[three_fourth]
[image src=”/wp-content/uploads/2018/11/biologics-biosimilars-simulation-620-1.png” width=”620″ align=”left”]
[h2]Course Overview[/h2]
This course provides a brief history of biologics and follow-on biologics (also known as biosimilars) and how they are regulated, and describes the key aspects of chemistry, manufacturing and controls (CMC) for various types of biologic products. It defines principles underlying biologics clinical trial assessment, IND/BLA regulations, and aids in a planning strategy for toxicology and clinical studies supporting biological drug development. Students will participate in interactive BLA simulation workshops, forming company project teams – working together to get their product approved with the required label, and within the projected timeline and budget. Participants will gain a broad multidisciplinary understanding of the scientific, management and regulatory decision points in the development of new biologics.
[h3]Download the final agenda for PERI’s Biologics and Biosimilars comprehensive course.[/h3]
[space height=”5″]
[h3]Benefits of Attendance[/h3]
[icon_list type=”triangle”]
- Learn the history of biologics and how they are regulated
- Walk away with an understanding of the preclinical studies used to support the phases of clinical trials
- Work with peers to develop a strategy for developing new biologics, from first in human to product launch
- Learn from FDA and industry experts about biologics and biosimilars
- Experience submitting a Biologic License Application via an interactive simulation
[/icon_list]
[tabs]
[tab title=”Educational Objectives”]
[icon_list type=”triangle”]
- Illustrate the differences between small molecules and biologics in terms of regulatory pathways to approval
- Distinguish the differences between biologics and biosimilars
- Describe the manufacturing process of biologics
- Construct key components of pre-clinical packages required for regulatory approval of biologics
- Practice compiling the requirements for submitting a Biologic License Application (BLA)
- Analyze the utility of biomarkers in the development of biologics, including oncology products
[/icon_list]
[/tab]
[tab title=”Key Topics”]
[icon_list type=”triangle”]
- The History of Biologics
- The IND/BLA Regulatory Procedure
- Chemistry, Manufacturing and Controls
- Biologic License Application Simulation Workshops
- Special Topics in Toxicology
- Overview of Clinical Trial Design
- Immunogenicity
- “Getting your Biologic into Humans” Workshop
- Perspective on Preventive Vaccine Trials
- Managing the Development Process through Multidisciplinary Project Teams
- Marketing Authorization Application (MAA)
[/icon_list]
[/tab]
[tab title=”Who Should Attend”]
[icon_list type=”triangle”]
- Clinical and Nonclinical Professionals
- Manufacturing Personnel
- Regulatory Affairs Professionals
- Seasoned drug developers transitioning into biologics
- Pharmaceutical Pharmacists
[/icon_list]
[/tab]
[tab title=”Continuing Education”]
Continuing Education Credit
Pharmaceutical Education & Research Institute, Inc. (PERI) is pleased to make continuing education credit available to you for attendance at this program. To receive credit, you must attend the entire program and submit the Continuing Education Application form directly to a PERI on-site coordinator. Additional $35 fee applies for students who are applying for continuing education credit.
ACPE Statement:
Pharmaceutical Education & Research Institute, Inc. (PERI) is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. ACPE Universal Activity Number is 0708-0000-19-001-L01-P. 1.3 continuing education units (CEUs) are available for this program. Initial Release Date: 03/04/19. This is an application-based CPE Activity.
[clear]
[clear]
ACCME Statement:
PERI, Inc. is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians. PERI, Inc. designates this live activity for a maximum of 13 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
[clear]
[clear]
[/tab]
[/tabs]
[clear]
[h3]PERI Faculty List[/h3]
Noel Cusack, PhD
Independent Consultant, Nonclinical Development
Christopher Ellis, PhD
Pharmacologist
Division of Anti-Viral Products
US Food and Drug Administration
Martin Green, PhD
Supervisory Toxicology
Division of Vaccines and Related Product Applications
US Food and Drug Administration
Melanie T. Hartsough, PhD
Independent Consultant
Orest Hurko, MD
Alnylam Pharmaceuticals
Tufts Center for Study of Drug Development
[h3]Commercial Support[/h3]
In-kind financial support (faculty’s time) has been provided by the following companies:
– Avalere Health
[/three_fourth]
[one_fourth_last]
[h3]Event Details[/h3]
Date: March 4 – 5, 2019
Location: PERI Training Facility
9302 Lee Highway, Fairfax, VA 22031
Course Rate: $1695
This course has concluded.
[h3]Request a Proposal[/h3]
Interested in bringing this course to your company? Request a proposal and a PERI team member will be in touch about hosting this course as a Corporate Education program.
[button_medium color=”orange” url=”/corporate-education/request-a-proposal/”] Request Proposal[/button_medium]
[space height=”20″]
[h4]Course Information[/h4]
Jo Ann Zoul
571-490-8409
[button_small color=”slate” url=”mailto:jzoul@peri.org”]Email Question[/button_small]
[/one_fourth_last]