality control, quality assurance and quality management in the pharmaceutical and environmental science industries. Her expertise includes analytical chemistry, GMP and GLP, and computerized systems implementation. In addition, for the past few years Gavrilova has played a major role as project manager of several successfully completed computerized systems implementations.


Stephen Fischer

Product Analyst, ETQ

Stephen Fischer serves as product analyst at ETQ. In this role, has implemented the company’s quality systems management software for more than nine years across multiple markets and technologies. His work has taken him deep into the business processes, system functionalities, and planning—including strategy and tactics—necessary for successful implementations of the ETQ Reliance software. Fischer works to create the best product experience possible for current and future ETQ customers..