Understanding regulations and developing control drug products that comply easily
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.
Presented by
Arul Balasundaram,
Formulation Manager
Arul Balasundaram is Formulation Manager at Recipharm’s Queenborough facility. Arul is responsible for overseeing all formulation development and clinical manufacturing activity, as well product development and the remediation of commercial projects. Before starting his role at Recipharm, Arul held positions at large pharma companies including Pfizer and GSK. A subject matter expert in quality by design, solubility enhancement technologies & paediatric drug development, Arul has extensive experience in solid dose, controlled drugs and dry powder inhalation and nasal combined devices.
Dave Bland,
Development Director, Recipharm’s Queenborough facility
Dave Bland is Development Director at Recipharm’s Queenborough facility. Dave is responsible for overseeing all clinical activities, generic development, and remediation projects. With more than 30 years’ experience in the pharmaceutical industry, he brings a range of knowledge and expertise to the Recipharm team. Prior to his role, he has held several senior positions in production, operations, and development, both in the UK and abroad.
Aaron Small,
Vice President Global Development Sales
Aaron Small is Vice President Global Development Sales at Recipharm. He holds a BSBA degree in marketing and an MBA and has been a part of Recipharm since 2011. During his time at Recipharm he has contributed to business development activities for both development and manufacturing services. In addition, Aaron has been a part of brand development and deployment for the North American market.