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Certificate in Regulatory Affairs in a
Technical Environment

Today it is essential that employees in the pharmaceutical, biotech, and medical device manufacturing companies – or related fields – understand the regulatory environment in which they work. Whether it’s for better performance or career development, employees in these industries need to know how and why their products make it to the marketplace – or how and why they get rejected. What is the FDA? How does it operate? What are the regulations and FDA requirements that must be met in order to manufacture and market a drug or a vaccine…a medical device? What is the process and timetable, and what are the strategies that can be used to get a product to market in the least amount of time? …your patent is expiring—tick, tick, tick. Finally, what are the risks and costs of non-compliance? (Hint – they’re huge!)

Regulatory Affairs is a technical subject. Your background in chemistry or chemical engineering will help you write the FDA-required protocols on pilot plant operations, on quality control procedures, or on impurity profiles of drug substances.

This graduate level certificate program has been developed for employees working in pharmaceutical, biotech, and medical device manufacturing companies and dealing with regulatory and FDA issues in the workplace, those in the legal profession working with FDA law and regulations, and others interested in the field. Students will gain a general understanding of the Regulatory Affairs environment, a broader understanding of the FDA and how it works, an understanding of FDA requirements covering the manufacture of drugs and vaccines, the risks and costs of non-compliance, and an understanding of the process, timetable and strategies used to get a product to market.

Courses

Four courses (12 credits for credit participation) are required to complete this certificate and students will take any four of the following for certificate completion (courses may be taken in any order, subject to scheduling)

Additional Notes about the Required Courses:

Learning Options

Certificate Participation: All courses offered may be taken for Lehigh academic credit only by students admitted to Lehigh University.

Course Descriptions:

CHM 425 (3 credits)-Pharmaceutical Regulatory Affairs I – Discovery to Approval

This course covers the stages of the drug approval process and how these relate to the laboratory activities that provide the scientific basis for the New Drug Application (NDA). Lectures treat drug discovery, chemical process development of the active pharmaceutical ingredient (API), and pharmaceutical process development of the drug product. Regulatory issues in screening and testing, the management of the preclinical trials, and the management of clinical trials will be covered. The regulatory requirements for the production of the drug substance (API) from bench to pilot plant to full-scale manufacturing will also be covered. Included in the discussions will be Good Laboratory Practices (GLPs) and Good Manufacturing Practices (GMPs). The regulatory issues concerning the use of Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) are also covered as well as the processes for approvals of diagnostics and devices. All topics are presented by practicing professionals in the regulatory affairs area.

CHM 428 (3 credits)-Pharmaceutical Regulatory Affairs II –Biomarkers (3)

Regulations have set in motion the use of Biomarkers as a key element for pharmaceutical development. Biomarkers will become a method to demonstrate safety and efficacy of experimental drugs during human trials. This course will review the history of Biomarker and Medical Device law/regulations in the United States. It will also define the current scientific requirements for Biomarkers to meet new regulations. Case studies will provide examples for the use of Biomarkers in pharmaceutical development.

CHM 442 (3 credits)-Pharmaceutical Regulatory Affairs III – Validation of Analytical Assays

This course will cover topics such as Introduction to Analytical Terms and Concepts, Regulations for Pharmaceutical Analytical Laboratories (both Food and Drug Administration and the International Conference on Harmonization), Setting and Evaluating Instrument Performance Criteria, Instrument Acceptance, and Assay Design and Validation. Specific examples for assay design and validation, especially for HPLC are given. (Prerequisite: students should possess a background in principles of analytical chemistry plus one semester of organic chemistry or permission of the instructor)

CHM 463 (3 credits)-Pharmaceutical Regulatory Affairs IV – Commercial Production, Validation, and Process Qualification

This course will address the last portion of successful commercialization which involves the manufacture of pharmaceuticals. Underlying regulations and principles will be followed by examples. Students will cover related topics from the text and lectures. In addition, subjects such as Process Analytical Technologies (PAT), Facility Design, Manufacturing of Potent Compounds, Customer Complaints, Product Recall and Change Control will be addressed.

CHM 474 (3 credits)-Pharmaceutical Regulatory Affairs V – Introduction to Pharmaceutics

There is a saying in medicinal chemistry circles that “a clever crew in the pharmaceutics group can buy you two logs on the clinical potency of your lead compound.” How a drug substance is formulated, how it is stabilized, how it is delivered, and how it is released for systemic availability, are key factors in whether you have a marketing success or just one more dead (but once promising) therapeutic candidate. It is often true that the IC50 – and the apparent clinical dose – of the best drug substance leaving the synthetic organizers’ hands, can be improved by pharmaceutical optimization. This course is taught from an applications perspective by practitioners in the field and covers the analytical and physical chemistry of drug development.

CHM 477 - Regulatory Affairs VI - Biologics

Bio-macromolecules are regarded as the most promising therapeutics of the 21st century, supplementing the long established small molecule organic drugs. Whether poly-peptide, poly-nucleotide, or even poly-saccharide, properly designed, tested, and registered (with FDA) bio-macromolecules can regulate blood pressure, glycolysis, immunity, pain, malignancy, inflammation and a host of other human dysfunctions. Since the first biopharmaceutical approval in 1982 the biotechnology derived product market has been rapidly growing with introduction of a number of promising advances in medicine such as therapeutic monoclonal antibodies (humanized and fully human MABs), cancer vaccines, cytokines, anti-sense technology, interference RNA, and growth factors. As with traditional drugs (small molecules), the regulatory framework for approval of a biotechnology derived product (biologics) is complicated. In addition, there has been much debate about the introduction of follow-on-biologics (FOBs) or biosimilars using an abbreviated approval process. An overall biologics-based process map beginning with pre-clinical through the post-marketing stage will be discussed. Topics such as therapeutic proteins/peptides, gene therapy, stem cells, vaccines, interference RNAs, PK-PD, world-wide regulatory filings, preclinical IND-enabling studies, BLA/CTD filing, FOBs biologics, immunogenicity, comparability studies, manufacturing challenges, clinical trials, market exclusivity, and regulatory guidelines related will be discussed.

CHM 477 - Regulatory Affairs VII - Chemistry Lab to Clinical Trials

Using basic biochemistry data, preclinical data, and the key documentation outlining results, this course covers how the clinical protocol is designed and how the trial is monitored. The use of transitional biomarkers, genetic analyses, PK/PD, dose-limiting toxicities, immunogenicity, imaging, and drug- drug interactions observed in preclinical studies serve as guideposts to the design of an optimum clinical protocol. The integration of chemistry, biology, and medicine proves essential to formulation of the first-in-man clinical study. The pathway from the chemistry lab to the clinic will be detailed with a focus on early development phase trials.