• Understand the important unique CMC regulatory compliance challenges of biopharmaceuticals and biologics, and how this leads regulatory agencies to have different CMC regulatory requirements for biopharmaceuticals and biologics compared to pharmaceuticals of chemical origin

• Develop a cost-effective, risk-managed, clinical phase-dependent CMC regulatory compliance strategy to move these products through each stage of clinical development (from Phase 1 through Phase 3) and into commercialization, and how to maintain CMC regulatory compliance once market approval has been obtained

• Effectively communicate with regulatory authorities, both verbally and with written submissions, on significant biopharmaceutical and biologic CMC regulatory issues, and how to prepare CTD-formatted Modules 2.3 and 3 for biopharmaceuticals and biologics

Course Description

With the rapid development and constantly changing Chemistry, Manufacturing & Controls (CMC) landscape of biopharmaceutical and biologic products and their manufacturing process technologies, coupled with ongoing changes in compliance regulations, it is most important for a company to have an effective strategy to achieve CMC compliance.  At each stage of drug development, from Phase 1 through market approval, the basic question needs to be addressed:  ‘What is absolutely necessary from a CMC regulatory compliance perspective to be successful in getting our biopharmaceutical/biologic through the clinical trials and onto the market?’ 

CMC regulatory compliance deficiencies have resulted in clinical holds and delays in market approval.  CMC regulatory compliance deficiencies of marketed products have also resulted in FDA Warning Letters and product recalls.  Insights and practical suggestions to develop and manage CMC regulatory compliance for biopharmaceuticals and biologics are offered in this course. 

This three day course will also present a strategy to obtain a cost-effective, risk-managed, clinical phase-dependent CMC regulatory compliance especially useful for all stages of clinical development and for those biopharmaceutical and biologic products already on the market.  This course also includes a discussion on preparing the CMC sections for both clinical trials (IND and IMPD) and a market application dossier (BLA/NDA/MAA) using the ICH Common Technical Document (CTD)-formatted Modules 2.3 and 3 for biopharmaceuticals and biologics.




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Past Participants' Comments

"This is the most valuable course I have taken in many years. I will be applying what I learned to my current project immediately. The information could not have come at a better time for me. Every section was valuable, my classmates and I stayed for all of it!"
Duane V., Program Director, Hoffmann-LaRoche
 
"I thought the Course Director did an outstanding job of giving a detailed overview of CMC issues.  The course was rich with practical information and his examples made the information more interesting.  Thanks!
Dana A., Consultant, The Vaccine Company

“This was the first course that totally deals with all CMC issues from Phase I through to BLA/NDA filing.  I would recommend this course to any start-up biotechnology company on how to design your CMC strategy.” 
Warren D., QA Manager, Progen Industries

“There was a good management of time; a provision of applicable hands on exercises; good slides with reference and easy to follow format!  It was clear and organized verbally and document-wise with good distinction and highlighting of main points..”
Grace K., RA Assoc., Amylin

“Small classroom format is very beneficial to learning.  As a result classroom dynamics were excellent.  Participants felt free to ask questions during the presentation and the ensuing discussions were beneficial to all attendees.  Also, the course director was approachable and answered each question without dismissing seemingly obvious ones.  He understood the diverse disciplines from which the attendees came.” 
Maureen M., Manager, Regulatory Affairs, Merck Frosst Canada

"The course director was excellent and is extremely knowledgeable in regards to CMC for biopharmaceuticals/biologics. He presented various examples from his experience and answered all questions thoroughly."
Nisha P., Associate Manager, QA Compliance, Centocor

 "This course provided a thorough broad understanding of the CMC Regulatory process.  I would highly recommend this course to any technical person who is involved in preparing CMC documents."
Steven M., Senior Program Manager, Bristol-Myers

 “The organization of the course material gave the proper foundation from topic to topic.  Emphasis on critical development issues to avoid delays in the approval of the application were well discussed and rationalized.  As someone with no prior Biologics regulatory background I found this a very good introduction to the complexity of the requirements for BLA/NDA submissions.”
David L., Director Regulatory Affairs, Forest Laboratories

 “Real improvement of my knowledge through this three day course thanks to the experience and the quality of the instructor.  Thank you for concrete advice regarding my own projects.”
Lehmann C., Team Manager, Sanofi-Aventis

 “Good in-depth course covering all facets of CMC with biopharmaceutical focus - which is hard to find!”
Greg S., QA Manager, GSK

 “This course is a precise overview of current CMC regulatory requirements and approaches taken by industry to meet agency regulations.  Instructors presentation of the topic under the theme of “CMC  continuation” was excellent.”
Prakash S., Assoc. Director, Enzon Pharmaceuticals