PT Equilab International participated in The ICSE, 25-27 October 2011 in Messe Frankfurt, Germany.
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PT Equilab International will exhibit in the upcoming ICSE, 25-27 October 2011 in Messe Frankfurt, Germany.
Please drop by our booth (41E42) for a discussion how Equilab can work with you.
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Equilab Honoured by the Audit Certificate GCP and GcLP from Concept Foundation
On March 21-25, 2011 Concept Foundation, an international Public-Private Partnerships based in Bangkok-Thailand, Geneva-Switzerland, Hanoi-Vietnam, and in ten more countries, conduct an audit of PT Equilab International.
Concept Foundation was established in 1989 and won the trust of the WHO (World Health Organization) to provide pre-qualification of good quality health products to be sold to international markets that focus on low-income countries and drugs which is very necessary.
The purpose of this audit is to know the quality of Equilab pharmacokinetic and clinical laboratories and the quality of Equilab clinic are in accordance with GCP (Good Clinical Practice) and GcLP (Good Current Laboratory Practice) standards, so that the data obtained from PT Equilab able to meet the requirements of the Regulatory Agency Eropean Union (EU).
In order to assure itself of the quality and compliance status of clinical research conducted at Equilab, Concept Foundation asked South Barn Consulting Ltd, Mr. David Bailes, to conduct a service provider of GCP and GcLP audit of the pharmacokinetic and clinical laboratory facilities and clinic at Equilab site. South Barn Consulting Ltd (SBC) is an independent consultancy in the clinical research quality. During the audit only found a few minor discrepancies with the standards of GCP and GcLP and that could be improved.
By gaining audit certificates of GcLP and GCP from Concept Foundation on May 23, 2011 it can be concluded that the pharmacokinetic and clinical laboratory facilities and clinic PT Equilab International is comply with GCP and GcLP and Equilab has a good reputation in international markets. PT Equilab optimistic to compete in global markets both in the field of clinical trials and BA / BE studies (last update: June, 2011).
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Half-Day Seminar "Broadening Knowledge of BA/BE Studies
through Scientific, Ethics, and Regulatory Aspects"
In commemorating the 8th anniversary, PT Equilab International held a seminar with theme "Broadening Knowledge of BA/BE Studies through Scientific, Ethics, and Regulatory Aspects." It was took place on May 25, 2011 at Millennium Hotel, Jakarta. The purpose of the seminar is to ensure that pharmaceutical industries can improve their knowledge and get the latest information about BA / BE study.
Mr Wimala Widjaja as a Director of PT Equilab International opened the seminar and expressed some appreciation of successful accomplishments achieved during the last 8 years both from domestic and international organizations. For example are the audit certificate of GCP (Good Clinical Practice) and GcLP (Good Current Laboratory Practice) awards that recently acquired by Equilab from Concept Foundation, an international Public-Private Partnerships organization based in Bangkok-Thailand, Geneva- Switzerland, Hanoi-Vietnam, and in ten other countries.
Equilab supports the seminar by given variety of interesting materials include:
1. Drug Control Policies and Application of BA / BE Study by Dra.Lucky S. Slamet, MSc. (Deputy for Therapeutic Products and Drug Supervision).
2. The Ethics Aspects of BA / BE Study by Prof. Dr. dr. Rianto Setiabudy, Sp.FK (Chairman of the Ethics Commission).
3. The Scientific and Methodological Aspects of BA / BE Study by Prof. Arini Setiawati, PhD (Professor of Pharmacology, Faculty of Medicine, University of Indonesia).
4. Managing Risk in BE Study through In-Vitro Analysis by Dra. Effi Setiawati, Apt., M. BioMed (General Manager Operations of PT Equilab International).
The seminar was attended by 29 pharmaceutical industries in Indonesia. All seminar participants were very enthusiastic to follow the material presented by all speakers. Feedback and questions from them at the discussion session warms the atmosphere of the event.
Even some of the participants are still trying to discuss with some speakers and staffs about the matter at seminar break. It is an honor for PT Equilab International because Mrs. Lucky S. Slamet is pleased to be a speaker and gave her congratulations to Equilab’s anniversary.
The seminar was closed in the afternoon and end with the giving of thanks and appreciation to the speakers (last update: June, 2011).
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“Managing Risk and Compliance in Bioavailability/Bioequivalence Study” Seminar held by PT Equilab International educate Pharmaceutical Industries in Philippines
90 participant from 56 Pharmaceutical Industries in Philippines filled the Hampton Room, Hotel Astoria Plaza, Ortigas – Manila in “Managing Risk and Compliance in Bioavailability/Bioequivalence Study” Seminar held by PT Equilab International as a collaboration work with Philippines Chamber of Pharmaceutical Industry (PCPI), the Philippines Pharmaceutical Industry organization.
This event took place on January 31, 2008, started from 9 am and opened by Welcoming address from Ms. Marilou B. Buensuceso, President of PCPI, dan followed by Introduction and Company Profile of PT Equilab International presented by Mr. Wimala Widjaja, General Manager of PT. Equilab International. This seminar hosts two core materials, which are Scientific and Ethical Aspect in BA/BE Study dan Managing Risk in BE study Through In-Vitro Analysis. Two keynote speaker Prof. Rianto Setiabudy, Departement of Pharmacology – Medical Faculty University of Indonesia, also consultant of PT. Equilab and Effi Setiawati, Pharm, MSc, BA/BE Business Manager PT. Equilab International, speaking as Chairman of Indonesian BA/BE Working Group were explained deeply about those materi, respectively.
The aim of this seminar is to widen the perspective of Pharmaceutical Industry practition about bioavailability/bioequivalence (BA/BE) study from technically and ethics point of view and also give an education to them about the key factors to avoid the failure risk in conducting Bioequivalence study which is the risk to get bioinequivalent result.
The participant enthusiasm showed since the re-registration opened and continued during discussion session. A lot of interesting questions were asked. Most of them showed their satisfaction by saying how informative and useful the material presented in this seminar considering not many BA/BE laboratory even regulatory body gave the information as complete as this seminar.
Through this seminar, Equilab wants to give beneficial contribution to pharmaceutical industries not only as a promotional event. Equilab wants to show that BA/BE laboratory is supposed to give an integrated and completed services to their customer including being responsible to give continuously consultancy especially how to manage the bioinequivalent risk in bioequivalence study result (last update: January, 2008).
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Equilab International will participate at 11th Asean Consultative Committee for Standards and Quality (ACCSQ) Pharmaceutical Product Working Group (PPWG) Meeting in Hanoi, Vietnam on March 6 – 10, 2006
ACCSQ-PPWG was established in September 1999 in Kuala Lumpur, Malaysia with the objective to develop harmonization schemes of pharmaceuticals' regulations of the ASEAN member countries to complement and facilitate the objective of ASEAN Free Trade Area (AFTA), particularly, the elimination of technical barriers to trade posed by these regulations, without compromising on drug quality, safety and efficacy.
The meeting will be attended by delegates and observers from all the ASEAN member countries, comprising of both regulatory and industry representatives. A staff of the ASEAN Secretariat and a representative from the World Health Organization (WHO) were also in attendance.
Hopefully, Equilab International can contribute in process of harmonization of standardization of bioequivalence (BE) study. This harmonization will facilitate accredited BE centers and pharmaceutical industries to conduct a good quality BE study and its results can be accepted among ASEAN member countries (last update: March, 2006).