US RAC: Day-14: Non-Clinical I

What Will You Learn?

• In this Regulatory Affairs Certification (RAC) Drugs Exam coaching, you will learn a comprehensive range of topics related to regulatory affairs in the pharmaceutical industry. Here are some key areas you can expect to cover:
• 1. Regulatory Frameworks: Gain an understanding of the regulatory landscape governing drug development, approval, and marketing, including laws, guidelines, and regulatory agencies such as the FDA, EMA, and other global regulatory bodies.
• 2. Drug Development Process: Learn about the stages of drug development, from preclinical studies to clinical trials, and understand the regulatory requirements and documentation needed at each stage.
• 3. Regulatory Submissions: Explore the types of regulatory submissions required for drug approval, such as Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Marketing Authorization Applications (MAAs), and learn how to prepare and submit these documents.
• 4. Good Manufacturing Practices (GMP): Understand the principles and requirements of GMP for pharmaceutical manufacturing, including quality control, facility inspections, and documentation practices to ensure the safety, efficacy, and quality of drugs.
• 5. Clinical Trials Regulations: Explore the regulations governing clinical trials, including protocol design, patient recruitment, data collection, and reporting requirements, with an emphasis on ethical considerations and patient safety.
• 6. Post-Market Surveillance: Learn about pharmacovigilance and post-market surveillance activities, including adverse event reporting, risk management, and label updates, to monitor and ensure the safety of marketed drugs.
• 7. International Harmonization: Understand efforts to harmonize regulatory requirements across different regions and countries, such as the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and the implications for global drug development and registration.
• 8. Case Studies and Practical Exercises: Apply regulatory principles to real-world scenarios through case studies and practical exercises, honing your problem-solving skills and preparing you for the challenges of regulatory affairs in the pharmaceutical industry.
• Overall, the course aims to provide you with a comprehensive understanding of regulatory requirements, processes, and best practices specific to the pharmaceutical industry, equipping you with the knowledge and skills needed to pursue a career in regulatory affairs and succeed in obtaining RAC certification.