Regulatory Webinars
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Issue 2: Revolutionizing Traditional Medicine With Cannabis-Based Medicinal Products
2/1/2023
When a sponsor wanted to conduct a first-in-human test on a cannabis extract being studied for use in breakthrough cancer pain, discover the collaboration on the ideal development plan.
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Issue 1: Studying The Effects Of Drugs On Driving
2/1/2023
With more than 6,800 FDA-approved drugs, it is crucial to put in place a systematic effort to identify the drugs that increase the risk of motor vehicle accidents.
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The 505(b)(2) Pathway: Getting To The Clinic Faster
2/1/2023
Discover the advantages of the 505(b)(2) pathway, look at common misconceptions, and offer practical advice on its application in the real world.
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Evaluating Abuse Potential Of CNS-Active Drugs For EU And US Submissions
1/30/2023
Delve into the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.
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Considerations For Developing Rare Disease Treatments
1/17/2023
When developing a new therapy for a rare disease, learn why a thoughtful, strategic approach early in the development process supports a well-designed study and agreement to your approach from regulatory authorities.
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Managing The Medical Device Pre-Submission Process With The FDA
1/17/2023
Mohammad Asad offers valuable insights and strategies gleaned from his expertise, illuminating effective approaches to navigate this critical regulatory pathway.
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Accelerating Clinical Development In The Asia-Pacific Region
1/13/2023
Learn from industry experts on the market insights and tips for your successful clinical development in Japan and China.
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Tips To Ensure Market Entry Success In Japan: Challenges, Regulatory Updates And Success Factors
1/12/2023
Focus on an overview of the Japanese pharmaceutical market, its unique characteristics, regulatory updates and market entry options.
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Critical Insights For Oncology Drug Development In Japan And Asia
1/11/2023
Focus on tips and insights for early phase oncology drug development in Asia: the market trend, development strategy, regulatory requirements and a case study with step-by-step planning to ensure clinical trial success.
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Regenerative Medicine Development In Japan: Challenges And Key Success Factors For Rapid Approval
1/11/2023
The global regenerative medicine market anticipates to expand remarkably due to advancement in technology. Listen as experts share current challenges and provide key factors for success.