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APAC. CIS. LATAM. You Aim To Work Everywhere. Here's how you do.

Secure the knowledge, connections and regulatory know-how to succeed in global markets.

From China to Brazil...we have you covered...

  • Get the latest information about regulatory harmonisation in the ASEAN region with PRO.MED.CS Praha a.s. 
  • Hear the very latest from  Biotest Pharma GmbH  on regulatory reform and the drug approval process in China
  • Get clarity on GMP inspections for foreign manufacturing sites by NMPA China with an in-depth case study   by SEPTODONT
  • Need practical advice and the latest requirements in Japan? Hear all about Japanese Regulation with GSK

  • Consolidate your knowledge of this huge market with regulatory and industry feedback
  •  Get the latest on the COFEPRIS transformation with  AbbVie Farmacéuticos
  • Everything you need to know when trying to register biosimilars with  Sandoz Biopharmaceuticals

  • Gain a comprehensive overview of the latest regulatory requirements in Russia with practical examples of API registration in RF and EAEU
  •  Looking for clarity on GMP inspections in Russia? 'Ivan Guliaev, Head of the Training and Development Department, Inspectorate of FSI answers your questions
  • From GMP inspections to serialization requirements: Navigate the challenges in CIS

Global Markets: What's on?

Trace and traceability in China – the past, the present and the future
  • Chinese requirement on serialization and aggregation
  • Traceability systems (government, manufacturer, distributors and consumers)
  • Difference between EU requirement and Chinese requirement
  • Impact on the industry

Ching Li, Manager, Corporate Regulatory Affairs, Biotest Pharma GmbH

Regulatory requirements for registrations: evaluation of efficacy, safety and quality

Understanding ANVISA pathways for product registration 

Patrícia Kott Tomazett, Health Regulatory Specialist, General Management of Drugs, Brazilian Health Surveillance Agency (ANVISA) 

Preparing for Russian GMP inspections
  • Requirements for documentation complete and sequence of actions of applicants for organization and supporting of Russian GMP Inspections
  • Data analysis based on the results of Russian GMP inspections. Exchange of experience: frequently encountered deviations, questions and possible solutions
  • How do Russian GMP inspections compare to EMA inspections? Harmonization of Russian regulatory system with international requirements

Ivan Guiliaev, Head of the Training and Development Department, Russian Ministry of Health

Assessing regulatory harmonisation in the ASEAN region
  • Examining the variation regulation in the ASEAN region: Understanding different countries interpretations of the guideline
  • Upcoming changes in the region
  • Advice for industry

Anna Hanzlikova, Head of Global Regulatory Affairs, PRO.MED.CS Praha a.s.

Conference Workshop: Filing Variations

Join our full day Filing Variations workshop on 23rd of April, with Sumaiya Patel, a director of a regulatory consultancy with over 11 years’ experience in both pre and post approvals for generic, CRO and big pharma organisations.

Run by Pharmaceutical Training International, our official training partner, this workshop will provide you with the knowledge necessary to ensure speedy regulatory approval and filing variation procedures that are cost-effective.