COURSE TITLE : DIPLOMA PROGRAM IN CLINICAL RESEARCH

COURSE DURATION : 3.5Months.

COURSE GLOBAL CODE : DDP01CR

ABOUT THE CLASS:

This class covers the responsibilities and actions of a study coordinator. It includes conceptual Lectures on roles and responsibilities of the site and sponsor, a summary of the current regulatory environment, overview of Good Clinical Practices (GCP), study initiation activities, monitoring activities auditing activities and SOP requirements. The class is a mixture of lecture and break-out team exercises designed to challenge the participants in the various roles and responsibilities of a clinical research coordinator.

FUNCTIONALITY COVERED...

• • Overview of the clinical trial process
• • Categories of the Clinical trials
• • Regulatory Requirement
• • ICH-GCP industry to guidance
• • Informed Consent Process
• • Study Implementation
• • Monitoring Activities
• • Auditing Activities
• • Standard Operating Procedures (SOP)

WHO SHOULD ATTEND?

Graduates from Life sciences, Medical Doctors, Pharmacy graduates....

COURSE TITLE : DIPLOMA PROGRAM IN CLINICAL DATA MANAGEMENT (CDM)

COURSE DURATION : 3 .5 Months.

COURSE GLOBAL CODE : DDP02CDM

ABOUT THE CLASS:

This class covers the basic Concepts of clinical research related functions like categories of clinical trials, phases of clinical trials, design of clinical trials, CDMS (Clinical Data Management System) DMP (Data Management plan ) etc.. The class is a mixture of lecture and break-out team exercises designed to challenge the participants in the various roles and responsibilities of a clinical Data Manager. This class also covers the basic functionality of Oracle Clinical and consists of presentations, lectures and Hands -on Exercises. Each participant will be allowed and connected to Oracle Clinical live databases.

FUNCTIONALITY COVERED...

• • Overview of Clinical Research/Study/Trial process
• • Categories of the Clinical trials
• • Regulatory Requirement
• • GCP Overview
• • Role of FDA
• • 21 CFR Part 11 requirements.
• • EDC (Electronic Data Capture)
• • CDISC Standards – Past, Present and Roadmap
• • Where CDISC standards fit in the lifecycle of data
• • Introduction to ODM, SDTM and ADAM
• • DMP (Data Management Plan)
• • GCDMP – Good Clinical Data Management Practices.

SQL/PLSQL

Hands on Experience on Data Analytics tool.

CDISC, CDASH Standards.

Hands- on Experience on Oracle Clinical 4.5 Rel

LEARN HOW TO......

• •Navigate through the Oracle Clinical application
• • Define standard objects in the Global Library
• • Design studies in Oracle Clinical
• • Enter patient data in the database
• • Write validation and derivation Procedures
• • Resolve discrepancies
• • Set up labs and normal lab ranges
• • Lock and freeze studies

WHO SHOULD ATTEND?

Life Science graduates, Medical graduates and Medical Doctors, Pharmacy graduates, Clinical Research Professionals, Statistical programmers, People with no prior Data Management experience are also eligible but basic knowledge about Clinical Research Concepts is desirable.

Graduates from Life sciences, Medical Doctors, Pharmacy graduates....

COURSE TITLE : DIPLOMA PROGRAM IN PHARMACOVIGILANCE

COURSE DURATION : 3.5 Months

COURSE GLOBAL CODE : DDP03PV

ABOUT THE CLASS:

This class covers the basic Concepts of clinical research related functions like categories of clinical trials, phases of clinical trials, design of clinical trials, CDMS (Clinical Data Management System),Basic Epidemiology priniciples,different methods of pharmacovigilance,ADRreporting, Risk minimization and management etc.. The class is a mixture of lecture and break-out team exercises designed to challenge the participants in the various roles and responsibilities of a Pharmacovigilance expert or Clinical Safety specialist . This class also covers the basic functionality of Safety databases and consists of presentations, lectures and Hands -on Exercises. Each participant will be allowed and connected to live safety databases.

FUNCTIONALITY COVERED...

• • Fundamentals in Clinical Research
• • Basic Epidemiological Principles
• • Different Methods of Pharmacovigilance
• • Spontaneous ADR reporting, terminologies used in Adverse reaction Monitoring
• • Causality assessment of adverse drug reactions and severity, seriousness, preventability criteria by using different scales.
• • Indian pharmacovigilance System.
• • National Pharmacovigilance Program (NPVP)
• • Pharmacovigilance industry, its regulatory obligations and periodic safety update reports (PSURs)
• •Risk Minimization & Risk Management Program.

