Regulatory Landscape for Biopharma in Africa (Emerging Markets Focus) Training Course

Regulatory Landscape for Biopharma in Africa (Emerging Markets Focus) Training Course

Introduction

The African biopharmaceutical industry is undergoing a significant transformation, marked by rapid growth, technological advancements, and increasing investment. As emerging markets on the continent expand, understanding the complex and often fragmented regulatory landscape becomes critical for success. Regulatory Landscape for Biopharma in Africa (Emerging Markets Focus) Training Course is designed to equip professionals with the essential knowledge and strategic insights needed to navigate the dynamic regulatory environment across key African regions. We'll delve into the nuances of regulatory harmonization, local market access strategies, and the evolving role of agencies like the African Medicines Agency (AMA), providing a foundational and practical understanding of how to ensure compliance and accelerate drug registration and market entry.

This course focuses on practical, real-world applications, moving beyond theoretical knowledge to provide actionable skills. Participants will explore case studies on market authorization, good manufacturing practices (GMP), and clinical trial approvals in diverse African countries. By mastering these key areas, professionals can mitigate risks, streamline operations, and capitalize on the immense potential of Africa's burgeoning biopharma sector. Our curriculum is tailored to address the unique challenges and opportunities presented by biologics, vaccines, and other innovative medicines, ensuring participants are well-prepared to contribute to the growth and development of a self-reliant and resilient healthcare ecosystem in Africa.

Course Duration

10 days

Course Objectives

1. Gain an in-depth understanding of initiatives like the African Medicines Regulatory Harmonization (AMRH) and the role of the African Medicines Agency (AMA) in streamlining regulatory processes.
2. Develop expertise in preparing and submitting marketing authorization applications (MAA) for both small-molecule drugs and biologics in diverse African jurisdictions.
3. Learn to interpret and adhere to Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and other quality standards essential for local operations.
4. Understand the specific regulatory requirements for clinical trial approvals and execution in different African countries.
5. Explore the regulatory challenges related to supply chain security, import/export regulations, and combating substandard and falsified medicines (SFMs).
6. Learn the principles of pharmacovigilance and post-market surveillance to ensure product safety and efficacy after launch.
7. Gain insights into the roles and responsibilities of National Medicines Regulatory Authorities (NMRAs) and other critical players.
8. Develop a strategic approach for market access and commercialization by integrating regulatory intelligence with business objectives.
9. Explore the impact of digital transformation and e-regulatory systems on the future of biopharma regulation in Africa.
10. Understand the evolving intellectual property landscape and its implications for pharmaceutical innovation and investment.
11. Gain knowledge of health policy, drug pricing, and reimbursement policies that affect the commercial viability of biopharma products.
12. Analyze the unique regulatory frameworks of key regional economic communities (RECs) and their impact on cross-border trade.
13. Forecast and prepare for upcoming changes in the regulatory landscape, including the rise of biosimilars and advanced therapy medicinal products (ATMPs).

Target Audience

• Regulatory Affairs Professionals 
• Biopharma Company Executives and Market Access Managers 
• Clinical Research Associates and Managers.
• Quality Assurance (QA) and Quality Control (QC) specialists 
• Business Development 
• Government Officials and Regulators 
• Health and Legal Consultants 
• Academics and Researchers.

Course Modules

Module 1: Introduction to the African Biopharma Regulatory Landscape

• Overview of African Pharmaceutical Market Dynamics
• Regulatory Fragmentation vs. Harmonization
• The Role of NEPAD and the African Union (AU
• Emerging Regulatory Science
• Case Study: Analyzing the impact of the African Continental Free Trade Area (AfCFTA) on pharmaceutical trade and regulation.

Module 2: The African Medicines Agency (AMA) and Regulatory Harmonization

• AMA's Mandate and Structure.
• AMA's Relationship with NMRAs
• Joint Assessments and Reliance Pathways
• Benefits and Challenges of Regional Integration
• Case Study: A look at the progress of the East African Community (EAC) in regulatory harmonization.

Module 3: Pre-Clinical and Clinical Trial Regulations

• Pre-clinical Data Requirements.
• Investigational New Drug (IND) & Clinical Trial Application (CTA) Processes.
• Ethical Review Boards and Patient Consent.
• Good Clinical Practices (GCP) in Africa.
• Case Study: A comparative analysis of clinical trial approval processes in South Africa vs. Kenya.

Module 4: Marketing Authorization and Dossier Submission

• Common Technical Document (CTD) Requirements.
• Dossier Compilation and Submission Strategies.
• Regulatory Timelines and Fees.
• Navigating In-country Registration Hurdles
• Case Study: The successful marketing authorization of a new monoclonal antibody in Nigeria and Ghana.

