Building a Successful DMF Application Strategy for API, Excipient, and Packaging Material Registration in China

  • 2° EDIZIONE: 11 Marzo 2024
  • Online
  • Inglese

Contenuto del corso

For manufacturers looking to expand their market reach, China is an attractive destination thanks to its large and rapidly growing pharmaceutical industry. However, navigating the regulatory landscape can be a major challenge, particularly when it comes to DMF registration for API, excipient, and packaging materials. With strict requirements and timelines to adhere to, many manufacturers struggle to successfully register their DMFs in China. As a result, they miss out on opportunities to enter this lucrative market.

The purpose of this course is to provide manufacturers with the knowledge and strategies they need to successfully navigate the DMF registration process for API, excipient, and packaging materials in China. By attending this course, you will gain insights into the Chinese regulatory landscape, learn best practices for DMF registration, and gain practical knowledge from real-world case studies. Ultimately, the goal is to help you increase your chances of success when registering your DMFs in China, so you can take advantage of the opportunities presented by this dynamic and growing market.

Don’t miss this great opportunity to ask questions and seek guidance on DMF registration in China from industry experts, take advantage of the opportunity to ask questions during the Q&A session, clarify any doubts and discuss common questions regarding the DMF registration process in China, learn about resources available to manufacturers seeking guidance on DMF registration in China.

Overall, the goal of this course is to provide attendees with a comprehensive understanding of the DMF registration process for API, excipient, and packaging materials in China, and to equip them with the practical knowledge and strategies they need to successfully navigate this complex regulatory landscape.

Cosa saprai fare dopo il corso?

  • Have an overview of China regulatory landscape and the latest regulatory developments
  • Understand the process and key requirements for DMF registration of API, excipient, and packaging materials in China, and how they differ from other regulatory filings.
  • Identify common challenges and pitfalls that manufacturers may encounter during the DMF registration process in China, and learn strategies for overcoming them.
  • Learn best practices for DMF application submission in China, including key documents required, timelines, and communication with regulatory agencies.
  • Discover how to prepare for and handle technical reviews of DMF applications in China, including common review criteria and how to address deficiencies or questions.
  • Gain insights from real-world case studies of successful DMF registration for API, excipient, and packaging materials in China.
  • Learn about the latest trends and developments in DMF registration for API, excipient, and packaging materials in China, and how they may impact future regulatory requirements.
Struttura del corso

09:30– 12:30 SESSIONE CORSO

Programma

China Regulatory Framework
• Overview of the regulatory framework in China for API, excipient, and packaging materials (AEP) registration
• Key regulatory bodies and their roles in the AEP registration process
• Recent updates to China’s regulatory landscape

AEP Registration Pathways & Strategies in China
• Different pathways for AEP registration in China
• Best practices for AEP registration in China
• Strategies to streamline the AEP registration process

Procedures and Timelines
• Overview of the procedures and timelines for AEP registration in China
• Key milestones and timelines to keep in mind during the AEP registration process
• Tips for ensuring timely AEP registration in China

DMF Dossier Requirements & Checklist
• Key requirements for DMF dossiers in China
• Checklist for preparing a DMF dossier for AEP registration in China
• Common pitfalls to avoid during the DMF dossier preparation process

AEP Registration Costs
• Overview of the costs associated with AEP registration in China
• Factors that impact AEP registration costs
• Strategies for managing AEP registration costs

Comparison of China DMF with EU & U.S
• Comparison of the DMF registration process in China with that of the EU and U.S.
• Key similarities and differences between the different regulatory frameworks
• Implications for manufacturers seeking AEP registration in China

Pitfalls & Tips for Technical Requirements
• Common technical pitfalls in the AEP registration process in China
• Tips for ensuring compliance with technical requirements during AEP registration
• Strategies for addressing technical challenges during AEP registration

Conclusion
• Recap of key takeaways from the webinar
• Final thoughts and recommendations for attendees

Q&A
• Opportunity for attendees to engage with our panel of experts and get your questions answered in real-time
• Information about resources available to attendees seeking guidance on AEP registration in China

This course is designed for professionals who are involved in the pharmaceutical industry and need to understand the regulations on how to register AEPs successfully in China. For professionals includes:

  • Regulatory Affairs
  • Quality Assurance/Control
  • Regulatory Compliance
  • Project Management Professionals
  • Business Planning 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

Raymond Ng

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

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.

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550€

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