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ATMPs Hurdles & Achievements in Quality and Safety Part of PharmaCongress 2024 19/20 March 2024 Wiesbaden, Germany Highlights Quality and Regulatory Strategies New Isolator Technology Viral Vectors

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Researchers and developers in the field of advanced therapy medicinal products (ATMPs) who are required to comply with regulations and submit documentation related to atmps hurdles.

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What is atmps hurdles?

ATMPs hurdles refer to the regulatory requirements and assessments that Advanced Therapy Medicinal Products (ATMPs) must meet to ensure their safety, efficacy, and quality before they can be authorized for use.

Who is required to file atmps hurdles?

Manufacturers or developers of Advanced Therapy Medicinal Products (ATMPs) are required to file ATMPs hurdles as part of the regulatory submission process.

How to fill out atmps hurdles?

To fill out ATMPs hurdles, applicants need to gather necessary data on the product, including its design, manufacturing process, quality control measures, and clinical trial results, and submit this information according to the specific guidelines provided by regulatory authorities.

What is the purpose of atmps hurdles?

The purpose of ATMPs hurdles is to ensure that novel therapies meet stringent safety and quality standards before they can be approved for patient use, thus protecting public health.

What information must be reported on atmps hurdles?

The information that must be reported includes product characterization, preclinical and clinical data, manufacturing processes, quality control measures, and any relevant risk assessments.

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