Module 5: Good Manufacturing Practices (GMP) and Quality Assurance

• GMP Standards in Africa.
• Facility Audits and Inspections.
• Quality Management Systems (QMS).
• Handling Product Recalls and Deviations.
• Case Study: Resolving GMP deficiencies identified during an inspection of a manufacturing plant in Egypt.

Module 6: Biologics and Biosimilars Regulation

• Defining Biologics and Biosimilars.
• Regulatory Pathways for Biosimilars.
• Interchangeability and Naming Conventions.
• Quality Control and Characterization.
• Case Study: The approval of Africa's first locally manufactured biosimilar.

Module 7: Vaccines and Emergency Use Authorization (EUA)

• Specific Regulatory Requirements for Vaccines.
• Emergency Use Authorization (EUA) Frameworks.
• Cold Chain Management and Logistics.
• Role of Global Initiatives.
• Case Study: The regulatory challenges faced during the COVID-19 vaccine rollout in Africa.

Module 8: Post-Market Surveillance and Pharmacovigilance

• Defining Pharmacovigilance (PV.
• Adverse Event Reporting
• Risk Management Plans (RMPs) & Signal Detection.
• PV System Audits.
• Case Study: Managing and reporting an adverse event for a new anti-infective drug in South Africa.

Module 9: Supply Chain Regulations and Anti-Counterfeiting

• Import and Export Licenses.
• Serialization and Traceability.
• Combating Substandard and Falsified Medicines (SFMs)
• Logistics and Distribution Challenges
• Case Study: A successful public-private partnership to combat counterfeit medicines in a key West African market.

Module 10: Regulatory Intelligence and Strategy

• Sources of Regulatory Information.
• Building a Regulatory Intelligence Framework
• Strategic Planning for Market Entry.
• Lobbying and Stakeholder Engagement
• Case Study: Developing a regulatory strategy for a novel oncology drug targeting a specific African demographic.

Module 11: Intellectual Property (IP) Protection

• Patent and Trademark Registration.
• Compulsory Licensing and Parallel Imports.
• Data Exclusivity and IP Rights.
• IP Enforcement and Litigation.
• Case Study: Navigating a complex patent dispute over a generic drug in an African court.

Module 12: Drug Pricing and Reimbursement

• Drug Pricing Controls and Policies.
• Health Technology Assessment (HTA
• Reimbursement Pathways.
• Value-Based Pricing.
• Case Study: Negotiating a favorable price and reimbursement for a high-cost biologic in an African country.

Module 13: E-Regulatory Systems and Digital Transformation

• Online Submission Portals.
• Digitalization in Regulatory Affairs.
• Impact of Artificial Intelligence (AI) and Big Data
• Data Privacy and Security.
• Case Study: The rollout and adoption of a new digital submission platform by a major African NMRA.

Module 14: Regional Focus: A Deeper Dive into Key Markets

• Regulatory Environment in West Africa.
• Regulatory Environment in East Africa.
• Regulatory Environment in Southern Africa
• Regulatory Environment in North Africa.
• Case Study: Comparing the regulatory approval of a new medical device across three different African regions.

Module 15: Future Outlook and Strategic Action Planning

• Emerging Trends in African Biopharma.
• Investor Perspectives and Challenges.
• Developing a Strategic Roadmap
• Networking with Experts.
• Case Study: Preparing a five-year strategic plan for a biotech startup entering the African market.

Training Methodology

The course employs a highly interactive and practical training methodology, designed to ensure a deep and lasting understanding of the subject matter.

• Interactive Lectures.
• Case Studies.
• Group Discussions and Workshops.
• Role-Playing Exercises: Simulating regulatory negotiations and dossier submissions.
• Guest Speakers.

Register as a group from 3 participants for a Discount

Send us an email: info@datastatresearch.org or call +254724527104 

Certification

Upon successful completion of this training, participants will be issued with a globally- recognized certificate.

Tailor-Made Course

 We also offer tailor-made courses based on your needs.

Key Notes

a. The participant must be conversant with English.

b. Upon completion of training the participant will be issued with an Authorized Training Certificate

c. Course duration is flexible and the contents can be modified to fit any number of days.

d. The course fee includes facilitation training materials, 2 coffee breaks, buffet lunch and A Certificate upon successful completion of Training.

e. One-year post-training support Consultation and Coaching provided after the course.

f. Payment should be done at least a week before commence of the training, to DATASTAT CONSULTANCY LTD account, as indicated in the invoice so as to enable us prepare better for you.