Become a certified clinical research and PVG professional

Catalyst Clinical Research Services
Leading Clinical Research and Pharmacovigilance Training Providers

www.catalystclinicalservices.com

info@catalystclinicalservices.com

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Now, you can boost your career growth by becoming a certified clinical research and pharmacovigilance professional. You can learn effective good clinical practices, clinical trials and pharmacovigilance skills by participating in one or more of the courses listed below:

  1. Professional Diploma in Clinical Research (PDCR)
  2. Professional Certificate in Pharmacovigilance (PCPV)
  3. Certificate Program in Scientific Writing (SW)
  4. Certificate Program in Project Management (PM)
  5. Certificate Program in Clinical Trial Management (CTM)
  6. Oncology Clinical Trials Training (OCTT)

With a participation of more than 9000 candidates across 27 countries over the last 14 years, these courses have received wide acclamation from the key stakeholders. Majority of the successful participants are employed across 300+ organizations.

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Professional Diploma in Clinical Research (PDCR)
Duration:
6 months; Eligibility: B.Pharm 3rd year onwards; Fee: Rs. 9600
Module-1: Introduction to Pharmaceutical Medicine

  • The Drug Development Process
  • New Drug Discovery
  • Clinical Development of Drug
  • Essential Clinical Trial Documents
  • Clinical Trials Terminology

Module-2: Good Clinical Practice (GCP) Foundations

  • History of GCP - milestones in the evolution of GCP
  • Principles of GCP and applicable GCP Guidelines
  • Declaration of Helsinki
  • Clinical Study Process
  • The Management of Clinical Studies (Sponsor)
  • Ethics in Clinical Research
  • Informed Consent
  • Serious Adverse Event (SAE)
  • Challenges in the Implementation of GCP Guidelines
  • Biostatistics

Module-3: Drug Regulatory Affairs (Clinical Trials)

  • Overview of Regulatory Environment in USA, Australia, Europe and India
  • Clinical Trial Application Requirements in India
  • Import-Export of Clinical Trial Drugs in India
  • Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.
  • IND/ANDA/New Drug Application

Module-4: Roles and Responsibilities of Clinical Trial Personnel

  • Roles and Responsibilities of Sponsor
  • Roles and Responsibilities of Investigator
  • Roles and Responsibilities of ERB/IRB/IEC
  • Roles and Responsibilities of CRA /Monitor/Auditor/ Clinical Research Coordinator
  • Roles and Responsibilities of CRO
  • Roles and Responsibilities of Regulatory Authorities
  • Roles and Responsibilities of Clinical Data Manager (CDM )
  • Roles and Responsibilities of Clinical Biostatistician

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Professional Certificate in Pharmacovigilance (PCPV)
Duration:
6 months; Eligibility: B.Pharm 3rd year onwards; Fee: Rs. 9600

Training Topics:

  • Introduction to Pharmacovigilance (PV) and Risk Management
  • Standard Terms and Definitions
  • Global Perspective of PV and ADR Reporting

- Basic Steps in Setting-up PV Centre
- How to Join WHO NPP
- Practical Procedure for Joining WHO Drug Monitoring Program (ASCoMP)
- Pharmacovigilance Methods

  • Guidelines and Standard Governing PV-ICH Guidelines, US FDA Guidelines, CFR, EU Guidelines, CIOMS Guidelines
  • Global AE reporting System and Reporting Forms

- Introduction and Definition of AE
- Introduction and Aspects Related to AE Reporting
- Pre and Post Marketing Approval of a Drug
- AE Reporting Procedure
- AE Reporting Form

* US FDA Form 3500 and 3500A
* Vaccine Adverse Event Reporting System (VAERS)
* Medicines and Healthcare Products Regulatory Agency’s Vigilance Reporting Form
* Medeffect Canada and Canada Vigilance Program
* Suspected Adverse Drug Reaction Reporting (SADRR) Form
* Universally Accepted ADR Reporting Form CIOMS I Form
* Therapeutic Good Administration Australian Vigilance System –Blue Card

  • Individual Case Safety Reports (ICSRs)
  • Medical Directory for a Drug Regulatory Activities (MedDRA)
  • Periodic Safety Update Reports (PSURs)
  • Expedited Reporting and Requirements
  • PV Inspection and Compliance Monitoring

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Highlights of Training Courses:
* Ease of training (distance learning)
* Assignment based evaluation
* Optimal course fee
* Hand-on practical training component
* Industry-wide recognition
* Placement assistance via job openings on WhatsApp almost on daily basis
* Successful participants employed across 300+ organizations

Kindly get in touch at +91 9818356273 or mail at info@catalystclinicalservices.com to get further details of the courses.

Catalyst Clinical Services Pvt. Ltd.
Unit No. 11, CSC-12, Block-D1, Sector-16, Rohini, Delhi - 110089
M: 9818356273, 8826806862 (voice call and WhatsApp)
Email: info@catalystclinicalservices.com
Leading Clinical Research and Pharmacovigilance Training Providers

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