The workshop is from 24^th - 26^th, September 2010 at the Oscar-Saigon Hotel, Ho Chi Minh City, Vietnam.

This is an approved ICH-GCP workshop by the Ministry of Health (MOH), Vietnam and endorsed by Murdoch University, Western Australia.

Workshop Highlights:

Ø  Introduction to Clinical Research.

Ø  Understand the Principles of ICH-GCP.

Ø  Role of Ethics Committee.

Ø  Elements of Informed Consent.

Ø  The Responsibilities & Golden-Rules of Sponsor, Investigator and Study Monitor.

Ø  Safety Reporting.

Ø  Handling of Biological Specimens.

Ø  Recruitment Strategies.

Ø  Good Documentation Practice

Ø  Good Clinical Trial Site

Ø  Introduction to Bioavailability and Bioequivalence Studies.

Key Highlights:

·         Approved ICH-GCP workshop by the MOH, Vietnam & endorsed by Murdoch University, Western Australia.

·         Listen to Invited International & Local Speakers from the Academia, the MOH, Vietnam; the Pharmaceutical Industry and the Clinical Research Organization.

·         Excellent location: Oscar-Saigon Hotel, District 1, HCMC, Vietnam.

Wait no more and mark your calendar…! 24^th – 26^th September 2010

Contact us at:

+84-903-623249 letrinhmrc@yahoo.comvn (Vietnam) or

+62-21-5207739 deny_l@gleneaglescrc.com (outside Vietnam)

Download Flyer & Registration Form [flyer-gcp-workshop-vietnam-26jul2010]

A mandatory workshop for Quality Research Coordinator!

17 - 19 June 2010, Penang, Malaysia

A successful clinical trial is supported by a well trained and knowledgeable study team working hand in hand. Study coordinator or research nurse plays an important role in the study team, being the left and right hand of the principal investigator. This workshop aims to prepare and build up individual capabilities in new technology for a research position at any phase of Good Clinical Practice (GCP) trials with minimal supervision after the completion of the training.

Download the registration form through the link here [Emerge Through Us]

Need further information, contact Ms Karen Teh or Ms Leong Bee Yong

This training is jointly organized by Info Kinetics, Associates of Clinical Research Professional (ACRP) & MOH CRC

Info Kinetics and Penang Development Corporation (PDC) join hands with Malaysian Biotechnolgy Coporation for the Biotechonology Entrepreneurship Special Training (BeST) Programme.

The BeST programme is an intensive, structured programme for graduates with entusiasm and deep interest to join the biotechnology industry.

Info Kinetics is appointed to facilite the module on Clinical Resarch. The pioneer batch of 40 participants had completed their training in March 2010. To learn more about the training agenda and opportunities, check out BiotechCorp’s website: www.biotechcorp.com.my

Nurturing Biotechnology Talent

Date: 03-04 December 2009

Venue: Borobodur Hotel, Jakarta

For further information, please contact Deny Lingga (deny_l@gleneaglescrc.com).

GCP Workshop 2009, Jakarta

What is this study about?

The acute inflammation of nose and throat regions (acute rhinopharyngitis) with symptoms such as nasal congestion, runny nose, sore throat and headache, is one of the most common illnesses worldwide. Though mostly caused by viruses, these infections are often treated unnecessarily with antibiotics in the beginning stages. Therefore, alternative therapy concepts, e.g. therapy with herbals are desired both by doctors and patients. Purpose of this study is to determine whether EPs® 7630 film-coated tablets possess a beneficial effect in the therapy of acute rhinopharyngitis (inflammation of nose and throat), as well as the safety and tolerability.

Who is eligible?

Those who have symptoms (such as nasal discharge, sore throat, sneezing, nasal congetion, scratchy throat, hoarseness , cough, headache, or fever) for less than 72 hours and NOT on any medication.

Need more information? Call us at 017-478 0390

This trial will end on September 2009.

• Sustainablity of pharmaceutical healthcare requires sustainability of a strong competitive and financially healthy EU generic industry.
• The EU off-patent market must be based on the principle of “headroom for competition”.
• Ensure that no regulatory, patent or market hurdles exist to the immediate entry of generic medicines on patent expiry
• Introduce mechanisms to stimulate competition from generic medicines
• Create a price & reimbursement system for long term competition, not short term savings

Follow the European Commissions’ inquiry and report here Press Release 8th July 2009

If you are a patient and have interest in participating in these clinical trials, please feel free to contact us for further details (admin@info-kinetics.com)

A Randomized, Open-Label, Multicentre, Phase 3 Study of Epoetin Alfa plus Standard Supportive Care versus Standard Supportive Care in Anemic Patients With Metastatic Breast Cancer Receiving Standard Chemotherapy. (EPO-ANE-3010)

1.What is this study about?

Anemia is a common complication of the treatment of metastatic breast cancer and it related to the effects of chemotherapy and to chronic disease itself. The purpose of this study is to examine the safety and impact on tumor progression of epoetin afla plus standard supportive care (packed red blood cell transfusions) versus standard supportive care alone, when used to treat anemia according to label guidance. This study will be done in patients with metastatic breast cancer with anemic receiving first-line or second-line standard chemotherapy.

Who is eligible?

Metastatic breast cancer patients with anemic receiving first-line or second-line standard chemotherapy

An international multi-centre open-label 2-arm phase III trial of adjuvant bevacizumab in “triple negative” breast cancer. (Beatrice study, BO20289)

2.What is this study about?

