October 26th. Co-hosted with Taipei Municipal Zhongshan Girls High School for the first high school campus talk, continue to promote clinical trials knowledge to the senior high school level.
October 13th.-14th. Clinical trial professionals training- ‘Monitoring Hands-on Workshop’.
August 24th. Co-hosted the "Good Submission Workshop" with Taiwan Association of IRBs (TAIRB) to improve the quality of IRB submissions, define clear role and responsibility, share with members, hospital/company colleagues after the workshop, and jointly implement the optimization plan.
November 25th. Implemented electronic election. Completed the 8th Board of Directors and Supervisors election via electronic voting.
October 27th. Campus talk (Clinical Trials Master Your Career) at Fu Jen Catholic University.
October 19th. Hosted ‘Clinical Trials Consensus Symposium- Drive for the Future, Together’. The meeting took 6 months to prepare, had 14 pre-meetings with the representatives across government, hospitals and institutions, and formed a working group with members from three host associations. Representatives from various sectors participated on the day of the meeting, 30 joined in person and 60 joined online. Consensus on the three topics (Excellence in IRB review; New Normal- through the pandemic and beyond; Patient Access) was reached successfully. An advice proposal is available for the participating sectors as reference for advocacy and implementation moving forward.
October 7th.-8th. Clinical trial professionals training- ‘Monitoring Hands-on Workshop’.
June 10th. Drove for approval from Central Epidemic Command Center to prioritize COVID-19 vaccination for front line clinical trial professionals, while coordinate with institutions to expedite vaccine administration. This is to ensure accurate clinical trial conduct according to the protocols, and to protect subject safety and well-being.
Special thanks to assistance from the government, as well as to Shuang Ho Hospital Clinical Trials Center (CTC), Hualien Tzu Chi Hospital CTC, Taipei Veterans General Hospital, National Taiwan University Hospital and National Cheng Kung University Hospital for creating COVID-19 vaccination name list for front line clinical trial professionals.
May 19th. Successfully enrolled in the participant list of a joint conference between the Taiwan Food and Drug Administration Pharmaceutical Sector and the Pharmaceutical associations. Communicated with pertinent government sectors proactively to work towards a better clinical trial environment in Taiwan.
December 23rd. Visited Yueh-Ping Liu, Director of Ministry of Health and Welfare, to discuss topics including ’not limit clinical trials subsequent submission reviews to the original group of reviewers’, ‘execution of ICH E6R2 GCP in practice ‘, ‘Suggestions and Principles for the Implementation of Drug Clinical Trials during the Prevention of Severe Pneumonia with Novel Pathogens (COVID-19)’, ‘increase opportunities for subjects to participate in clinical trials’. The Director recommended scheduling a consensus meeting in the coming year in order to achieve agreement among various parties and aid in future implementation.
This visit created the opportunity for the ‘Clinical Trials- Drive for the Future, Together’ meeting in 2021, co-hosted by TCRA, Taiwan Association of IRBs (TAIRB) and International Research-Based Pharmaceutical Manufacturers Association (IRPMA), where the government, the medical professional and the pharmaceutical industry were also invited to take part in.
November 23rd. Established ‘TCRA Director, Supervisor and working group member guideline’ and create On-boarding Training, in order to define role and responsibilities, to enable clear communication and efficient operation.
November 17th. Campus talk (Clinical Trials Master Your Career) at National Tsing Hua University.
November 3rd. Public health education at Shuang Ho Hospital.
October 21st. Updated official website, implemented electronic process such as meeting admission and electronic financial process. This upgrade to the website enhanced its convenience of use and efficiency, and it's at the same time, energy saving, carbon reduction, earth loving.
September 3rd.-4th. Clinical trial professionals training- ‘Monitoring Hands-on Workshop’.
August 7th. Resumed periodic conversation with Taiwan Association of IRBs (TAIRB), discuss current clinical trial environment issues with TAIRB on a continuous basis, around every 3 months.
Added Growth & Learn Session to the Directors and Supervisors meetings, for the Directors and Supervisors to not only work together but grow together as well.
August 2nd. Public health education at Taipei Veterans General Hospital.
June 25th. Clinical trial professionals training- ‘Issue Management Workshop’.
June 5th. Campus talk (Clinical Trials Master Your Career) at National Yang-Ming University.
May 29th. Campus talk (Clinical Trials Master Your Career) at National Taiwan University.
November 9th. Clinical trial professionals training- ‘Issue Management Workshop’.
September 7th. Public health education at Hualien Tzu Chi Hospital.
August 16th. Clinical trial professionals training- ‘GMP Training & Clinical Supply Workshop’.
Proactively drove the initiative of standardizing IRB submission forms and supporting documents, and an absolute paperless submission process.
Supported the Ministry of Health and Welfare and the Taiwan Food and Drug Administration to include the following items at the Medical Affairs and Pharmaceutical Affairs joint meeting on August 15th:
1. Include IRB review efficiency as part of hospital accreditation for Medical Centers.
2. Plan to invite relevant Medical Centers to comment on Multiregional Clinical Trial (MRCT) review process.
3. Introduce a template for IRB submission form and include it in the IRB checkup agenda.
4. Set up electronic system for submission in order to increase clinical trial submission review efficiency and advance Taiwan’s overall competitiveness internationally.
September 21st. Public health education at Taipei Municipal Wanfang Hospital.
August 17th. Clinical trial professionals training- ‘GMP Training & Clinical Supply Workshop’.
July 26th. Public health education at China Medical University Hospital.
April 26th. Public health education at Taipei Veterans General Hospital.
December 12th. Public health education at Kaohsiung Medical University Chung-Ho Memorial Hospital.
June 15th. Public health education at Chang Gung Medical Hospital, Linkou.
June 14th. Clinical trial professionals training- ‘GMP Training & Clinical Supply Workshop’.
April 13th. Public health education at National Cheng Kung University Hospital.
March 31st. Publish TCRA new logo. This aided in branding the association on its advocacy moving forward.
October 14th. Public health education at National Taiwan University Hospital.
Built ‘EMR System Survey Form’. This was to aid in understanding and recording electronic chart systems at each institution, in turn this would save manpower and time for both the institution and the pharmaceutical company.
October 9th. ‘ Electronic Medical Record for Clinical Trial Workshop ’
June 6th. Clinical trial professionals training- ‘GMP Training & Clinical Supply Workshop’.
Established ‘Taskforce’: Divides the work and work in teams to better focus and advocate for clinical trial related matters. Hopes to enhance our abilities in clinical trial conduct through the participation and collaboration from each member companies. As well as maintain positive interaction and communication with organizations such as relevant competent authorities, institutions and other associations.
August 10th. Hosted ‘EMR Workshop’. Special thanks to Ministry of Health and Welfare, Taiwan Food and Drug Administration, National Taiwan University Hospital, Chang Gung Memorial Hospital, Chung Shan Medical University Hospital, Chi Mei Hospital, Yonglin HealthCare Foundation in joining this event to drive the usage of electronic medical record.
November 4th. Launched TCRA official website www.tcra-org.tw
July 31st. Established Taiwan Clinical Research Association, TCRA.
Goal is to advance clinical research environment and new drug development in Taiwan, to enhance clinical trial quality and standards, and to align with the world. This was the first nonprofit organization comprised of a full range of companies with different interests that conduct clinical trials.
October 13th. Established Medical Affairs Association, MAA, predecessor of TCRA.
Goal was to enhance clinical trial quality and standards by academic interactions and experience sharing, to represent member companies to communicate and resolve clinical trial conduct issues with collaborating organizations, to look out for member company rights and assist in growth among members.