Brochure Regulatory Affairs

2020 REGULATORY AFFAIRS ONLINE CERTIFICATION COURSE THE COURSE WILL PROVIDE YOU WITH AN ESSENTIAL OVERVIEW OF THE CRITICAL AREAS OF PHARMACEUTICAL REGULATORY AFFAIRS IN THE MIDDLEEAST.

DIRECTORY 01 COURSE OBJECTIVES 02 COURSE DESCRIPTION 03 COURSE CURRICULUM 04 LEARNING OUTCOME

OBJECTIVES OF COURSE REGULATORY AFFAIRS KNOWLEDGE This course will help students to develop up-to-date knowledge of regulatory issues process and legislation, especially in the UAE and Gulf region. CARRIER DEVELOPMENT The Pharmaceutical Regulatory Affairs Certificate provides a cost-effective, convenient option that will equip the students to progress as a regulatory professional and stay ahead of the competition during selection process. CERTIFICATION This is an accredited professional certification course, which will give you sound knowledge of regulations along with certification in field of regulatory affairs.

COURSE DESCRIPTION WHAT IS REGULATORY AFFAIRS? As a discipline, regulatory affairs cover a broad range of specific skills and occupations. Under the best of circumstances, it is composed of a group of people who act as a liaison between the potentially conflicting worlds of government, industry, and consumers to help make sure that marketed products are safe and effective when used as advertised. People who work in regulatory affairs negotiate the interaction between the regulators (the government), the regulated (industry), and the market (consumers) to get good products to the market and to keep them there while preventing bad products from being sold. The range of products covered is enormous, including foods and agricultural products, veterinary products, surgical equipment, and medical devices, in vitro and in vivo diagnostic tools and tests, and drugs (which range from small molecules to proteins). The range of issues addressed is huge, such as manufacturing and analytical testing, preliminary safety and efficacy testing, clinical trials, and post marketing follow-up. Advertising issues, with a healthy dose of data management, document preparation, project management, budgeting, issue negotiation, and conflict resolution, are thrown in the mix. REGULATORY AFFAIRS Over the years, a complicated system of checks and balances has developed to set in place a process to regulate the marketing of products efficiently and effectively.

COURSE CURRICULUM MODULE-1 REGULATORY AFFAIR INTRODUCTION The regulatory function in healthcare industries is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals. MODULE-2 REGULATORY AGENCIES WORKING ACROSS THE GLOBE In the present scenario, pharmaceuticals are considered as the most highly regulated industries worldwide. The regulatory body ensures compliances in various legal and regulatory aspects of a drug. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate drug development process, licensing, registration, manufacturing, marketing, and labeling of pharmaceutical products. MODULE-3 SMPC AND LABELING In the 1970s, the US Food and Drug Administration (FDA) set a series of regulatory steps in place to ensure labeling on prescription drugs were clear and concise. Today, British patients are protected by the Medicines and Healthcare Products Regulatory Agency (MHPA), the agency that determines the industry standard for medicine labeling. However, it is not just patients that benefit from clear medication labeling. Admittedly, almost every industry sector has strict standards associated with packaging and labelling.

COURSE CURRICULUM MODULE-4 OVERVIEW OF DRUG MASTER FILE Drug Master File (DMF) is a confidential, detailed document submitted by Active Pharmaceutical Ingredient (API) manufacturers to the Regulatory Authority. A drug master file is filed when two or more firms work in partnership on developing or manufacturing a drug product. Drug substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient (21 CFR 314.3 (b)). MODULE-5 IMPURITIES PROFILE OF DRUG SUBSTANCE (ICH Q3A) There is an ever-increasing interest in impurities present in APIs. Now days, not only purity profile but also impurity profile has become mandatory according to various regulatory authorities. In the pharmaceutical world, an impurity is considered as any other inorganic or organic material, or residual solvents other than the drug substances, or ingredients, arise out of synthesis or unwanted chemicals that remains with APIs. MODULE-6 US DRUG MASTER FILE Drug master files (DMFs) are submissions to FDA used to provide confidential, detailed information about facilities, processes, or articles used. a. Type I: Manufacturing Site, Facilities, Operating Procedures, and Personnel. b. Type II: Drug Substance, Drug Substance Intermediate, and Material Used. c. Type III: Packaging Material. d. Type IV: Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation. e. Type V: FDA Accepted Reference Information.

