From Application to Approval: A Step-by-Step Guide to Pharmaceutical Registration in China

  • 2° EDIZIONE: 25 Marzo 2024
  • Online
  • Inglese

Contenuto del corso

Navigating the regulatory landscape for pharmaceutical registration in China is complex and challenging, with stringent requirements, procedures, and timelines to consider. To help pharmaceutical manufacturers maximize their chances of success and gain market access in China, this course provides valuable insights and guidance on the registration process.
The course covers the regulatory framework, procedures, timelines, and requirements, as well as registration pathways, strategies, and a checklist of dossier requirements for successful registration. Attendees will gain an in-depth understanding of the registration process and associated costs and challenges, enabling them to develop a comprehensive strategy for successfully registering their products in this lucrative market. The course also includes a comprehensive guide to regulatory compliance, covering key considerations for GMP, GCP, and pharmacovigilance in China, essential for avoiding regulatory pitfalls and potential market access issues.

Attendees will have understanding of China’s pharmaceutical registration process and be better equipped for successful market access in this growing market.

Cosa saprai fare dopo il corso?

  • Understand the regulatory framework for pharmaceutical registration in China and the key regulatory bodies involved
  • Gain a comprehensive overview of the different registration pathways and strategies available in China
  • Understand the procedures, timelines, and requirements involved in the pharmaceutical registration process in China
  • Learn about the documentation requirements for successful registration, including the dossier requirements and checklist
  • Gain insights into the costs associated with pharmaceutical registration in China and how to develop a comprehensive strategy for success
  • Understand the differences between the Chinese and Western regulatory frameworks, including the comparison with EU and US regulations
  • Learn about the potential pitfalls and challenges in the registration process and how to navigate them successfully
  • Gain knowledge about the key considerations for imported drugs registration in China to ensure regulatory compliance and market access
  • Have the opportunity to ask questions and get expert advice from experienced professionals in the field
Struttura del corso

09:30– 12:30 SESSIONE CORSO

Programma

China Pharmaceutical Regulatory Framework: Gain an understanding of the regulatory landscape in China and the latest regulatory developments.

    • Drug lifecycle management
    • Competent authorities
    • China medical insurance system

China Drug Registration Overview: Learn about the application types, drug classification, process, timelines and costs involved in the drug registration in China.

    • Basic concept
    • Classification
    • Registration process
    • Registration timeline
    • Registration cost

Imported Drug Registration: Gain insights into imported drug registration process, overseas data compatibility, data gap challenges and learn from the case study of industry experts

    • Registration process
    • Product analysis-overseas data acceptance
    • Data gap analysis-regulatory challenge
    • Case study

Post-marketing Surveillance: Learn about local requirements and the to-do-list after market approval in China and be ready in advance

    • pharmacovigilance (ADR Monitoring)
    • Traceability system
    • Product recall

Tips & Pitfalls: Learn about the common tips and pitfalls from practical experience for successful drug registration in China.

30 min Q&A: Engage with our panel of experts and get your questions answered in real-time.

This course is designed for professionals who are involved in the pharmaceutical industry. For professionals includes:

  • R&D Professionals
  • Regulatory Affairs
  • Quality Assurance/Control Professionals
  • Regulatory Compliance Professionals
  • Project Management Professionals
  • Government Regulators and Officials
  • Contract Research Organizations (CROs)
  • Distributors and Importers
  • Consultants and Legal Professionals
  • Business Development And Marketing Professionals
  • Commercial Management Professionals

Il corso si sviluppa attraverso lezioni frontali. Grazie ad una metodologia didattica interattiva con presentazione ed esempi pratici, i partecipanti potranno avere spunti da poter applicare nella loro realtà professionale.

Se il corso è online, il link di partecipazione verrà inviato 2-3 giorni prima dell’inizio del corso.

Sconto del 5% per le iscrizioni entro 1 mese dal corso, sconto del 10% per le iscrizioni entro 2 mesi dal corso. I prezzi sono da intendersi IVA esclusa. Le offerte non sono cumulabili. Per sconti su iscrizioni multiple rivolgersi a info@pharmaeducationcenter.it

Modalità di cancellazione

Si richiede di comunicare la disdetta all’evento formativo inviando un’e-mail a info@pharmaeducationcenter.it entro due settimane dalla data di inizio dello stesso. Trascorso tale termine, si procederà con l’addebito dell’intera quota.

Modalità di sostituzione partecipante

Si prevede la possibilità di cambiare il nome del partecipante all’evento formativo, senza alcun costo aggiuntivo, inviando un’e-mail a: info@pharmaeducationcenter.it. Si chiede di dare comunicazione entro una settimana dalla data di inizio dello stesso indicando il nome del primo iscritto e il nome del sostituto.

Condizioni di annullamento o rinvio

Pharma Education Center si riserva la facoltà di annullare o posticipare l’evento formativo nel caso in cui non si raggiunga un numero minimo di partecipanti. Pharma Education Center si impegna a restituire la quota d’iscrizione già versata senza ulteriori oneri o su richiesta dell’iscritto concedere un bonus spendibile per la partecipazione ad un altro evento formativo in programma nell’anno corrente.

Docenti

Marylene Zhan

Marylene Zhan

Senior RA & PV Manager at Accestra Consulting

• Ms. Marylene Zhan is a senior RA & PV manager at Accestra Consulting with extensive experience in pharmacovigilance and regulatory affairs.
• With a Master’s Degree from the Zhongnan University of Economics and Law. Marylene is a seasoned bilingual and bicultural consultant who specializes in China regulatory compliance and pharmacovigilance services (RA/PV).
• She has a wealth of knowledge on Chinese Pharmaceutical regulations and in-depth insight into dealing with Chinese market access requirements.
• Marylene has a rich experience in serving international pharma companies with market entry into China, providing support in the areas of data gap analysis, pre-IND & IND support, NDA/ANDA registration, post-marketing pharmacovigilance consulting, and more.

Helen Ye

Helen Ye

RA & PV Director at Accestra Consulting

• Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China.
• She is experienced in regulatory compliance of China market access & post-marketing maintenance of pharmaceutical products, providing insightful and customized solutions to international pharmaceutical companies and government institutions.
• She leads the registration team to plan, develop and implement compliance strategy for top pharma clients and with successful track record for obtaining market approval for drug products, APIs, Excipients, Packaging Materials, medical devices and others.
• Ms. Ye has strong communication network with Chinese authorities (e.g. NMPA, CDE, NIFDC) and industry in-field experts in China.

Iscriviti al corso

Early Bird 10%
Valido fino a 2 mesi dal corso
495€
550€
Early Bird 5%
Valido fino a 1 mese dal corso
520€
550€
Full price

550€

Materiale del corso consegnato al partecipante

Rilascio attestato di partecipazione a fine corso

Massima qualità per contenuti e docenti selezionati

Potrebbe interessarti anche...

Richiedi informazioni