A 3-Day Intensive Continuing Education Course (1.8 CEUs)

About this course:

Time to market is crucial for the economic success of any new product. Yet, before a new therapeutic may be marketed, companies have to meet a significant number of regulatory requirements that proof to regulatory authorities that the new therapeutic is safe and efficacious and that it can be produced to predetermined specifications by a reliable manufacturing process.
This course clarifies the unique policies and expectations of FDA‘s Centers for Biologics Evaluation and Research (CBER) and Drug Evaluation and Research (CDER) with the goal of helping companies anticipate, and thus avoid, regulatory problems which have the potential to delay product approval. Specific CBER/ CDER manufacturing concerns, the locations of potential “red flags” in applications, common shortcomings in clinical trial design, and regulatory issues which can result in an IND being placed on clinical “hold” will be addressed.
At the end of this course you will know how to most effectively communicate with FDA and what information the Centers expect in an IND and the NDA/BLA. You will also have a solid understanding what to expect during regulatory inspections.

THIS COURSE WILL IMPROVE YOUR KNOWLEDGE...

• of the biologics regulatory process at CBER and

• of the biopharmaceutical regulatory process at CDER

• how CBER and CDER review IND‘s, NDA’s and BLA‘s

• what CBER and CDER expect in product applications

• of the laws and regulations governing approval of biologically derived products

• how to prepare an IND and a NDA/BLA

• what to expect during a regulatory inspection

• how to effectively interact with FDA to enhance your credibility and minimize disputes

• of how the transition of recombinant products from CBER to CDER is managed and how it will effect you and your company

YOU WILL BENEFIT FROM THIS COURSE, IF YOU…

• are the responsible manager for the development of a biologically-derived product.

• are a member of the Regulatory Affairs Department.

• are involved in planning the preclinical toxicity testing of a new biological product

• are involved in planning the Clinical Trial of a new biologically-derived product.

• are involved in preparation of the Technical or Clinical sections of an IND or a BLA.

• belong to the Quality Assurance or Quality Control Department of a biologics manufacturer.

• are responsible for regulatory compliance.

• simply need a thorough understanding of the U.S. regulatory process.