GLOBAL REGULATORY AFFAIRS
The Global Regulatory Affairs Short Course Training offered by Aksumia Global Learning Solution (AGLS) is designed to provide professionals with the expertise needed to navigate both local and global regulatory frameworks effectively. This program equips participants with theoretical knowledge and practical skills in regulatory science, ensuring compliance with international standards such as WHO, FDA, EMA, ICH, AMA, and Kenyan regulations (Pharmacy and Poisons Board - PPB).
ICT Requirements
By the end of the training, participants will be able to:
Throughout the Global Regulatory Affairs Short Course Training, various assessment techniques will be employed to evaluate participants' understanding and proficiency:
Pre-Test: Evaluates baseline knowledge before training.
Continuous Assessment: Includes online quizzes, short exercises, and active participation in sessions.
Project Evaluation: Assessed based on presentation depth, creativity, and feasibility.
Case Studies: Practical application of real-world regulatory scenarios.
Self-Paced Learning Tests: Additional practice through LMS-based tests.
Post-Test: Comprehensive final evaluation to measure learning outcomes.
To qualify for a certificate of competence, candidates must achieve a minimum passing score of 80% on the post-test administered at the end of the training.
This course is designed for healthcare professionals and other individuals interested in regulatory affairs.
To obtain CPD or CME Credit, complete the post-tests with an 80% pass rate. Complete the evaluation survey online and submit. A certificate will be mailed within a week of course completion date to the email address provided at the time of registration.
This module introduces participants to the field of drug regulatory affairs, providing a comprehensive understanding of the roles and responsibilities of regulatory agencies.
By the end of this module, participants will be able to:
1. Understand the function and importance of regulatory agencies in pharmaceutical governance.
2. Learn about the drug registration submission process, timelines, and evaluation procedures at PPB.
3. Recognize key ethical principles in regulatory affairs, including GCP, GLP, GDP, and QSR.
This module explores international regulatory frameworks and global harmonization initiatives. Participants will examine how regulatory agencies such as WHO, ICH, EMA, FDA, and PPB align their policies to create standardized approaches to drug registration, manufacturing, and quality assurance. The module also covers the role of the African Medicines Agency (AMA) in improving regulatory convergence in Africa.
By the end of this module, participants will be able to:
1. Understand global regulatory frameworks and harmonization efforts.
2. Compare regulatory requirements among WHO, ICH, EMA, FDA, and PPB.
3. Explore the role of AMA in strengthening African regulatory capacity.
This module provides an in-depth understanding of the preparation, compilation, and submission of regulatory dossiers for drug approval. Participants will learn about the Common Technical Document (CTD) format, which standardizes dossier submissions globally, as well as the requirements set by PPB and other international regulatory authorities. The module also covers post-approval variations, amendments, and regulatory compliance measures.
By the end of this module, participants will be able to:
1. Understand the CTD format and its significance in regulatory submissions.
2. Learn the administrative and legal requirements for dossier preparation.
3. Explore the submission process, post-approval variations, and lifecycle management.
This module focuses on regulatory inspections, compliance with Good Manufacturing Practices (GMP), and quality assurance strategies in pharmaceutical manufacturing. It provides insights into risk-based approaches to GMP compliance, inspections conducted by PPB and other global regulators, and the handling of non-compliance, product recalls, and corrective actions.
By the end of this module, participants will be able to:
1. Understand the principles of GMP and its role in ensuring pharmaceutical product quality.
2. Learn about the risk-based approach to GMP compliance and regulatory inspections.
3. Develop strategies for handling regulatory non-compliance and product recalls.
This module provides an in-depth exploration of API and FPP, focusing on their role in pharmaceutical manufacturing, regulatory requirements, quality control, and stability. Participants will learn about the importance of maintaining strict compliance with pharmacopoeial standards and stability requirements to ensure drug safety and efficacy.
