NEWS & EVENTS

Clinerion partners with PPC to bring Patient Network Explorer coverage and services to patients and hospitals in Korea, China and Taiwan.

August 30, 2019

ꟷ PPC will offer Patient Network Explorer services for accelerating clinical trial site selection and recruitment in Korea, China and Taiwan.
ꟷ PPC will support Clinerion in the expansion of their hospital network in Korea, China and Taiwan.
As part of the partnership, PPC will use the Patient Network Explorer platform to advance clinical trials, trial enrollment, and accelerate global studies conducted in the People’s Republic of China, the Republic of China (Taiwan) and the Republic of Korea (South Korea). PPC will encourage hospitals to participate in Clinerion’s Patient Network Explorer platform for generation of RWD/RWE and bringing more global studies to hospitals.

 

사후관리에 활용한다는 RWD와 RWE는 무엇일까?

April 28, 2019

실제 진료 환경에서 수집된 보건의료 빅데이터인 RWD와 RWE의 활용에 대한 관심이 확대되고 있다. 우리나라 역시 이는 마찬가지다. 보건복지부는 얼마전 RWD 데이터를 통한 등재 의약품 사후관리방안 계획을 발표하기도 했다.

그렇다면 RWD·RWE의 정의 및 이점과 제한점은 무엇일까. FDA 정의에 따르면 RWD(real-world data, 실제임상자료)는 다양한 자료원을 통해 수집된 환자의 건강상태, 보건의료 전달체계와 관련된 각종 자료들을 의미한다.

Trends in Asia-Pacific Clinical Research (아시아 태평양 지역의 임상연구 동향)

September 17, 2018

Over the past ten years, the clinical trial industry across Asia Pacific has experienced growth faster than other regions and regulatory reforms in a number of countries resulting in significant changes in the industry. Coupled with the growth in the pharmaceutical sales and the level of R&D investment in Asia we are entering an exciting period of growth and innovation that will transform the industry in the region over the next ten years.

의약품 개발 및 임상관련 규제의 변화

August 20, 2018

2016년 11월에 우리나라가 국제의약품규제조화위원회(ICH)에 6번째 회원국으로 가입한 이후, 중국 역시 2017년 6월에 ICH 회원국이 됐다. 그 동안 중국 의약품 시장은 전반적으로 제네릭 시장으로서, 전체 제약 시장의 규모는 미국에 이어 2위로 성장한 반면, 신약 개발 수준은 글로벌 제약사에 비해 훨씬 뒤쳐져 있었다. 그러나, 중국은 향후 제약강국으로서의 경쟁력을 빠르게 키워나갈 것으로 예상되며, ICH 가입에 따라 의약품 허가와 관련한 규제를 국제 표준화에 맞게 변경할 것으로 기대된다.

중국에서의 의약품 개발 및 임상관련 규제의 변화

June 28, 2018

2016년 11월에 우리나라가 국제의약품규제조화위원회(ICH)에 6번째 회원국으로 가입한 이후, 중국 역시 2017년 6월에 ICH 회원국이 됐다. 그 동안 중국 의약품 시장은 전반적으로 제네릭 시장으로서, 전체 제약 시장의 규모는 미국에 이어 2위로 성장한 반면, 신약 개발 수준은 글로벌 제약사에 비해 훨씬 뒤쳐져 있었다. 그러나, 중국은 향후 제약강국으로서의 경쟁력을 빠르게 키워나갈 것으로 예상되며, ICH 가입에 따라 의약품 허가와 관련한 규제를 국제 표준화에 맞게 변경할 것으로 기대된다.

The 10th DIA 2018

June 12, 2018

The 10th DIA which held in BICC from May 23-25, 2018 has successfully convened and satisfactorily concluded. Experts from all walks of life did work shraing and were committed to exploring and promoting future drug innovation in China and globally, colleagues from all sectors joyously gathered for an interdisciplinary academic event.

 

PPC, as a platinum sponsor, actively participated in this grand DIA China Annual Meeting, not only constructed newly designed booth, but also prepared exquisite presents. During the three-day exhibition, PPC booth were always crowded with visitors who constantly came here to talk over with our experts. PPC's unique multi-unit clinical trial solutions attracted many people to stop to consult.

Asia Pharma R&D Leaders’ Summit 2018

April 17, 2018

During Asia pharma R&D leaders’ summit held on 17-18 April 2018 at the InterContinental Shanghai Pudong Hotel, the summit was devoted to exploring and promoting China R&D of novel drugs, as well as international partnership opportunity.           

 

PPC Group had the pleasure to invite Dr. Wu Yan who is head of Clinical operation and immunology development from Hutchison Medipharma, Dr. Pan Ke, CEO of Asieris Pharmaceuticals, Dr. Wu Zheng, CEO of Ark Biosciences, Dr. Mei Jianming, CEO of Antengene and Dr. Ma Zhenkun, CEO of TenNor Therapeutics Limited to participate the panel discussion of the opportunities and impacts of the reforming of CFDA and the Funding for R&D.

Generic International Summit Asia 2018

April 19, 2018

The 8th Generic International summit was held in Shanghai from April 19th to April 20th. Experts from pharmaceutical industry all over the world made a thorough discussion and communication on various topics regarding generic drugs and lead to a success. PPC Group, as one of the co-organizers of the conference, has actively prepared basic knowledge and practical experience about the BE trials.

Dr. Chen Yanan, the Medical Director of PPC, shared with everyone in the clinical and regulatory Session on the topic of “Protocol Design Thoughts and Key Considerations of BE Trials”. Dr. Chen explained the factors that CRO needs to consider when writing the protocol from the background of BE research methods, and Dr. Chen pointed out that normally we need to combine with the pharmaceutical research data of the sponsor, such as dissolving the data of pilot trials, the characteristics of the product itself, and factors such as the selection of the subjects, the difference of human race and the limitation of blood sample analysis when we design the protocol.

BioCon 2018

April 20, 2018

The panel discussion on “In ICH Era, How we Accelerate Clinical Trial Progress to Shorten Development Cycle” was successfully held by PPC Group. PPC invited Patrick Liu, the president of TEVA, and Mr. Sonic Xu, COO of SPH KDL, Ms. Qin Yan, Deputy Chief Physician of CICAMS, Mr. Zhang Xin, Executive Director of Clinical Operation and Regulatory Affairs from Henlius, and Dr. Yu Lixin, CEO of RefDrug to participate the discussion.

 

The discussion focused on the key points and sequence of accelerating the clinical trial process of biosimilar drugs; Phase I study and Phase III Wavier; The selection, sourcing and acquiring of reference drug; Building clinical research team and cooperation with CRO and PI; Selection of investigator sites & cooperation within international multi-centers.

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