Regulatory Affairs Essentials

Increase your understanding of the essential U.S. medical device regulations, including device classification, organizing pre-market notification 510(k), and planning and submitting a Pre-market approval (PMA). Enhance your knowledge of topics that include: global vigilance requirements and labeling requirements, European Medical Device Directive 93/42/EEC (MDD), E.U. conformity assessments, meeting E.U. essential requirements, and developing a technical file for the E.U. Get a review of device registrations in Canada, Australia, Japan and Latin America.

This course presents a detailed overview of the regulatory requirements for the development and manufacture of pharmaceutical products. Individuals involved in manufacturing, quality control, research and development, and clinical studies will learn the latest information. Explore topics that include the product development process through commercialization; product characterization and pre-clinical evaluation; pharmaceutical industry requirements; clinical trial requirements, good manufacturing practices (GMPs); good laboratory practices (GLPs); FDA inspections, labeling, and advertising of medical products; and preparing Food and Drug Administration (FDA) submissions.

Learn how to organize your medical product design teams to meet the stringent FDA requirements and Regulatory Affairs. This course has two phases, concept review and evaluation review, that provide baseline knowledge on the role of a regulatory affairs professional. Participants learn how to guide medical product designers through the design and development stages based on product classification to demonstrate safety and efficacy or performance for human use; and regulatory approval. Participants will be guided on how to conduct pre-submission meetings with the FDA , how to request meetings with the FDA, prepare and send pre-IDE packets, and how to record and document meetings with the FDA.

Learn how to continuously evaluate and perform periodic reporting on the safety, effectiveness, and reliability of a medical device for it's intended use. Utilizing design controls practices and procedures, participants learn "design transfer" from research and development to manufacturing. Increase your knowledge on managing regulatory affairs activities for engineering design modifications, post approval studies, and after market product changes. Participants learn how to recognize the regulatory pathway for changes in labeling, manufacturing process, design, sterilization, packaging, material and vendor; changes due to customer complaints, product recall or field corrective action.

Getting your medical product to market successfully starts before product design and does not end with the product launch. This course focuses on what is needed to successfully market products within medical device and related industries. Learn how to analyze the market, identify and understand customers and users in medical marketing industries, and provide them with value through innovation, sales and service. Case studies and insights from practicing medical product professionals enhance the application of classroom concepts.

Explore some of the most common intellectual property (IP) issues faced by engineers, managers and other professionals working in the high technology industry. Gain the knowledge of IP law that will help you plan and organize an effective IP portfolio. Learn about topics that include recognizing different types of IP, identifying protectable intellectual property, minimizing the risk of infringing a competitor's patent, and maximizing patent value through licensing or enforcement. Case studies and guest speakers augment the course lectures.

Recent publicity involving medical device and pharmaceutical products has heightened public awareness and triggered changes in the regulation and marketing practices of many healthcare product companies. Learn how to analyze and review potential response scenarios to various threats impacting a medical company's product, brand, marketing strategy and financial performance. Role play exercises and case study analysis prepare participants for real world medical product crisis management situations in the current and future regulatory and marketing environment.

Technology reimbursement is an essential step in successful medical product development. A well-constructed reimbursement strategy is a 'must-have' for venture capital investment, and reimbursement decisions by insurers can make or break a product launch and lead to significant product adoption or a failed sales strategy. This course will teach the basics of U.S. reimbursement along with tried and true strategies to obtain favorable decisions and gain product adoption even when reimbursement is not an option.