Report

October 16

Post Market Requirements - A journey, not a destination

Broughton Nicotine Services, Director of Product Safety and Compliance, Yvonne Wilding has recently published an article with leading sector publication Tobacco Reporter.

Yvonne discusses navigating successful post-market requirements for ENDS products and why it is a journey, not a destination.

A journey, not a destination

Last month marked the deadline for submitting premarket tobacco product applications (PMTA), many companies are waiting for notification of acceptance for filing, substantive review or awaiting the arrival of deficiency letters. Upon receipt of a marketing order, regulatory obligations continue for the entire life cycle of a product in the market. The Food and Drug Administration (FDA) extensively evaluates the data at intervals to make a re-assessment of risk-benefit and ascertain the product’s suitability to be keep the designation “appropriate for the protection of public health” (APPH).

Post Market Surveillance (PMS)

PMS responsibilities are complex. They encompass multidisciplinary functions within a business, and involve in-depth data gathering and analysis, submitted on a frequency agreed with the regulatory authority. This article delves into the requirements which can be put into three main categories:

  • Changes to manufacturing processes and controls
  • Changes to the health risks associated with the product
  • Sales, distribution, and marketing information
  • Compliance with all these aspects is necessary to ensure the product is maintained in market

You can read the full article here:

A Journey, Not A Destination

Can we help you?

Broughton Nicotine Services have deep CRO capabilities and an experienced team of scientific and regulatory professionals to manage full service global regulatory projects. Our knowledge of global regulatory pathways offers significant insights that can be incorporated into your project plans. Our mission is to accelerate safer nicotine-delivery products to market; advancing a smoke-free future.

Book a meeting with us today to discuss your requirements.

 

About the Author

Yvonne Wilding is the Director of Product Safety and Compliance. She has over 10 years of broad regulatory toxicology experience and 20 years of pharmaceutical drug development Research & Development leadership. She has been responsible for numerous MAA and NDA submissions, for both small molecules and biologics and has experience stretching from early candidate selection through life cycle management of new medicines. Her toxicology experience was gained with GlaxoSmithKline's (GSK) large portfolio of respiratory products in a specialized inhalation toxicology department. Yvonne began her career as a regulatory toxicologist for GSK responsible for designing the strategic drug safety evaluation programs to satisfy all global markets using both in-vivo and in-vitro approaches; for operational delivery both with an in-house team and with Contract Research Organisations (CRO). This involved working closely with clinical teams and key opinion leaders to ensure patient safety at each stage of development. She has extensive experience of interacting with regulatory agencies. Following on from Toxicology, Yvonne was responsible for managing and leading drug development programs encompassing all functional disciplines to ensure delivery of successful marketing applications and to maximise the commercial opportunity for each product. Yvonne’s clinical experience encompasses clinical program strategy, study management, clinical portfolio management and pharmacovigilance. Most recently, Yvonne worked with AstraZeneca in the Precision Medicine department to develop new diagnostic tests and submit PMA applications for companion diagnostics devices evaluating genetic biomarkers of disease susceptibility in collaboration with major diagnostic companies.