Master of Regulatory Affairs
Regulatory affairs (RA), also called government affairs, is vital in making safe and effective healthcare products available worldwide. The regulatory professional’s roles and responsibilities often begin in the research and development phases, moving into clinical trials and extending through premarket approvals, manufacturing, labeling and advertising, and post-market surveillance. With the completion of this master's, you will be able to get all the required knowledge not only the local regulation but also globally with “ hands-on “ cases and experiences.
Modality
On-line
Duration
24 Months
Why regulatory affairs is an attractive career choice
Regulatory affairs (RA) practitioners are in charge of making sure that new medications and healthcare products are developed and commercialized per all applicable international rules and regulations. Given that it works with local and international stakeholders in healthcare to assure compliance and safety of pharmaceutical products, it is a young, multifaceted profession with a worldwide scope.
For people who prefer non-clinical environments and wish to combine their technical, business, and managerial talents, this is an intriguing career option in healthcare.
Regulatory Affairs Fundamentals and Organization Structure
- Overview of drug and development history
- Drug discovery and research. Recent innovations and contributions
- Overview of key drug formulations, delivery systems, and administration routes
- Product life cycle (food supplement, medical device, cosmetics, vet, herbs, drug, biologicals )
- Regulatory dossier structure
- Interdependencies of other departments (BE, analytical, stability, etc )
- Organizational culture in the pharmaceutical industry
- Interaction with cross-functional teams and global teams
- Communication frames and company core values
- What you need to know before joining an organization
Market Surveillance & Pharmacovigilance
- Introduction to the Pharmacovigilance
- Functions of the Pharmacovigilance department
- Terminology
- Department links in the company to pharmacovigilance
- Basic concept Legislation
- Good Pharmacovigilance practices
- Health authorities involved: European Medicines Agency (EMA), AEMPS, and other official bodies
Pathophysiology and Pharmacology
- Etiology and pathogenesis are used to predict clinical manifestations and response to therapy
- Normal and abnormal physiologic parameters defined
- General factors affect the expression of disease in a particular person
- Kinds of information about the disease can be gained through understanding concepts of epidemiology
- Introduction: The nature of drugs, drug development & regulation
- Drug Receptors & Pharmacodynamics
- Pharmacokinetics & pharmacodynamics: Rational dosing & the time course of drug action
- Drug biotransformation
- Pharmacogenomics
- Toxicology
Non-Clinical vs Clinical Data
- Intro to non-clinical/clinical
- Summary of product characteristics
- Overview of the quality modules 1,2,3,4& 5
- Key regulations for conducting bioequivalence studies in the MENA region
- Accredited Bio-equivalence centers and HA inspections
Pharmaceuticals in MENA Region I ( Egypt & Lebanon , Syria , Iraq , Jordan )
- Regulatory authorities in MENA and structure (Egypt, Levant)
- Module 1 in different countries
- Different classifications and types of registration
- Regulations of MAA submission across Egypt and the Levant for a pharmaceutical product
- Regulations of Life cycle maintenance activities ( renewals )
Variation in MENA Region I (Egypt & Lebanon , Syria , Iraq , Jordan )
- Regulations of Life cycle maintenance activities
- Types of variations
- Supply, importation, and grace periods
Quality Module and Compliance
- Overview of ICH guidelines
- Overview of Drug Master file and API
- Accepted analytical testing and procedure in MENA I, and II region
- Accepted stability testing and process validation in MENA I, and II region
- Interaction and communication with HA and contracted vendors
- Regulatory key SOPs and code of conduct
- Security, privacy, and data protection
- Deviations and CAPA
- Regulatory ethics
- Audit, Quality, and compliance
- The objective is to link key Knowledge in both analytical and microbiological science needed to develop and review quality module
Data Management & Registration Dossier
- Corporate and Data collection, regulatory systems (Veeva, RIM,…)
- RegIntel systems and HA e-portals
- Good achieving and documentation practice
- Recalls
- Track and trace regulations
- Preparation of electronic files: eCTD or NeeS
- Computer tools applied in the registration of medicines: RAEFAR II, CESP, CIMA, Labofar, IDMP, etc.
