International Conference on Harmonization (ICH) Good Clinical Practice (E-6) requires investigators and sponsors to retain specific study records associated with the conduct of clinical research. These documents are often referred to as Essential Documents. ? In this video, I share insights about clinical research record retention in the context of global health trials. The practices, essentially follows International Conference on Harmonization-ICH GCP Guidelines E-6 section 8 ****** Hi, I am Dr. Amos Ndhere, a medical doctor, vaccinologist and pharmaceutical product development specialist. I ..read more

Clinical trials play a crucial role in developing new medical treatments and vaccines. They are the stepping stones that bring hope to patients. Regulatory delays have significant consequences for the pharmaceutical industry and patients and their families who rely on timely R&D of new treatments for better outcomes and quality of life. In this video, I will explain the consequences and impact of clinical research regulatory delays. Get a FREE Regulatory Case Study and Discover How You Can Accelerate Your Start-up in Africa Download Now ****** Hi, I'm Dr. Amos Ndhere! I am a medical doctor ..read more

As a pharmaceutical sponsor of clinical research, you want a seamless, efficient, and prompt regulatory submission, review, and approval for your next clinical trial. The challenge lies in the fact that the regulatory process may have its own pace. But what if you strategically aligned your team's objectives with the regulatory agency's course to accelerate clinical trial regulatory approval for your next vaccine or drug trial?   In this video, I will explain 7 simple strategies pharmaceutical sponsor teams can take to achieve their timeline objective and overcome regulatory obstacles. Li ..read more

This two-part episode reveals 12 common non-sponsor-related causes and reasons for clinical regulatory delays and offers expert insights and guidance on navigating them. Understanding these causes helps Sponsor teams to: Plan Regulatory Submission, Make informed GO/No-Go Decisions, Mitigate Risks, and Hedge Clinical Development Plan.  Listen now! ***** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist. My goal is simple: Reduce the pain of clinical research and help biopharma industry leaders get new treatments to market faster at ..read more

Conducting vaccine and drug clinical trials during disease outbreaks can be a drag. Sponsors will struggle to deliver new products against global health biothreats unless they leverage lessons learned during previous studies to influence clinical research development plans during future outbreaks. In this Episode #03, I will explain how lessons learned during the 2014-15 West Africa Ebola virus outbreak can supercharge R&D during future outbreaks and deliver life-saving clinical products to patients and families faster. ***** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investi ..read more

Regulatory authorities in Sub-Saharan Africa are scrutinizing pharmaceutical companies’ risk management and control practices with more rigor than ever before. Choosing the right insurance for human clinical trials can be difficult, especially in sub-Saharan Africa. Clinical trial sponsors must procure appropriate insurance coverage, which must fulfill country-specific statutory requirements and provide adequate risk management and control during the life of a clinical trial. In this episode, you will learn: - What is clinical trial insurance?  - Forms of insurance policies - Types of ins ..read more

Africa's pharmaceutical market is $60B, and CAGR is about 10%. Global pharmaceutical companies will struggle to break into the growing African market until they position pharmaceutical products correctly. In this video, I will explain how Medical Affairs can position products for the growing African market and WIN a piece of the $60B market share. ***** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist. My goal is simple: Help YOU with the right tools, tips, and framework to deliver life-changing treatments to patients faster through clin ..read more

This two-part episode reveals 12 common non-sponsor-related causes and reasons for clinical regulatory delays and offers expert insights and guidance on navigating them. Understanding these causes helps Sponsor teams to: Plan Regulatory Submission, Make informed GO/No-Go Decisions, Mitigate Risks, and Hedge Clinical Development Plan.  Listen now! ***** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist. My goal is simple: Reduce the pain of clinical research and help biopharma industry leaders get new treatments to market faster at ..read more

As a pharmaceutical sponsor of clinical research, you want a seamless, efficient, and prompt regulatory submission, review, and approval for your next clinical trial. The challenge lies in the fact that the regulatory process may have its own pace. But what if you strategically aligned your team's objectives with the regulatory agency's course to accelerate clinical trial regulatory approval for your next vaccine or drug trial?   In this video, I will explain 7 simple strategies pharmaceutical sponsor teams can take to achieve their timeline objective and overcome regulatory obstacles. Li ..read more

This two-part video reveals 12 common non-sponsor-related causes and reasons for clinical regulatory delays and offers expert insights and guidance on navigating them.Understanding these causes help Sponsor teams to Plan Clinical Trial Application (CTA), Make informed GO/No-Go regulatory decisions, Mitigate unforeseen hurdles, and Hedge their clinical development strategy.  Listen now! ****** Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory affairs specialist.My goal is simple: Reduce the pain of clinical research and help biopharma industry leaders ge ..read more