January 13 - 14, 2021
April 13-15, 2021 - 10:00 a.m. - 2:00 p.m. Daily
This 3-day virtual workshop (4 hours per day) brings together industry experts and thought leaders in a unique forum to address a series of challenges and to learn practical strategies to mitigate risk in Combination Product development and commercialization.
Key Challenges & Risks to be addressed are:
- Translation of regulation to development execution
- Drug & Device Integration
- Device reliability & robustness
- Change & Lifecycle management
December 3, 2020 -View OnDemand
In November 2019, the International Council for Harmonization (ICH) Q12 guideline entitled Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management was finalized. This webinar will provide an overview of the guideline and will explain the Established Conditions (EC) discussed therein, as well as the applicable regulatory requirements. A deep dive into Post Approval Change Management Protocols (PACMP) and Product Lifecycle Management (PLCM) as tools to manage change will also be discussed.
November 12, 2020 - View OnDemand
Generic organizations will be required to continue to provide high quality in their drug manufacturing processes and bring their products to the market faster. They must also have a mindset that fosters operational simplicity and excellence to enable these requirements. With these needs in mind, this webinar will offer insight into the West’s AccelTRA® Elastomer Components Program
November 5, 2020 - View OnDemand
This webinar will explore why adherence, safety and quality of life are important for patients, and how these key enablers contribute towards positive outcomes. We will also discuss existing challenges, such as drug development, regulatory, patient accessibility, and how device technologies can further improve patient outcomes.
October 28, 2020 - View OnDemand
With the growth and success of biosimilars in the market, successfully bringing one to market is top of mind for many pharmaceutical manufacturers. This webinar will cover the trends and regulations around biosimilars and approaches for qualification of packaging and delivery systems for bringing a biosimilar to market.
October 21, 2020 -View OnDemand
It’s been estimated that of the 35 million global healthcare workers that exist, 2 million of them suffer needlestick injuries each year, with approximately 500,000 of these occurring in the US. Of these, about 40% of cases go unreported each year. Due to these high numbers, regulations, laws and directives have been set to try to reduce needlestick injuries among healthcare workers. Consequently, some customers are now scrambling to understand what safety devices exist for their current and pipeline prefilled syringe (PFS) products. This webinar will discuss the need for safety devices and how the current COVID-19 pandemic is expected to accelerate adoption of regulations set to increase the use of safety devices to safeguard healthcare workers.
September 30, 2020 - View OnDemand
This webinar will place the oncology patient and the drug company at the heart of the conversation and will give situational awareness of the challenges both parties face, along with the proven solutions to help overcome these challenges.
September 17, 2020 - View OnDemand
This Webinar will explain the baseline requirements for elastomeric physiochemical and functional properties. Examples to illustrate qualification of components for intended applications will be included. A strategy for testing the entire packaging and delivery system inclusive of the drug product is essential. These USP updates are meant to increase patient safety by reducing risk through more thorough product understanding beyond component level testing, and these significant changes will be highlighted.
July 16, 2020 - View OnDemand
This Webinar, presented by Christa Jansen-Otten and Whitney Winters on July 16, 2020, explains the key critical product requirements, such as performance studies in prefilled syringes, container closure integrity, dimensional measurement results and particulate measurements that can be used to support delivery system assessment and implementation at pharmaceutical companies.