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Training

MedResNet leading providers of clinical research training center in Thailand. We provide clinical research education and customized training to research sites across the country which are Basic ICH-GCP E6(R2), Advance GCP, Training for Study Nurse & Coordinator, CRA Course, Clinical Project Management, Protocol Development and Training for Clinical Research Center (CRC).

Course

Basic ICH-GCP E6(R2)

Good Clinical Practice (ICH-GCP, E6R2)

This GCP training course covers the ICH-GCP (E6-R2) international guidelines and meets the training requirement for you to participate in international clinical trials.

This GCP training course is an up-to-date guide to the international ICH-GCP (E6-R2) guidelines. It is essential for anyone taking part in the running of a clinical trial. The course was written by an expert with over 30 years’ experience. Our ICH GCP training course is accepted worldwide as it meets the TransCelerate Biopharma mutual recognition criteria. Upon successful completion the training and completed quizzes, a certificate is provided.

 

  • Course learning objective
    • Describe the foundations, background, principles and application of ICH GCP
    • Identify key international and local regulations that impact the conduct of clinical trial
    • Recognize the importance of complying with ICH GCP, as well as the impact of noncompliance
    • Describe ICH GCP key roles and responsibilities in the conduct of clinical trials

 

  • Who should attend
    • Anyone taking part in the running of a clinical trial, which are investigator, sponsor, and IRB/EC member

 

  • Course topics
    • Introduction & principles of ICH-GCP
    • Institutional Review board/ Ethics committee
    • Informed consent
    • Safety reporting
    • Roles & responsibility of investigator and sponsor
    • The research protocol
    • Quality management in clinical trial
    • Investigational product and country regulations

Advance GCP

Advance Good Clinical Practice

คุณสมบัติของผู้ที่เหมาะสมในการอบรม

             ผู้ที่เคยผ่านการอบรม Basic GCP หลักสูตรพื้นฐาน หรือผู้ที่มีประสบการณ์การ  ทำงานวิจัยคลินิก

รูปแบบการจัดอบรม

            Workshop

จำนวนผู้เข้าอบรม

ไม่เกิน 30 ท่าน

เนื้อหาหลักสูตร 1 วัน

            จะมีการสรุปเนื้อหาของ Basic GCP และ จัดกิจกรรม Workshop โดยเน้นเนื้อหาตามความต้องการของผู้เรียนเป็นสำคัญ สามารถเลือกเนื้อหาที่สนใจได้ 2-3 เรื่อง ดังต่อไปนี้

  1. Protocol compliance, and non-compliance management
  2. ICF and recruitment
  3. Source document, data collection and query management
  4. Investigational product handling
  5. Safety detecting and management
  6. Essential document
  7. Quality management in clinical trial
  • 7.1 Monitoring
  • 7.2 Audit and inspection
  1. Data quality and integrity
  • 8.1 CRF and source data
  • 8.2 Data collection and data management
  • 8.3 Data quality

Training for Study Nurse &Coordinator

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CRA Course

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Clinical Project Management

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Protocol Development

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Training for Clinical Research Center (CRC)

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Trainer Bio.

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2017-present

Key Responsibilities :
• Manage the overall operation of organisation
• Serve as consultant to both government and private organisation on drug development, planning for clinical research to product registration
• Provide guidance to Thai researcher for product development, life cycle management, product registration
• Be part of the organisation to support the national research strategy
• Train both government and private organisation in drug development, clinical research, project management

Key Achievement :
• Involve in setting up the national clinical centre network
• Involve in drafting the curriculum for clinical research centre
• Involve in national project that lead to improvement of health policy, treatment and evaluation trend of disease condition in Thailand
• Establish the collaboration with international organisation for research and drug development e.g. Japanese, Chinese and Korean both government and private sectors

Internship

Medical Research Network, MedresNet is an organization to support the clinical research network in Thailand, to develop system and facilitate the collaboration for national and international clinical research.

Another mission is training and education, MedResNet collaborate with Faculty of Pharmacy to serve as the clinical instructor and trainer for the Clinical Research Internship Programme.  The 6th year Pharmacy student who interest and keen to know about the Clinical Research can select as their rotation.  The programme is the combination of course work, workshop, assignment and real work with the Clinical Research Associate (CRA).  During the course the intern will learn from Drug Development process, the overall of clinical research from planning, execution through the close out of the study.  The programme has been continuing for 3 years and there have been 27 interns from Mahidol and Srinakarindwiroj Universities completed the training.  In 2018 MedResNet welcome Chulalongkorn and Prince of Songkla University to join the programme.