LEARN HOW TO........

Interrogate Safety databases using advanced condition searches

Set up aggregate and periodic reports

Create and Track submission of expedited reports

Perform Dashboard reviews that can be used for monitoring and analysis

Import and export E2B reports.

WHO SHOULD ATTEND?

Medical Doctors and Pharmacy graduates.

COURSE TITLE : DIPLOMA PROGRAM IN MEDICAL CODING

COURSE DURATION : 1 Month

COURSE GLOBAL CODE : DDCP04MC

This class designed to provide a basic understanding of the scope, structure, characteristics of MedDRA and the relevant regulations concerning its use.

FUNCTIONALITY COVERED...

What is new in MedDRA Terminology?

• • Overview of MedDRA development
• • MedDRA's scope, structure and overview
• • MedDRA Maintenance
• • Regulatory considerations
• • Coding with MedDRA: Introduction to MedDRA Term Selection: Points to Consider document
• • Introduction to MedDRA Data Retrieval and Presentation: Points to Consider document
• • Coding examples
• • Introduction to Standardised MedDRA Queries

COURSE TITLE : DIPLOMA PROGRAM IN MEDICAL WRITING (MW)

COURSE DURATION : 2.5 Months

COURSE GLOBAL CODE : DDP05MW

ABOUT THE CLASS:

High-quality medical writing, which has a multi-million dollar impact on a company’s financial performance, can prevent the need for additional clinical trials which are often required because of unclear communication and poorly written documents. Good medical writing can lead to optimal product labelling, allowing successful product promotions and maximization of advertising claims.

LEARNING OBJECTIVES:

• • What medical writing encompasses
• • How to write documents that meet the company’s goals and objectives
• • Why publishing is an essential part of therapeutic product position
• • How to write an abstract or manuscript
• • How to control sentence structures for precise delivery of data.
• • Understand the mandates for documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
• • Know how the reporting process supports products in research, development, and the marketplace
• • Understand the importance and underlying principles of the FDA regulatory review process for chemical drugs, biologics and biopharmaceuticals from Phase 1 IND through market approval

WHO SHOULD ATTEND?

Personnel in the pharmaceutical, biopharmaceutical, biologics and generic drug industry who are involved in preparing FDA submissions (INDs, NDAs, BLAs, ANDAs, and post-approval supplements) will find this course to be of particular benefit.

COURSE TITLE : DIPLOMA PROGRAM IN REGULATORY AFFAIRS

COURSE DURATION : 2.5Months

COURSE GLOBAL CODE : DDP06RA

ABOUT THE CLASS:

The Regulatory Affairs function within the pharmaceutical industry is absolutely pivotal to the successful development and licensing of safe and effective medicines, to the benefit of patients’ health worldwide. A winning combination of lectures and interactive case studies that afford you the opportunity to put theory into practice. This Residential course providing plenty of time for exchanging knowledge and sharing experiences with fellow students and speakers.

LEARNING OBJECTIVES:

• • Discover the origins and purposes of pharmaceutical regulation, and the principle regulatory bodies. Appreciate how they affect your role as a regulatory affairs professional
• • Introduction and EU Overview.
• • US and International Regulatory overview.
• • Know how to ensure your pre-clinical and clinical studies comply with both key EU and US regulations, including GLP, GCP, the EU Clinical Trials Directive and FDA requirements
• • Learn the fundamental procedures, issues and initiatives (including the FDA Critical Path) that will have an impact on your regulatory strategy
• • Gain awareness of other procedures so you can manage the approval process for a range of product types (including biosimilars, generics and variations)
• • Find the approach to gaining marketing authorisation that works for your markets – and make sure you meet the required safety standards.
• • Keep abreast of current standards and relevant issues (such as regulation of orphan drugs and problems surrounding parallel trade) and prepare for changes, to ensure continued compliance across your company.

WHO SHOULD ATTEND?

People new to Regulatory Affairs who want to acquire a comprehensive foundation Regulatory Professionals wishing to update their knowledge Allied Professionals wishing to understand the role of Regulatory Affairs