Each year, the PDA/FDA Joint Regulatory
Conference provides a forum for the medical
products industry to identify, discuss,
and explore its unique challenges and
opportunities. This conference addresses
product quality, lifecycle management, innovation
and regulatory developments for
effectively delivering future medicines and
Conference sessions engage regulators,
their industry colleagues and other stakeholders
in dialogue on topics of mutual
interest. The meeting also explores how
the US FDA regulates drugs, devices and
biologics such that products can be moved
to patients more quickly while also maintaining
the gold standard for safety and
effectiveness established by the Agency.
The 2017 conference will look at “Ensuring
Product Quality in an Era of Innovative
Therapies.” This year, advanced
therapies such as cell and gene therapies,
including regulations and submission
expectations, will be a topic of discussion,
as will combination products. Both are
timely subjects for attendees.
Modernization of regulations and advances
for innovative initiatives, such as cancer
research, regenerative medicine, and continuous
drug manufacturing will also be
examined. Likewise, efforts to encourage
integration of patient perspectives into the
decision-making processes for drugs and
devices will also be highlighted.
Industry endeavors to monitor quality
control systems and processes and drive
continuous improvement in drug manufacturing
will also be explored.
In addition, attendees can look forward
to the usual set of updates from each of
the medical product areas within FDA on
program-specific initiatives. The newly
launched regulatory track session, to be
held on Day 2 of the conference, will
allow attendees to hear presentations
directly from the Agency’s review staff
regarding quality assurance and regulatory
considerations for new drugs.
Join your colleagues this September in
Learn more about the 2017 PDA/FDA Joint Regulatory Conference and subsequent PDA Education courses.