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

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.

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.