All day: eClinical & Clinical Data Management Innovation Conference
All day June 2, 2021
This virtual event has been exclusively designed for the cutting-edge data & analytics leader, focused on aligning data strategy with digital transformation, leveraging data analytics to increase business value and use data to promote growth.
12:00 pm: Candid Conversation: How to Transform from Research to Tech Commercialization
12:00 pm – 1:00 pm June 4, 2021
Glean insights from Isamu Hartman, PhD, MBA, who harnessed education and experience to become Assistant Director in Technology Development and Commercialization at UT Southwestern Medical Center. Hear about the challenges he encountered along the way and the vital importance of networking. Attendees will walk away with actionable understanding to strengthen communication and networking skills.
All day: NAMSA Training Series: ISO 10993-18:2020 Chemical Characterization of Materials
All day June 8, 2021 – June 9, 2021
The chemical and physical characterization of materials and devices has long been considered an important step in evaluating biological safety. The most recent revisions of ISO 10993-1:2018 and ISO 10993-18:2020 continue to emphasize the importance of this evaluation and potential testing needs.
9:00 am: Lyophilized Drug Product Case Study: Risk Mitigation of Primary Packaging through Physical and Chemical Testing
9:00 am – 10:00 am June 8, 2021
This webinar will showcase a comprehensive approach to understand potential risks to lyophilized drug product quality based on chemical and physical performance testing. The discussion will cover key considerations in the study design for manufacturability and packaging leveraging this analytical approach.
All day: NAMSA Training Series: ISO 10993-18:2020 Chemical Characterization of Materials
All day June 8, 2021 – June 9, 2021
The chemical and physical characterization of materials and devices has long been considered an important step in evaluating biological safety. The most recent revisions of ISO 10993-1:2018 and ISO 10993-18:2020 continue to emphasize the importance of this evaluation and potential testing needs.
Building an effective clinical supply chain that factors in the increasing challenge of getting the necessary drug to the patient in a timely manner has never been so important. Discover how Almac partners with pharmaceutical and biotech sponsors to build optimized and efficient supply chains in their upcoming webinar.
12:00 pm: Passing an Audit: Pro Tips from a QA Expert Panel
12:00 pm – 1:00 pm June 15, 2021
For quality teams in life science organizations, implementing the best ways to prepare for and pass internal and external audits can be challenging. Getting everything prepared for an audit is a necessary, yet daunting task. While there is no one way to approach an audit, our experts will help answer common questions about audits to help you feel more confident.
12:00 pm: Microfluidic bubble sensors, Non-invasive liquid level sensors, and Autoclavable force sensors
12:00 pm – 1:00 pm June 16, 2021
New and innovative approaches to drug discovery tools, in-home dialysis care, diagnostic lab automation, and haptic feedback surgical tools have generated significant demand for equally innovative sensors to provide control data for the safe and accurate performance of these medical devices.
8:00 pm: The Critical Role of Biostatistics in Streamlining the Preclinical to Clinical Pathway
8:00 pm – 9:00 pm June 16, 2021
Obtaining market approval for a new product can create several clinical challenges for medical device Sponsors. One way in which to tackle these challenges head-on is to develop effective biostatistics processes and plans early in the development process to navigate these complexities.
In this webinar, we will discuss why you have to perform QMS Internal Audits, what the requirements are and top mistakes made by internal auditors. We will also look at the advantages of insourcing and outsourcing the audit.
All day: Biological Safety Training – June Course B
All day June 22, 2021
This two-day training course is designed for those who have received certification in the NAMSA Training Series Biocompatibility of Medical Devices – Two-Day Certification Course. Objectives of this course include practice beyond the basics of Table A.1 in ISO 10993, with increased practical application and updated workshops. In addition to traditional medical devices, we will address combination products and resorbable materials
All day: Risk Management True Quality Summit Series
All day June 22, 2021 – June 23, 2021
Medical device risk management is not optional – it is a regulatory requirement worldwide. But with today’s medical device regulatory environment changing faster than ever, and the confusion that can come with Risk Management, it doesn’t mean it’s easy. The Risk Management True Quality Summit Series will help quality, regulatory and product development professionals and executives understand and implement risk management concepts that can help meet FDA, ISO 14971, ISO 13485:2016, and the MDR 2017/745 requirements for risk management.
All day: Risk Management True Quality Summit Series
All day June 22, 2021 – June 23, 2021
Medical device risk management is not optional – it is a regulatory requirement worldwide. But with today’s medical device regulatory environment changing faster than ever, and the confusion that can come with Risk Management, it doesn’t mean it’s easy. The Risk Management True Quality Summit Series will help quality, regulatory and product development professionals and executives understand and implement risk management concepts that can help meet FDA, ISO 14971, ISO 13485:2016, and the MDR 2017/745 requirements for risk management.
12:00 pm: Streamlining Early Drug Product Development for Small Molecules
12:00 pm – 1:00 pm June 29, 2021
Are you looking to maximize the efficiency of your product development process? Join THBD for our June E-Learning Series webinar as Brent Moody, Principal Scientist of Catalent Pharma Solutions, provides insight into how to classify new therapeutic drug candidates for issues related to oral product development. Based on his 24 years’ experience in the biopharma industry, Brent offers guidance for startups and emphasizes the need to anticipate and address challenges to plan for successful preclinical and early-stage clinical studies.
This webinar will cover the principles of drug delivery, how to assess the developability of a new therapeutic small molecule for oral dosing, selecting the best clinical dosing strategy for your molecule, and the impact of early formulation decisions on timelines and costs.
Join us for an informative session you can’t afford to miss!