The Pharmaceutical Marketing Authorization Holder (MAH) system is clearly proposed in the new Law People’s Public Drugs, which makes a series of policies changes in the drug administration mode.

Do you have the following questions about the reform?

• What are the duties and activities of the MAH in a pharmaceutical company?
• How do you structure the MAH system?
• How do you construct the commissioned production management for drugs?

If you have any above questions, check them out live with gempex experts on Tuesday, September 27!

1.     The Invitation

The lecture is organized by Feitian Education and trained by gempex GMP experts.

①The lecture name
Construction of MAH system and contract manufacture of drugs in line with the new regulations

②The lecture date
08:40-16:40 September 27, 2022 (6 hours)
③The lecturer
gempex GMP experts: Mr. Zhong & Mr. Fretcher Situ

④The lecture register

Scan the QR code and register！（Only in Chinese）

2.     The Brief of Lecture

①Analyze the holder responsibilities, activities and supervision points from the perspective of MAH

②Explain the basic concept and requirements of MAH system

③How to build the MAH system

④How to contract manufacture the drugs

3.     The Introduction of Lecturer

• GMP expert Mr. Zhong

1. International auditor and licensed pharmacist, with more than 10 years of pharmaceutical and GMP consulting experience.
2. Rich professional knowledge of GMP quality management, good at quality audit, quality system, MAH and other activities.
3. Participated in more than ten large-scale projects of quality system construction, maintenance and MAH activities. Managed gempex worldwide audit projects, serving customers and markets in China, Europe, the United States, Japan, Korea, etc.

• GMP expert Mr. Situ

1. Licensed pharmacist, with 17 years in pharmaceutical and consulting industry, and more than 10 years in GMP pharmaceutical consulting.
2. Good at GMP compliance planning, quality system construction, drug and medical device production license application and other activities.
3. Participated in the construction of GMP quality system in the pharmaceutical industry, GMP compliance inspection, GMP compliance audit, drug and medical device production license application, regulatory compliance training and other projects