Regulatory Dossier Management​

LATAM

Peru

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The Latin America (LATAM) markets are becoming increasingly important to worlwide pharmaceutical companies in their strategies for global registration of new medicines and making them available to patients. Therefore, it is important and challenging for health professionals, especially for those involved in the management of applications for new products, to know in detail the local health regulations and global trends on drug  registration process.

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In the abcense of a harmonized regional process for registration (Pharma & Biotech) in Latin America, local Regulators fall onto country-specific requirements and unique approval processes that might challenge the feasibility / supply / access of overseas drugs.​

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Global Regulatory Affairs® offers this training session leading by local experienced bilingual experts that will guide you on LATAM regulatory landscape and provides a solid understanding of the CMC information needed to support marketing applications, renewals and post approval submissions highlighting particularly such local milestones on each country.

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The Journey starts with a deep look at the regulatory framework of PERU

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​​​​​The program empowers you to increase your knowledge, decision making tools and your competitive advantage around LATAM drug product  registration

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Who is this training suitable for?

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.The programme ​is aimed at employees or any professional involved in regulatory affairs who are either new to operations in Latin America or are already working in the region and want to strengthen their knowledge in Latin America (LATAM) regulatory registration process & ladnscape.

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• Regulatory specialist 

• Regional coordinators

• CMC Writers

• Project Managers

• Auditors

• Consultants 

• Master students​​

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Programme content

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• Data protection  ( DS N.° 002-2009-SA)

• Peru's regulatory framework, current technical regulations and their modifications.(DS 016-2011 SA)

• Data protection  ( DS N.° 002-2009-SA)

• Regulatory process: From submissions to approvals

• Drug clasification

• Dossier content 

  • Legal documents​

  • CMC

  • Clinical information

  • Labeling

  • Country specific requiermets 

• Stability guideline

• Bioequivalence requirements ( DS N° 024-2018-SA )

  • Mandatory molecules​

  • Voluntary Bioequivalence submissions

  • Local forms

• Oncogoly & Rare desease registration pathway ( Law N° 31738)

• GMP guideline for overseas companies

  • Local forms​

  • Regulatory process : From submission to in-site Audit

• Renewal process

  • Requirements / Timelines / Fee​

• Post approval changes

  • Major variations​

  • Minor variations

  • Minor variations with inmediate implementation

  • Stock depletetion process.

• Approvals timeline & How to perform a regulatory intelligence in Perú

• Submissions process & fees

• Biotech regulation ( DS N° 011-2023-SA)

  • Dossier content for Biological products

    • Legal documents​

    • CMC

    • Clinical information

    • Labeling

    • Country specific requiermets 

• Biosimilar regulation 

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Tuition fee

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• $65.00 USD

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Payment 

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• Debit / Credit card

• Paypal​​​​

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