Taking place on 14th October at 3PM London / 10AM New York, our latest webinar will focus on exploring the challenges handling controlled substances. We will provide some real-life examples of the challenges and explore how we solve them at Recipharm.
We will discuss these points from two different perspectives:
1. A practical point of view
We will look into the regulatory requirements when importing and exporting controlled drugs, including the moving and storage of the material, as well as the key documentation requirements for the accurate recording of material disposition and reconciliation.
We will also discuss the requirements for compliant facility design, including internal security and product containment. A review of Material Safety Data Sheets and production of appropriate CoSHH assessments will also be discussed.
2. Keeping the development process simple
In addition to regulations, logistical and safety considerations, we will discuss steps to streamline and simplify the development process. We will explore simple formulations to minimise API loss.The importance of working closely with drug substance suppliers to target key API properties will also be discussed.
We will explain how the use of clever excipients, optimised containment and streamlined manufacturing steps will not only ensure regulatory compliance, but can also mitigate the risk of API powder loss. We will also explore the need for formulators to produce abuse deterrent formulations.
Key Learning Objectives
- Understanding the implication of rules and regulations when developing control drug products
- Gain a clear understanding of operational and logistical requirements for handling control drugs.
- Ability to manage the challenges and solutions during control drug product development
- Understand the importance of simplifying controlled drug product manufacturing processes
Target Audience
- Analytical services /-Manager/-Director/Head of-/VP -,
- CMC /-Manager/-Director/Head of-/VP -,
- Development /-Manager/-Director/Head of-/VP -,
- Formulation development /-Manager/-Director/Head of-/VP -,
- Pharmaceutical development /-Manager/-Director/Head of-/VP -,
- Chemistry/Medicinal Chemistry /-Manager/-Director/Head of-/VP -,
- Founder and CEO,
- Procurement /-Manager/-Director/Head of-/VP -,
- CSO,
- COO
