Certain trends and directions can be recognized
in the preparation of NDA/BLA/MAAs. The ICH
has the long-term goal of harmonizing the content
of European, US and Japanese NDA/BLA/MAAs.
EU registration dossiers are becoming more
detailed in the process, and are expected to include
integrated summaries in the future. The US FDA
will accept more non-US data for drug approval as
common high standards for clinical trials become
well established in the world. Finally, electronic
NDA/BLA/MAAs will be the norm and are already
required in the United States.
Lastly, how and where are Competencies
Taught?
Quite apart from established in-house training
programs, there is a wide selection of vendors
offering competency-based training. The format
of their programs may include:
workshops, seminars and lectures;self-instructional manuals;computer-based training systems;videotape libraries;job aids;preceptorships and mentoring programs;educational organizationssuchasPERI and DIA;professional meetings and conferences.Most vendors advertise widely in the trade
journals, and many of their courses are tailored
to meet the several certifications that are now
available in clinical research or regulatory affairs.3.3 COMPETENCY-BASED TRAINING PROGRAM FOR STAFF ASSOCIATED WITH CONDUCTING CLINICAL TRIALS 39