Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects for a number of valid reasons. One of the main reasons is that medical device regulatory and quality professionals are often responsible for overseeing the development of combination products that include small or large drug “active pharmaceutical ingredients” to achieve the clinical therapeutic effect.
In many pharmaceutical organizations, the medical device professional is often expected to take the lead role in overseeing all aspects of regulatory and quality compliance, including Chemistry, Manufacturing and Controls (CMC) aspects, particularly when the “primary mode of action” (PMOA) relates to the device component. It is here that Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects, because Regulatory and Quality engineers are often ill-equipped to manage the CMC aspects of projects.
This is because being technically trained personnel; they have scant knowledge of even the basic functions of the chemical, molecular structural, drug manufacturing process and analytical methods associated with the “active pharmaceutical ingredient” component.
Need to be able to understand technical elements of medical devices and combination drugs
Yet, that medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects cannot be ruled out, because since subtle chemical issues are integrally related to product performance, they need to be able to understand technical elements of medical devices and combination drugs.
The professional in charge of Regulatory Affairs (RA) needs to have a clear understanding of how drug chemistry impacts drug/device performance. The RA Lead needs to have answers to questions relating to:
o The proper storage and environmental condition for simple molecules, peptides, polypeptides and proteins
o The ways in which the drug impurity levels change as the product is combined with the device components
o The way “Quality by Design” (QbD) ensures drug performance
o The methods by which an analytical method should be validated to meet FDA CDER requirements
o The indicia of drug stability
Since it is questions such as these that frequently arise during FDA product evaluation, Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects.
A major learning session to help understand these aspects
Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will organize a learning session to help understand these aspects, at which these and related aspects of managing drug and device combination product project will be imparted.
The speaker at this webinar is Robert Michalik J.D, RAC, a Massachusetts regulatory attorney and founder of RegulatoryPro.com, a consulting firm providing general and specialized services to the biopharmaceutical and medical device industries. To enrol for this webinar, please visit
Robert will familiarize participants with the basics of small molecule and larger molecule (protein chemistry) development and testing. Using this as the basis, he will offer real world practical situations that arise in this field, which will help participants to become aware of how to spot problems that are a routine occurrence in every product development program. Being able to spot a CMC problem is more important than having the knowledge to fix it, because the FDA does not expect a company to solve it, but rather that it understands how the agency locates the problem.
Robert will cover the following areas at this session:
Chemistry 101: A review of the basics
- Molecular structure and its impact on drug activity (smaller molecules behave differently from larger molecules)
- Techniques commonly used in drug synthesis, manufacturing and quality control testing.
- CMC Regulatory Compliance: Brief but comprehensive review of the essentials
- How to spot a CMC-related problem and what to do when you suspect one.
- Case studies that illustrate common issues that arise relating to drug components in combination device products
- FAQs and Essential follow-up reading for those who want more resources
Medical Device Regulatory and Quality professionals need to have essential knowledge to manage drug and device combination product projects