Building a Successful DMF Application Strategy for API, Excipient, and Packaging Material Registration in China
- 27 November 2024
- Online
-
English
- 27 November 2024
- Online
-
-
English
-
Training overview
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.
Interested in Regulatory Affairs training?
Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:
- CTD Modulo 3: I Punti Critici
- La Scrittura Efficace dei Documenti Tecnici
- Aspetti Regolatori degli Integratori Alimentari e Novel Food
- Focus sul Modulo 5 del CTD
- Requisiti Registrativi per gli APIs in area extra EU
- La Registrazione di un Farmaco: Linee-Guida di Tossicologia e Struttura CTD per la Sezione Preclinica
- Impatto Regolatorio dei Cambi
- Affari Regolatori: Le Basi dei Regulatory Affairs
- Building a Successful DMF Application Strategy for API, Excipient, and Packaging Material Registration in China – English training
- Marketing Authorization Holder (MAH), Affari Regolatori e Qualified Person: Responsabilità ed Interazioni per la Compliance GMP
- La Gestione delle Elemental Impurities
(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.
Key points of the training
- 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.
Course Structure
09:30– 12:30 SESSIONE CORSO
Program
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
The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.
For online trainings the access link will be sent 2-3 days before the start of the training.
5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.
Cancellation terms
In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.
Participant replacement
It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.
Training cancellation
If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.
Speakers
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.
Register now
580€
Training materials available for attendees
Certificate of attendance
Senior trainers with hands-on experience
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