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2020

Section 2-3

Srinakharinwirot University

  1. Miss Chanakan Deekiatlum
  2. Miss Bunyanit Arthamanolap
  3. Mr. Thanatip Sunun
  4. Mr. Pongthorn Buasuwan
  5. Miss Suchanya Shaoprasert

Silpakorn University

  1. Miss Kanika Kabkaew
  2. Mr. Thanathorn Krooprasert
  3. Mr. Jitrin Fongsataporn
  4. Mr. Kasiew Lee

Chulalongkorn University

  1. Mr. Natthapong Nonpat

Mahidol University

  1. Miss Yanika Chuachan
  2. Miss Pinyapat Sukmunkongsamer
  3. Miss Siraphat Phetsiri
  4. Miss Arisa Chandrswang

Prince of Songkla University

  1. Miss Chutima Bunnab
  2. Miss Kanthika Nithetphattaraphong
  3. Miss Saitharn Khanthasak
  4. Miss Praeploy Sinthusarn

Section 5-6

Silpakorn University

  1. Miss Kojchakorn Samartlertdee
  2. Mr. Komchan Somsook

Chiang Mai University

  1. Miss Panisa Klowutivat
  2. Miss Saranporn Wiangngoen

Mahidol University

  1. Miss Supakarn Satthanon
  2. Mr. Tharaphong Khamenkarnthai

Prince of Songkla University

  1. Mr. Prueth Jarupanich

Section 7-8

Srinakharinwirot University

  1. Miss Natthanun Chanthichkijroongruangpaisan
  2. Miss Nonpan Keereerat

Mahidol University

  1. Miss Usanisa Woradirake
  2. Mr. Jakkrit Chokchai

Prince of Songkla University

  1. Miss Nattanicha chutip
  2. Miss Sireethorn Jarasjindawong

Chiang Mai University

  1. Mr. Tachin Taweesap
  2. Miss Kittiwara Kawila

2019

Section 1-2

Chulalongkorn University

  1. Mr. Phongsathorn Udomthaweesup

Mahidol University

  1. Miss Vorranitta Sriwattanavanit
  2. Miss Sasinun Wasinapinun

Prince of Songkla University

  1. Miss Chanikarn Klubwongsa
  2. Miss Cholada Tantapakul

Silpakorn University

  1. Miss Sujitra Khamdee
  2. Miss Sasiwan Rattanapol

Srinakharinwirot University

  1. Miss Supawan Chalermnithiwongs

Section 4-5

Srinakharinwirot University

  1. Mr. Tanapat Suksomboon

Mahidol University

  1. Miss Chatnaree Sukcharoenpong
  2. Miss Sutthiporn Phannachet

Prince of Songkla University

  1. Miss Panisa Pachmanee
  2. Miss Panisara Tuanweeradet

Silpakorn University

  1. Miss Wanrada Meela
  2. Mr. Adunwit Phumphuang

Section 6-7

Chulalongkorn University

  1. Miss Chayapa Patthamung

Mahidol University

  1. Miss Yanisa Achayawat
  2. Miss Sorraya Sukkho

Prince of Songkla University

  1. Miss Roongrat Klaklangchon
  2. Miss Araya Wongmek

Silpakorn University

  1. Miss Thitipanchaya Panya
  2. Miss Chutima Piyasuwan

2018

Section 1-2

Chulalongkorn University

  1. Miss Parida Tonusin

Mahidol University

  1. Miss Kingkan Raethong
  2. Miss Phanthila Supattarasakda

Srinakharinwirot University

  1. Miss Sireethorn Poomborplab
  2. Miss Thanjira Saksilaporn

Section 4-5

Mahidol University

  1. Miss Thanaporn Sangdet
  2. Miss Fueangfa Phetpradabfa

Silpakorn University

  1. Mr. Peemagorn Orgid

Prince of Songkla University

  1. Miss Panpitcha Worarattananurak

Section 6-7

Mahidol University

  1. Mr. Nutthanon Yaemsai
  2. Miss Tanyarat Pattanasittipong

Srinakharinwirot University

  1. Miss Rosarin Jira-arnon

Prince of Songkla University

  1. Miss Anis Siripitayanon

2017

Section 1

Mahidol University

  1. Mr. Thanakorn Vongjarudech
  2. Miss Pornnatcha Pongtananonkun

Section 2-3

Srinakharinwirot University

  1. Mr. Peerawit Nittayanonte

Section 3

Mahidol University

  1. Miss Monsikan Jaisuda
  2. Miss Sasikarn Siwapinyoyos

Section 4-5

Srinakharinwirot University

  1. Mr. Peerapol Chusilpsakul
  2. Miss Kanakan Kingchan

Section 5

Mahidol University

  1. Miss Nichaphon Hongsa
  2. Miss Suvichada Assawakosri

2016

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2015

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ตัวอย่าง Certificate หลักสูตร ICH-GCP E6(R2)

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Cert_BasicGCP_2020

Clinical Trial Regulation Related

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