- Extended Medicinal Product Dictionary (XEVMPD): Eudravigilance
- Drug Master File (DMF)/CEP: Open, Closed Part, and Access Letter
- Labeling of medicines and telematic management of technical data sheets and leaflets
Pharmaceuticals in MENA Region II ( Gulf , Northafrica )
- Regulatory authorities in MENA and structure (Gulf, North Africa)
- Module 1 in different countries
- Different classifications and types of registration
- Regulations of MAA submission across the Gulf, North Africa for a pharmaceutical product
- Regulations of Life cycle maintenance activities
- Orphan medicine
- Interacting authorities (UPA, Tender)
Variation and Labelling in MENA Region II ( Gulf , Northafrica )
- Regulations of Life cycle maintenance activities
- Types of variations
- Supply, importation, and grace periods
- Overview of labeling
- Safety data and patient information: Core safety data sheet, PIL, SmPC
- E-labeling
- Country regulations and shared SKUs and interaction with supply
- Labeling variations and Dr. letters
Global Regulatory
- Machine learning, Big data, and Artificial intelligence in regulatory affairs
- Introduction to global regulatory agencies
- Overview of EMA, FDA, MHRA, Swiss medic, and Types of procedures
- Integrated markets, Mutual recognition agreements, Harmonization, ICH, WHO roles, and Global Supply
Medical Writing and Labelling
- Importance of Medical Writing from a Regulatory Perspective
- Crafting an Effective Message
- Basic Statistics
- Improving Document Quality
- Investigational New Drug Application (IND)
- Investigational Device Exemptions (IDE)
- Canadian Clinical Trial Application
- Investigational Testing Authorization (ITA)
- Investigational Medicinal Product Dossier (IMPD)
- European Clinical Trial Application
- Premarket Approval (PMA)
- 510(k) Premarket Notification
- Common Technical Document (CTD)
- New Drugs Application (NDA)
- Biological License Application (BLA)
- Marketing Authorisation Application (MAA)
Clinical Trials Applications
- Background to the history of clinical trial legislation
- Pharmaceutical clinical trial legislation – EudraLex 10
- ICH and its importance
- Key FDA requirements that differ from EU requirements
- Update one year after the Go Live implementation of the new Clinical Trials Regulation and implementation texts
- Clinical Trial Transparency
- The key changes in the Clinical Trials Regulation
- The new Clinical Trials Information System (CTIS) experience
- EU clinical trial application (CTA) for submission in the EU
- Notices and requests for information requirements
- Substantial changes/modification and non-substantial changes
- Ongoing and end-of-study reports including the layperson summary
- US regulatory requirements for clinical trials – US IND
- EC applications as part of the Clinical Trials National Approval
- Informed consent requirements
- Ethical considerations for running trials including countries outside of traditional
Global Medical Device Regulations
- An Introduction to the Medical Device Regulation
- Europe and the MDR Overview of the regulations applicable for bringing a medical device to market
- Economic operators and other parties
- Classification of devices
- Conformity assessment procedures
- Workshop: Classification
- Manufacturers’ responsibilities
- Quality systems
- Labeling of devices
- Post-Market Surveillance
- Regulation of the Middle East
- Combined devices
- Workshop: Labelling
- Clinical evaluations
Self-Medicated and Wellness Products
- Understanding Food and consumer care
- Deep dive into the classification
- Regulations of MAA submission across Egypt, the Levant, and the Gulf for food and consumer health
- Regulations of Life cycle maintenance activities
- Supply, importation, and grace periods
- Module 1 specifications
- R&D of cosmetic formulations for placement in the EU market
- Good Manufacturing Practices (GMP)
- Product Information File (PIF): Structure and contents
- Safety Assessment Report: structure, contents, and responsibilities of the EU Safety Assessor
- Labeling Requirements
- Advertising, Proof of Claims, and Alleged Effects
- Cosmetic Product Notification Portal (CPNP)
- Post-Market Surveillance – Cosmetovigilance obligations
Biologicals / Bio-Similars
- Understanding Biologics
- CMC Regulatory Guidelines for Biological Drug Products - Part 1
- CMC Regulatory Guidelines for Biological Drug Products - Part 2
- Understanding the Key CMC Aspects of the Common Technical Document (CTD) - Part 1
- Understanding the Key CMC Aspects of the CTD - Part 2 (continued)
- CMC Regulatory Requirements During Different Stages of Development - Part 1
- CMC Regulatory Requirements During Different Stages of Development - Part 2
- CMC Regulatory Requirements During Different Stages of Development - Part 3
- Building the Pharmaceutical Sections of the Dossier
- Understanding Source Documents
- Change Control for Biological Products
Here are the top five reasons why this young profession of RA has become an attractive career choice.
1. Potential for development and advancement
Opportunities for career growth in RA have been achieved as a result of the expanding influence and increased need for RA experts. The US Bureau of Labour Statistics projects that the regulatory affairs sector will expand by an average of 8% each year until 2026. Salaries for associate and coordinator levels increased at an annual rate of 6%, reflecting the growing demand for RA professionals at these levels.
2. Lack of qualified talent in the industry
As demand for RA candidates increases, supply decreases—leading to a tightened market.
60% of US pharmaceutical industry employment, according to industry trade body Pharmaceutical Research and Manufacturers of America (PhRMA), may be empty by 2025 as a result of a skills and labor deficit. One of the numerous causes of such scarcity is the absence of efficient options for education and training.
3. Numerous career opportunities and flexibility
The professional path in this field offers a wide variety of freedom and possibilities in addition to a wide range of entry options. Government organizations including the Food and Drug Administration, hospitals, medical research organizations, universities, pharmaceutical, biomedical, or diagnostics corporations are just a few potential employment. To ensure the compliance and safety of pharmaceutical goods, all of these organizations involved in drug development require experts with strong legal and regulatory knowledge as well as interpersonal skills.
Additionally, within RA, you could decide to concentrate on a certain topic based on your interests, abilities, and talents. You could concentrate on clinical affairs, regulatory compliance, or quality assurance. Since RA is frequently a source of information on worldwide regulatory issues, you might also be involved in tracking and analyzing the regulatory and compliance environment on a global scale.
4. A variety of transferable abilities
The RA profession combines expertise from a variety of subspecialties, including business, law, regulation, and life science. Regulatory affairs is a desirable profession for both new and seasoned professionals due to the variety of its scope, its critical position in the developing biomedical and healthcare sector, and the possibility of career advancement. Senior RA specialists typically hold a variety of academic degrees in management, engineering, technical sciences, law, business, and/or life sciences. Strong communication, people management, and attention to detail are all transferable and applicable in RA, and they also bring a lot of value to your professional progression as an RA.
5. The capacity to have an impact
Professionals in RA are crucial in bringing vital medical supplies and life-saving medications. Regulatory affairs experts are an essential resource for evaluating the efficacy and safety of new drugs. This career is tough, exciting, and gratifying because of the opportunity to have a greater impact on the healthcare community and to make a difference.
There is never a better moment than the present to think about regulatory affairs. Your knowledge and abilities will be enhanced by our Master Certificate in Regulatory Affairs program, which will prepare you for this line of work.
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