By Amos Ndhere MD, MS
5
11 ratings
The podcast currently has 18 episodes available.
Mpox Virus has evolved into two distinct clades I and II, each with differing transmission rates and virulence. These clades raises new concerns about transmissibility and what it means for the future of Mpox control and vaccine efficacy. This episode highlights evolutionary dynamics of Mpox Virus clades and their implications for public health!
References:
Outsourcing offers potential relief for pharmaceutical and biotechnology firms engaged in clinical trials. However, determining the most appropriate outsourcing approach presents challenges, consumes time, and carries inherent risks that could result in project failure.
Reevaluating one's strategy is imperative to ensure alignment with organizational goals and capacities. Furthermore, the selection of the optimal operational delivery model plays a pivotal role in achieving success.
This episode discusses the merits and demerits of each approach and aids pharmaceutical industry leaders in making informed decisions tailored to the needs of biotechnology or pharmaceutical enterprises.
✅ In-House Management
✅ Full Outsourcing
✅ Hybrid Model
Thanks for watching and see you at the next one. 👉 Subscribe for more expert guidance on clinical research like this one!
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Hi, I'm Dr. Amos Ndhere! I am a medical researcher and vaccinologist, and Regulatory affairs specialist.
My goal is simple: Help pharmaceutical industry leaders with the right tools, tips, and framework to deliver life-changing treatments to patients faster through clinical research and emerging market access.
Do you have a need for conducting clinical trials? Let's talk: https://www.aceresearchafrica.com/
The pharmaceutical industry suffers significant financial losses and delays market entry due to the overwhelming maze of clinical research regulatory requirements.
Here is a 3-step roadmap to perfect the timing of regulatory submission for success:
STEP 1. Identify Regulatory Authority.
STEP 2: Collect Regulatory Intelligence.
STEP 3: Strategize Submission.
Timing is everything! Submitting your regulatory documents on the most opportune dates can increase approval odds with aligned regulatory schedules.
Clinical trials play a crucial role in developing new medical treatments and vaccines for public health. 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 episode, I will explain the consequences and impact of clinical research regulatory delays.
DOWNLOAD FREE Regulatory Case Study to learn how to navigate the process efficiently.
https://aceresearchafrica-3272060.hs-sites.com/regulatorycasestudy
Clinical Trials in Africa: Opportunities & Benefits for Pharmaceutical Industry - PART 2 VIDEO
In this two-part episode series, I will examine the trends, drivers, and opportunity windows that shape the African clinical industry market dynamics and why industry sponsors should consider Africa in their product development plan and strategy.
Download a FREE report using this link. https://lnkd.in/ecaMvj-V
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 episode, 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
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Hi, I am Dr. Amos Ndhere, a medical doctor, vaccinologist and pharmaceutical product development specialist.I support pharma industry leaders to execute safe, cost-effective clinical trials that accelerate delivery of life-changing treatments to patients and grow emerging market share 📈.
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Hey there! Are you interested in discussing efficient and safe ways to deliver your next global health research? Let's have a chat and explore your options!https://www.aceresearchafrica.com/contact
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PS - Join the conversation on social
https://www.linkedin.com/in/amosndherehttps://twitter.com/amosndherehttps://facebook.com/amosndherehttps://www.instagram.com/amos.ndhere/Clinical Research #clinicalresearch #clinicaltrials #Africa #publichealth #gcp
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 episode, 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, 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 a reasonable cost, while adhering to safety concerns.
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Do you want to deliver your clinical trial in Africa safely?
Let's talk: www.aceresearchafrica.com
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PS - Join the conversation on social!
LinkedIn
Twitter
YouTube
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 episode, I will explain 7 simple strategies pharmaceutical sponsor teams can take to achieve their timeline objective and overcome regulatory obstacles.Listen now!
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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 reasonable costs while adhering to safety standards.
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Get Your FREE Regulatory FAQ To Build A Robust Regulatory Strategy:
Download Now
*****
PS - Join the conversation on social!
YouTube
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:
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 reasonable costs while adhering to safety standards.
*******
Do you want to deliver your next clinical trial in Africa safely?
Let's talk
******
PS - Join the conversation on social!
LinkedIn
Twitter
YouTube
The R&D window during an outbreak is very short; in some cases, there is only a limited number of patients for experimental treatment.
Pharmaceutical sponsors will struggle to complete the R&D of vaccines and treatments against global health biothreats in outbreak settings until they leverage lessons learned and decisive actions to overcome practical difficulties of R&D in an outbreak setting.
In this part-2 episode, I’ll explain additional key factors that led to R&D successes during the 2014-15 Ebola virus outbreak in West Africa. If you haven’t watched the part-1 video, I’ve included the link in the description below.
Watch PART 1 Video Now
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Hi, I'm Dr. Amos Ndhere! I am a medical doctor, Clinical Investigator, and Regulatory Affairs Specialist.
My goal is simple: Help Pharma industry leaders understand key trends, top strategies, and tools to conduct R&D in emerging markets and deliver life-changing treatments to patients faster.
*******
Do you want to deliver your clinical trial in sub-Saharan Africa safely?
Let's talk
*******
PS - Join the conversation on social!
LinkedIn
Twitter
YouTube
The podcast currently has 18 episodes available.