September 14 -16, 2021
Online Training Course
LEARN HOW TO DEVELOP AN EVOLVING ANALYTICAL CONTROL STRATEGY FOR YOUR OLIGONUCLEOTIDE DRUG SUBSTANCE
The course will also discuss the issues and risks that can be developed, addressed and mitigated during development
Benefits of Our Training Courses
Informa training courses provide in-depth teaching and discussion about highly technical and scientific topics relevant to the TIDES community that can not be covered at a conference. With 6+ hours of dedicated instruction in a classroom-like (teacher/student) environment, a training course will offer you interactive opportunities with the instructor and fellow attendees so you can get your most pressing questions answered in a much more individualized setting.
We do our best to schedule the training courses at a "global-friendly" time. However, if the timezone doesn't work we always record our training and they're available for 30 days post-event to enhance your learning.
Login Details 1 Week Prior
Attendees will receive their login instructions 1 week before the course start date so they can get familiar with the training course platform in preparation for the course.
Dedicated Q&A Times
Get all your questions answered with our dedicated Q&A times built right into the agenda. The instructor also does daily recaps of prior days lessons to make sure everyone is up to speed.
Digestible Content & Presentation Access
Conveniently scheduled over 3 days in 2.5 hour segments to make the detailed content more easily digestible. Attendees are also able to download the instructor presentation slide deck for each day and keep the slides for future reference
Training courses offer a more personalized interaction with the instructor to answer your specific questions and give feedback in a classroom like setting
Detailed Course Agenda
A detailed course agenda and outline of topics to be covered is listed on the training course website so you know exactly what you will learn
What Will You Learn?
- How to determine a Quality Target Product Profile (QTPP) from the preclinical phase through clinical development
- How to identify Critical Quality Attributes (CQA’s) and set specifications from early development through clinical development.
- How to design analytical methods to support the QPP, CQA’s and specifications.
- Overview of regulatory expectations for therapeutic oligonucleotide drug substances in terms of specifications and impurity control
- How to approach risk assessment and the identification of Quality Critical Attributes during late development
Who Should Attend?
- Analytical Chemists
- Scientists, managers and scientists involved in the development of therapeutic oligonucleotides in pharma and biotech companies.