In chemistry, manufacturing, and controls (CMC) regulatory writing, there is a difference in the level of detail required for New Drug Applications (NDAs) and Biologic License Application (BLAs) supporting different types of products. The expectations tend to diminish as time elapses and the regulatory authority becomes more familiar with a specific type of medicinal product. Small molecule oral solid products have been submitted to and approved by regulatory authorities more frequently and represent a different set of expectations than are expected for vaccines and biologics. Vaccines and biologics tend to be rather comparable to each other yet they contain significant differences in requirements for certain modules. This program investigates the differences between the small molecule NDA, and the biologic and vaccine BLA. It will tie together the processes required for small molecules, biologics, and vaccines, including relevant information in a company’s regulatory applications, including pertinent regulatory guidelines and the synthesis, production, and/or manufacturing of the compounds and products.
This webcast will provide a high-level overview of the expectations required for Module 3 submissions for a small molecule oral solid product NDA, a parenteral biologic BLA, and a vaccine BLA. The program will start with the small molecule oral solid, progress to the biologic including a brief discussion of post approval changes, and finish with the vaccine.
- Assessment pathway for determining if user feedback surveys can be leveraged for your device.
- Understanding of the requirements of a scientifically valid user feedback survey, and where people commonly go wrong.
- Guidance on ensuring the surveys will meet notified body expectations around scientific validity and other requirements.
- Definition of the practical regulatory, ethical and data privacy considerations, to confirm your data will be acceptable to all regulatory authorities.
- Actionable information helping you to chart your course to having a successful PMCF plan and data for ongoing MDR compliance and CE marking.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
Upon the conclusion of the program you will:
- Understand the basic format of Module 3 for a small molecule, with a brief discussion of post approval changes for a small molecule oral solid.
- Recognize the inherent high level differences between a small molecule, biologic, and vaccine application, including both the content and format of individual modules.
- Be able to identify the potential regulatory hurdles that need to be overcome in the development of a vaccine.
Who Should Attend?
Recently, there have been significant changes in the requirements around human factors for medical devices. This workshop will provide practical guidance and information for:
- Regulatory affairs Specialists, Managers, Directors and VPs
- Post Market Surveillance Specialists, Managers, Directors and VPs
- Clinical Specialists, Managers, Directors and VPs
Nellie Waterland Forwood has more than 30 years of experience in the pharmaceutical industry (pre- and postapproval) as a CMC regulatory affairs professional. She is a certified Six Sigma Master Black Belt with proven expertise in the use of Six Sigma define, measure, analyze, improve, and control tools to improve processes and implement and maintain improvements. As a principal regulatory writer, Forwood has written various types of pharmaceutical CMC and clinical regulatory documents. She has experience in documentation preparation for pre-meeting briefing documents, Investigational New Drug Applications (INDs), Investigational Medicinal Product Dossiers (IMPDs), NDAs, and Marketing Authorisation Applications (MAAs) for large and small molecules with emphasis on regulations and electronic Common Technical Document (eCTD) requirements. Forwood also has experience in writing Clinical Study Protocols (CSPs) and Investigator’s Brochures (IBs).
James M. Zoshak, Associate Principal Regulatory Writer, Certara Synchrogenix
James M. Zoshak is an experienced CMC regulatory project manager, writer, and strategist, with more than 15 years of experience. In his role, he plans, organizes, writes, reviews, and edits CMC regulatory submissions and other relevant documentation in support of the registration of numerous small molecule, biopharmaceutical, and gene therapy products marketed across the globe. In addition, he worked on site as the primary liaison to one of Synchrogenix’s largest clients for ten years, and continues to liaise with Synchrogenix’s clients to ensure consistent, high quality support. Zoshak is familiar with all major market regulatory submission types, both pre- and postapproval, and has experience with assembling international dossiers. He also prepares responses to health authority questions; briefing packages for major submissions, FDA type C meetings, and European scientific advice meetings; and white papers on regulatory strategy and the science behind biologics and gene therapies. He has additionally been responsible for the construction and maintenance of submission libraries, dossier conformance guides, and databases tracking the interactions of global change control, supplement, and supporting documentation.
Eric Jacobson, Ph.D, Senior Regulatory Writer, Certara Synchrogenix
Eric Jacobson has worked in vaccine development across various capacities. In early-stage biotech, his focus was on therapeutic cancer vaccines, and he led initiatives in IND-enabling studies and oversaw relationships with contract manufacturing organizations (CMOs). As a consultant at a CMO, Jacobson performed process validation and scale-up activities for an oligonucleotide-based adjuvant, and at a large pharmaceutical company, he was on a team that was responsible for the development of a quadrivalent influenza vaccine. Currently, at Synchrogenix, his responsibilities include writing module 3 granules in support of vaccine IND and BLA submissions.