Biologics Development and Regulations

EARLY REGISTRATION
Course #: SBDD0918
September 20-21, 2018 | San Diego, CA
8:30 AM - 5:00 PM Eastern
San Diego Solamar
Take advantage of our $1675.00 price by registering early!
* After Thursday, August 16, 2018, costs are $1875.00.
*
$1,675.00

Take advantage of our $1675.00 price by registering early!
* After Thursday, August 16, 2018, costs are $1875.00.

Course Description

 

This 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.

Learning Objectives

  • 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 technologies
  • Review applicable Good Manufacturing and Good Laboratory Practices
  • Discuss product labeling, marketing, and advertising
  • Discuss post-licensure requirements

Who Should Attend

  • 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

Instructor

The course will be led by one of the following instructors:

Marina Malikova, Ph.D., MSci, M.A., C.C.R.A., RAC

Click here for complete trainer biographies

Course Outline

Day One: 8:30 a.m. – 5:00 p.m.

  • What is biologic?
  • Preclinical safety assessment of therapeutic proteins and monoclonal antibodies  
  • The Biological IND review process in CBER and CDER  
  • Clinical testing of biologically derived therapeutics  
  • The clinical evaluations of preventive vaccines for infectious disease indications
  • FDA regulatory approvals for regenerative treatments and stem cell-based therapies  
  • FDA guidance documents for stem cell technologies  
  • Global approval of stem cell technologies  

Day 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, combination products  
  • Applicable Good Manufacturing and Good Laboratory Practices  
  • Product labeling, marketing, and advertising
  • Post-licensure requirements  
  • Bioresearch Monitoring Program for biologics  

Interactive Activities

  • Biologics Quality by Design (QBD) Case Study: Application of Quality Risk Management (QRM) perspectives to develop baseline quality metrics and Key Risk Indicators (KRIs)

Registration Fees

Registration 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 cancellation policy

Accreditation Information

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. Released: 9/18.

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.