COURSE CURRICULUM MODULE-7 EU DRUG MASTER FILE & CEP (CERTIFICATE OF PHARMACEUTICAL) The main objective of the Active Substance Master File (ASMF) procedure, formerly known as the European Drug Master File (EDMF) procedure, is to allow valuable confidential intellectual property or 'know-how' of the manufacturer of the active substance (ASM) to be protected, while at the same time allowing the Applicant or Marketing Authorization (MA) holder to take full responsibility for the medicinal product and the quality and quality control of the active substance. National Competent Authorities/EMA thus have access to the complete information that is necessary for an evaluation of the suitability of the use of the active substance in the medicinal product. MODULE-8 STABILITY STUDIES AND POST APPROVAL STABILITY COMMITMENT Regulatory requirement in term of API file submission and approval - International Guideline (ICH Q1E) - Regional Guideline Information on the analytical procedures used to generate the data and validation of these procedures. MODULE-9 PHARMACEUTICAL DEVELOPMENT REPORT A brief summary describing the development of the drug product, taking into consideration the proposed route of administration and usage: - Parameters relevant to the performance of the drug product and optimization of the manufacturing process - Suitability of the container closure system used for storage, transportation and use of - Selection of drug product - The microbiological attributes of the dosage form

COURSE CURRICULUM MODULE-10 PROCESSES AND VALIDATION - REGULATORY ASPECTS Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. Description, documentation, and results of the validation &/or evaluation studies of critical steps used in the manufacturing process. MODULE-11 NON-CLINICAL, CLINICAL TRIALS AND REGULATORY AFFAIRS Nonclinical trials - The toxicological studies, Dossier requirement, Published literature requirement: Clinical trials - EU Developing a Clinical Regulatory Strategy, US INDs - Content and Process the Clinical Dossier, Regulatory Input Product Labelling, History of regulation of clinical trials GCP, Pharmacovigilance for Clinical Trials in the EU Manufacture, GMP and labelling of IMPs The clinical trial protocol The IMPD CTA amendments, CTA annual reports and end of study notifications, Complexities of clinical trials, GMP Aspects of Clinical Trials. MODULE-12 BIOEQUIVALENCE STUDIES Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes.

COURSE CURRICULUM MODULE-13 REGULATORY SUBMISSION STRATEGIES Dossier formats and other fundamentals. GCC requirement for dossier submission. The data requirements for each application will differ, depending on the drug submission type. However, all the required data should be in accordance with the CTD structure (i.e. applicants should not modify the overall organization of the CTD as outlined in the guideline. MODULE-14 REGULATORY NEGOTIATION Writing and Negotiating - Basics of Negotiating Regulatory Negotiating Negotiating from a Weak Position Making Your Strategy Clear Risk Management What is risk management Risk Technique? Regulatory Risk Management MODULE-15 PHARMACOVIGILANCE A brief summary describing the development of the drug product, taking into consideration the proposed route of administration and usage: - Parameters relevant to the performance of the drug product and optimization of the manufacturing process - Suitability of the container closure system used for storage, transportation and use of - Selection of drug product - The microbiological attributes of the dosage form

COURSE CURRICULUM MODULE-16 PRODUCT LIFE CYCLE MANAGEMENT Pharmaceutical lifecycle management (LCM) is the process of managing the entire lifecycle of a product including its research, design and manufacture, service, and disposal.

LEARNING OUTCOME Outcome of this course is development of regulatory affairs knowledge, skills, and competencies. KNOWLEDGE • Up to date knowledge of regulatory process and legislation especially in the UAE and Gulf region • Dossier format and submission requirements in GCC region. • Understanding on Rapid advancement in product safety, regulatory, compliance. SKILLS • Dossier Submission • CTD dossier formatting • Application processes • Negotiation skills COMPETENCIES • Regulatory strategies • Regulatory communications • Regulato1ry Comp2liance 3 4 5 6 7 8 9 10

ASESSMENT & CERTIFICATION • Students will be assessed through online quiz and assessment during virtual classroom sessions. • Students will receive an accredited professional certificate from Pharmento. ATTENDANCE Each candidate should attend all 16 online sessions of regulatory Affair course with examinations and 3 interactive virtual sessions to get certification in regulatory affairs.

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