As the sponsor of PDI'2019 Injection Industry Conference, Lenge Purification sincerely invites you to attend the conference and look forward to your visit!
Time: September 4-6, 2019
Venue: Shanghai Marriott Hongqiao Hotel
Lenge Purification booth number: No.29-30
On December 22, 2017, the Technical Requirements for Consistency Evaluation of Listed Chemical Generic Drugs (Injections) (Draft for Comment) was released, which opened the prelude to the consistency evaluation of injections; On March 13, 2018, the "Technical Guidance on Drug Injection Research and Development" (draft for comment) was released; Since 2019, the consistency evaluation of injections has accelerated, and CDE has released an intensive list of reference preparations. The list of reference preparations of the 21st batch of generic drugs contains 327 varieties, 224 varieties are injections, and the list of reference preparations of the 22nd batch of generic drugs contains 495 varieties, 231 varieties are injections.
With the advent of the post-4 +7 era, the generic drug industry has returned to the industry value of high quality and low price, and injections have entered a new era of integration with the quality and efficacy of Europe, America and Japan. How should the development strategy of pharmaceutical enterprises be adjusted in time to focus on innovative drugs, generic drugs, improved drugs, high-end injections? Or gradually adjust the R&D pipeline in exchange for time and space? How to choose existing projects for 4+7? How to obtain raw materials and package materials quickly to accelerate the consistency evaluation of injection? How to upgrade the key technologies of injection? How can a gigafactory be designed and built for optimal cost control? Aseptic drug manufacturers have encountered greater opportunities and challenges in the upgrading process than ever before.
This session of the conference will focus on the consistency evaluation of injections, focusing on the latest policies, regulations, technical standards, market dynamics and future trends of the industry in the research and development, manufacturing and circulation of sterile drugs, gathering global resources and discussing various solutions for the specific implementation of enterprises to promote industrial upgrading. Invited speakers come from domestic and foreign regulatory agencies, industry associations, scientific research institutions, large pharmaceutical manufacturers, investment institutions and consulting companies.
The organizers of the conference strive to build the most distinctive communication platform in the field of domestic injections, solve more practical problems for aseptic drug manufacturers, and provide more effective offline cooperation opportunities for upstream suppliers.