By the end of this module, participants will be able to:
1. Learn about API and FPP specifications, including identification, purity, and potency.
2. Understand pharmacopoeial compliance and regulatory expectations.
3. Examine excipients, packaging materials, and stability testing to ensure drug efficacy and shelf life.
This module covers clinical trials, bioequivalence studies, and pharmacovigilance to ensure the safety and efficacy of pharmaceuticals. Participants will gain an understanding of Good Clinical Practice (GCP), the role of bioequivalence in generic drug approval, and the importance of post-marketing safety monitoring in preventing adverse drug reactions.
By the end of this module, participants will be able to:
1. Understand the regulatory framework governing clinical trials and bioequivalence studies.
2. Learn about pharmacovigilance systems and risk management approaches.
3. Explore regulatory expectations for Adverse Drug Reaction (ADR) reporting.
This module focuses on the importance of post-marketing surveillance in ensuring continued drug safety and efficacy. It covers regulatory requirements for Periodic Safety Update Reports (PSUR), adverse event monitoring, and managing variations in drug registration post-approval. Participants will learn how regulators and industry professionals collaborate to identify, assess, and mitigate risks associated with marketed drugs.
By the end of this module, participants will be able to:
1. Understand the role and importance of post-marketing surveillance in public health.
2. Learn about PSUR, signal detection, and regulatory compliance in market surveillance.
3. Explore regulatory procedures for variations and how they impact the lifecycle of a drug.
This module provides an in-depth look into the regulatory pathways for biologics, biosimilars, and advanced therapies, such as gene and cell therapy products. Participants will learn about the unique challenges associated with biologics development, including comparability studies, safety assessments, and post-market surveillance.
By the end of this module, participants will be able to:
1. Understand the regulatory approval pathways for biologics and biosimilars across different regions.
2. Learn about comparability studies, nonclinical and clinical considerations in biosimilar development.
3. Explore post-approval monitoring strategies for biologics and biosimilars.
This module provides a comprehensive overview of the regulatory frameworks governing veterinary products, nutraceuticals, and herbal medicines. Participants will gain insight into the requirements for registering, marketing, and ensuring compliance for these products both in Kenya and internationally.
By the end of this module, participants will be able to:
1. Understand PPB registration requirements for veterinary products, herbal medicines, and nutraceuticals.
2. Learn about global regulatory frameworks, including WHO, FDA, and veterinary-specific guidelines.
3. Explore quality assurance, labeling requirements, and advertising regulations for both human and veterinary applications.
This module covers the regulatory landscape for medical devices, focusing on classification, quality assurance, and post-market surveillance. Participants will explore the requirements set forth by international regulatory agencies, including ISO 13485, and learn about risk management strategies necessary for maintaining compliance.
By the end of this module, participants will be able to:
1. Understand the classification and regulatory approval process for medical devices.
2. Learn about ISO 13485 and its role in medical device quality assurance.
3. Explore post-market surveillance requirements, including risk management and adverse event reporting.
This module provides participants with a comprehensive understanding of ethical considerations in regulatory affairs. It covers the principles of ethical decision-making, regulatory compliance expectations, and best practices in communication with regulatory bodies.
By the end of this module, participants will be able to:
1. Understand the ethical principles governing regulatory decision-making.
2. Learn best practices for handling regulatory inspections and ensuring compliance.
3. Develop skills to effectively communicate regulatory requirements and expectations.
This module equips participants with leadership skills essential for regulatory professionals. It covers strategies for effective leadership in regulatory affairs, managing change in regulatory environments, and handling crises in pharmaceutical and medical device regulation.
By the end of this module, participants will be able to:
1. Develop leadership and strategic decision-making skills in regulatory affairs.
2. Learn about change management strategies and their impact on regulatory environments.
3. Understand crisis handling and risk mitigation techniques in regulatory settings.
This module explores career opportunities in regulatory affairs and highlights emerging trends shaping the future of regulatory science. Participants will gain insights into the evolving regulatory landscape, including the role of artificial intelligence (AI), digital health, and big data analytics in regulatory decision-making.
By the end of this module, participants will be able to:
1. Identify various career pathways in regulatory affairs across different sectors.
2. Understand the impact of AI, digital health, and automation on regulatory science.
3. Develop strategies for professional growth and networking in the regulatory field.