This 2 arm open-label study will evaluate the efficacy and safety of the addition of Avastin (bevacizumab) to standard adjuvant therapy in patients with triple negative breast cancer. Patients will be randomized to receive either standard chemotherapy (anthracycline +/- taxane or taxane only), or standard chemotherapy given concurrently with 1 year of Avastin.

Who is eligible?

Patients with operable primary invasive breast cancer, completed definitive local-regional surgery and primary tumor confirmed as triple negative.

A phase II Biomarker Identification Trial for Erlotinib (Tarcevaâ) in Pateints with Advance Pancreatic Carcinoma. (MARK study BO21129)

3.What is this study about?

This study is designed to identify biomarkers which may predict improvement in progression free survival from treatment with Tarceva, in patients with advanced pancreatic cancer who failed one prior regimen of standard chemotherapy or who are deemed unsuitable for chemotherapy. It will also assess the efficacy and safety of Tarceva in this patient population. Patients will be randomized to receive either Tarceva placebo daily. Tumor tissue will be used for biomarker analysis.

Who is eligible?

Patients with metastatic pancreatic cancer who failed at least one prior chemotherapy regimen or deemed unsuitable for chemotherapy.

A Randomized, Open-Label, Multicentre Phase 3 Study of the Combination of Rituximab, Cyclophosphamide, Doxorubicin, VELCADE, and Prednisone (VcR-CAP) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Patients With Newly Diagnosed Mantle Cell Lymphoma Who Are Not Eligible for a Bone Marrow Transplant (26866138-LYM-3002)

4.What is this study about?

Mantle cell lymphoma is an incurable subtype of non-Hodgkin’s lymphoma that was recognized as a unique clinicopathologic entity in the 1990’s. This study is to compare the efficacy and safety of two chemotherapy regimen (VcR-CAP versus R-CHOP) in patients who have newly diagnosed mantle cell lymphoma stage II, III or IV and who are ineligible to undergo bone marrow transplantation, as assessed by significant prolongation of progression free survival.

Who is eligible?

Patients who are diagnosed with Mantle Cell Lymphoma (stage II, III or IV) with at least 1 measurable disease and not eligible for bone marrow transplantation as assessed by treating clinician.

A Multinational, Randomized, Double Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AVE5026 in the Prevention of Venous Thromboembolism (VTE) in Cancer Patients at High Risk for VTE and Who Are Undergoing Chemotherapy (SAVE-ONCO, EFC 6521)

5.What is this study about?

This study is to compare the efficacy of AVE5026 versus placebo in the prevention of VTE in cancer patients at high risk for VTE and who are undergoing chemotherapy. The secondary objectives are to evaluate the safety of AVE5026, to document AVE5026 exposures, to try identifying a metagene predictor of VTE and to assess the survival status at one year in this population.

Who is eligible?

Cancer patients with metastatic or locally advanced solid tumor of lung, pancreas, stomach, colon/rectum, bladder or ovary, who are at risk for VTE and receiving a (new) course of chemotherapy with a minimum intent of 3 months therapy.

Efficacy and tolerability of EPs® 7630 film-coated tablets in patients (≥ 18 years old) with acute rhinopharyngitis (701004.01.009)

6.What is this study about?

The acute inflammation of nose and throat regions (acute rhinopharyngitis) with symptoms such as nasal congestion, runny nose, sore throat and headache, is one of the most common illnesses worldwide. Though mostly caused by viruses, these infections are often treated unnecessarily with antibiotics in the beginning stages. Therefore, alternative therapy concepts, e.g. therapy with herbals are desired both by doctors and patients. Purpose of this study is to determine whether EPs® 7630 film-coated tablets possess a beneficial effect in the therapy of acute rhinopharyngitis (inflammation of nose and throat), as well as the safety and tolerability.

Who is eligible?

Those who have symptoms (such as nasal discharge, sore throat, sneezing, nasal congetion, scratchy throat, hoarseness , cough, headache, or fever) for less than 72 hours and NOT on any medication.

A randomized, double blind, controlled study on the effect of a Growing up milk on the occurrence of infections in toddlers (Tod.1.C/D)

7.What is this study about?

In many countries, infants and young children often attend daycare centres. It has been well documented that daycare attendance increases the risk of infections especially respiratory infections and gastrointestinal infections. The purpose of this study is to investigator the effect of a renewed formula milk on the occurrence of infections in healthy toddlers attending daycare centres.

Who is eligible?

Children aged between 13 to 29 months old who attend daycare centres (with > 20 children in total) at least 2 times a week.

The conference was officiated by Tan Sri Dato’ Seri Hj Dr Ismail Merican, DG of Health Malaysia.

Engaged visitors

“…one has to recognise that modern medicine is evidence based and we would not be able to progress unless we discover and prove new therapies that are more effective. Without medical research, our profession and patient would still be subject to outdated treatments and drugs. In this modern era, cutting edge clinical research avails our patients of the latest drugs and our physicians keep themselves updated on the latest progress.”…Tan Sri Dato’ Seri Dr Ismail Merican.

Date: 29th September 2009 (Tuesday)

Time: 8:30 am – 5:30pm

Venue: Crystal Crown, Petaling Jaya

More details of this module will be available soon. Contact mike@mopi.org.my to book your places.