Companies face constant
pressure to meet the increasing regulatory expectations and demands for
information. Data identification through Systematic Literature Review (SLR)
supports critical regulatory functions throughout the company, from MDR
requirements through IND submissions.
In this session, we will
review:
- How
the use of published data can support regulatory expectations
- When
to conduct a systematic literature review
- Best
practices for conducting a methodologically-sound SLR
- The
tools and technology available for SLR
- Real world case
studies about leveraging SLR
Learning
Objectives
Upon conclusion of the program, you will be able to:
- Understand how
published data can be used to support regulatory expectations
- Determine when to
conduct a systematic literature review
- Understand the
best practices for conducting a methodologically-sound SLR
- Have knowledge of
using the available SLR tools and technology
Who Should
Attend?
- Anyone utilizing
literature review for regulatory submissions or data identification, from
entry-level to experienced professionals.
Speaker
- Laurie Mitchell,
president, Criterion Edge
Laurie Mitchell is Founder and President of Criterion Edge, a global medical and regulatory writing and safety services firm serving the medical device, pharmaceutical, and biotech industries. Laurie has over 20 years of experience in medical writing, safety and pharmacovigilance management, and regulatory reporting.
Having provided regulatory solutions to many pharma and medical device companies, both large and small, she is a proven leader in designing practical strategies to meet current global regulatory challenges. Laurie is a published author, and holds a Master of Nursing from UCLA.
Webcast registration
includes access to handouts, presentation slides and the on-demand recording
for one year.