To be successful and stay
competitive, pharma and biotech companies often look to expand into new
markets. Expansion introduces new challenges with regulatory compliance and
data integrity regardless of expansion type. Tracking and locating all the key
pieces of information needed to successfully launch in new markets can be
time-consuming and error prone. Often, nuances of regulations and specific
requirements are missed when they vary so greatly in each potential
market. You need a strategic advantage
to increase your success and compliance in new markets.
Join
us for a regulatory professional’s presentation on Managing Global Regulatory Complexity: Five Strategies to Optimize
Regulatory Compliance in New Markets.
Learning Level:
Intermediate: Content is designed based upon
the assumption that individuals have basic knowledge of the topic(s) and/or
demonstrated competence related to the topic(s). Higher-level concepts are
introduced during lectures; exercises requiring synthesis and/or application of
concepts are incorporated into the activity.
Learning
Objectives
Upon the webcast's
conclusion, you will have learned about:
·
Regulatory
complexity and requirements of divergent markets
·
Common
challenges in establishing relationships with local regulatory bodies
·
Considerations
for inspection, stability requirements and track-and-trace systems
·
Proper
vetting of reimbursement policies and protection of intellectual property
·
Best
practices to optimize regulatory compliance in new markets
Who Should Attend?
·
Regulatory Affairs Professionals with more
than 5 years’ experience
·
RA managers and directors
·
QA managers and directors
Webcast registration
includes access to handouts, presentation slides and the on-demand recording
for one year.