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Detailed Program

Accelerate Your Approvals: Video-Based Regulatory Affairs Expertise from assessors prospective

About

Introducing an essential online video-based program for pharmaceutical professionals focusing on mastering regulatory submissions for drug and biologics approvals. The program includes: Video 1: Mastering Applications-An assessor prospective Explore assessors' insights on achieving regulatory submissions, emphasizing the criteria for quality, safety, and efficacy. Learn best practices for crafting compliant CMC submission documents to enhance approval likelihood. Video 2: Common Marketing Authorization Deficiencies-An assessor prospective Delve into Chemical Manufacturing and Controls (CMC) documentation, identifying and rectifying common deficiencies that complicate submissions. Gain strategies to streamline processes, utilize ICH guidelines, and avoid typical errors. Benefits: Gain strategic insights and practical guidance. Learn error avoidance to enhance approval rates. Optimize resource efficiency and professional development. Audience: Ideal for regulatory affairs professionals, quality assurance teams, CMC specialists, and pharmaceutical consultants looking to refine their understanding and approach to regulatory submissions. This program arms professionals with knowledge and strategies to navigate approval complexities effectively, ensuring compliance and success in the competitive pharmaceutical market. Transform your regulatory approach with expert insights.

You can also join this program via the mobile app. Go to the app

Overview

Price

Single Payment
€199.00
Exclusive Bundle Pack-Program and eBook
€149.90

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We are located near Basel

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Apsyos

As Health is the main priority in our lives, it is important that patients get the most appropriate and safe treatments in the fastest and most reliable way without compromising of its quality.

About

​Apsyos offers small and medium pharmaceutical and biologic manufacturers the freedom to focus their internal capacities towards Science and Clinical Concerns by alleviating technical regulatory aspects.

We are operating from London and Basel

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J2 RA CMC Services Ltd, 128 City Road EC1V 2NX, London, United Kingdom

Registered Company Nr: 16260386

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