course offers extensive examination of the FDA’s regulations for biological
products from preclinical testing to post-marketing regulatory
requirements. Specific ethical and
regulatory considerations are discussed for various biological therapeutics
such as gene therapy, vaccines, protein, antibodies and stem cells. FDA’s regulation and policy updates for
regenerative medicine including stem cell treatments, tissue engineering, and
gene therapies are reviewed as well as updates on policies regarding
regenerative combination products and devices.
- Review preclinical and clinical development
phases for biological products
- Review FDA’s regulatory approvals
process for biologics
- Discuss FDA guidance documents and
most recent policy updates for regenerative medicine and stem cell
- Review applicable Good Manufacturing
and Good Laboratory Practices
- Discuss product labeling, marketing,
- Discuss post-licensure requirements
- Project Managers and Team Leaders
- Staff from Pharmaceutical Companies
or Contract Research Organizations (CROs) involved in biologics trials
- New Clinical, Regulatory, and
Department Staff who will design biologics clinical trial programs
The course will be led by one of the following
Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC
Click here for complete trainer
Day One: 8:30 a.m. – 5:00 p.m.
- What is biologic?
- Preclinical safety assessment of therapeutic proteins and
- The Biological IND review process in CBER and CDER
- Clinical testing of biologically derived therapeutics
- The clinical evaluations of preventive vaccines for infectious
- FDA regulatory approvals for regenerative treatments and stem
- FDA guidance documents for stem cell technologies
- Global approval of stem cell technologies
Two: 8:30 a.m. – 5:00 p.m.
- How to design appropriate clinical trials for biologics
- The Biological License Application (BLA) and review process
- Regulations for regenerative products as medical devices,
- Applicable Good Manufacturing and Good Laboratory Practices
- Product labeling, marketing, and advertising
- Post-licensure requirements
- Bioresearch Monitoring Program for biologics
- Biologics Quality by Design (QBD) Case Study:
Application of Quality Risk Management (QRM) perspectives to develop
baseline quality metrics and Key Risk Indicators (KRIs)
fees include assorted breakfast items that will be available each day ½ hour
prior to the start of the seminar. Also included is a Networking Lunch that
will be served each training day.
Special rates are available for
multiple attendees from the same organization.
Contact Melissa Dolen at 781-972-5418 to discuss your options and take
advantage of the savings.
Click here for our seminar
Barnett International is accredited by the
Accreditation Council for Pharmacy Education as a provider of continuing
pharmacy education. Participants will
receive 15 hours (1.5 CEUs) of continuing education credit for full
participation, including the completion of a pre-test, post-test, and program
evaluation. Barnett International will
issue a receipt of completion for earned CEUs within three weeks of program
completion. ACPE#: 0778-0000-18-060-L01-P.
this course at your company! For more information, contact Naila Ganatra at +1