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

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

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.