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

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

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

Programma

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.

A chi si rivolge

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

Metodologia

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.

Pagamento

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

Raymond Ng

Senior Regulatory Affairs Manager at Accestra Consulting

• Mr. Ng is based in China with almost a decade of regulatory affairs experience for Chinese market with a Master’s Degree from the University of Nottingham
• He has extensive knowledge of Chinese pharmaceutical regulatory requirements and has worked on numerous regulatory submissions with Chinese health authorities.
• Mr Ng has strong communication and practical experience dealing with the China NMPA (formerly CFDA) and CDE.
• A successful track record of supporting top 50 pharma companies as well as biotech and medtech with market entry into China.

April Wang

China Pharmaceutical Regulatory Affairs Manager at Accestra Consulting

Ms. April Wang is devoted to helping overseas pharmaceutical companies understand Chinese regulatory requirements.

She has in-depth understanding on Chinese Pharmaceutical Import & Export regulations and has accumulated extensive hands-on experience with drug registration projects during daily work, including Drug Registration, OTC registration, DMF filing.
She has strong communication network with Chinese authorities including NMPA and CDE.
Successful track record with supporting international pharma with market entry into China including well-known large enterprises and SMEs.

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€

Edizione del corso

Tipo di biglietto

Svuota

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