Last January 24th, the Philippine Clinical Research Professionals, Inc. (PCRP) held its 2020 General Assembly with the theme, “Philippine Clinical Trial: Interdependency, Connection, and Growth”. The assembly was held in Manila Doctors Hospital and was attended by 134 members.
PCRP President, Mr. Rodmar Pulido opened the event and shared the Board of Directors’ (BOD) goals for the organization. The BOD’s plan is to focus on strengthening member engagement – which include continuing company membership, revitalizing the leader’s network, establishing overseas bureau, and boosting the organization’s social media presence. Mr. Pulido is also persistent in continuing the last BODs’ initiative such as the program on building up the vaccine clinical trial in the country, as well as the patient awareness campaign.
As part of the 2020 goals, the board is exerting its effort to gain government attention for clinical trials. This plan includes collaborating with Healthcare Information Management Association of the Philippines, Inc. or HIMAP. HIMAP represents the Philippine Healthcare Information Management Services in the global market. During the event, the HIMAP President, Ms. Maria Cristina Coronel talked on how HIMAP can promote the clinical trial industry in the global market. With these efforts, the clinical trial industry in the Philippines can even go greater. Other speakers invited in the assembly were: Mr. Jefferson Tan, who presented an interesting topic on Data Analytics; Ms. May Chelle Baay who shared her expertise on project management; Ms. Maria Melody Socorro Lagrimas who spoke about her experience and passion in data management; Dr. Evangeline Costelo who discussed about the role of a medical monitor; Dr. Avigail Martha Pastoral-Peco who explained pharmacovigilance; and Mr. Al Ryan L. Baniqued who facilitated the best practice sharing for import and export permit.
Also graced the event is the head of Single Joint Research Board (SJREB), Dr. Jacinto Blas Mantaring III. The SJREB is a joint review mechanism among PHREB duly accredited Research Ethics Committees of DOH Hospitals. He discussed the SJREB full board review process flow which can be done by parallel submission of the study protocol to SJREB and the site Research Ethics Committee.
The Deputy Director General of FDA, Ms. Maria Lourdes Santiago also provided the changes in FDA regulation. Currently, according to FDA Circular 2012-007 A, the process turn-around time was sped up from 120 days to 75 days. To compensate with this change, the regulatory fee increases from PHP 30,000.00 to PHP 60,000.00. With the new scheme, their current data shows and average of 54 days processing time (with a range of 39 -102 days). This year, the administration is proposing a new regulation, in which the processing time for the review of protocol can still be shortened up to 60 days (from 75 days) wherein electronic submission is also being considered.
This event was also made possible with the generosity of the following sponsors: Manila Doctors Hospital, Royal Cargo, and Triload Logistics Corp.
Aside from the various talks from speakers, this assembly became a venue for PCRP members to share the best practices of their companies to improve the operation and management of clinical trials in the Philippines. The Philippine clinical trial industry and its growth is indeed interdependent on various organizations and government agencies and to not limit its growth, the industry must be bold in building stronger connections.