COURSES WE TEACH

PHARMACOVIGILANCE

  •  Introduction to Pharmacovigilance (PV) Course curriculum.
  •  PV Career scope & PV Companies in India.
  •  Introduction to Pharmacovigilance (PV) Basics.
  •  PV Terminologies & Glossary.
  •  PV Websites.
  •  MedDRA Coding.
  • ICH Guidelines (E2A to E2F).
  •  GVP Modules (1 to 16 Modules).
  •  Causality Assessment.
  •  Safety Narrative Writing (3 Types of Narratives, Spontaneous, Clinical Trial & Literature).
  •  Training on PV Database, PV Work Flows & Different software’s in PV Industry.
  •  Vaccine Pharmacovigilance.
  •  Materiovigilance (Medical Device).

MEDICAL WRITING

  • Introduction to Medical Writing.
  •  Clinical Trial Terminologies and Definitions.

Clinical:

  •  Clinical Trial Protocol.
  •  Clinical Study Reports.
  •  Informed Consent Form, Case Record Form.

Regulatory/Labelling:

  •  Preparation of PIL/PI/SmPC.
  •  Clinical and Nonclinical Overviews and Summaries.
  •  Justification document, Addendum, Bio-waiver Justification.
  •  Core Data Sheet/ Core Safety Information.

Publication:

  •  Journal/Abstract.
  •  White Paper Presentation.

Medico-Marketing:

  •  Continuous Medical Education, Physician Desk Reference.

COMPUTERIZED SYSTEM VALIDATION

Detailed understanding on US FDA and EMEA requirements for Computer System Validation, Electronic signatures, Part 11 compliance and signatures.

GAMP 5 Classification:

Simplified! – Risk Management approach and principles for Part 11 compliance.

Audit Trials:

Demonstrating Data Integrity via Documentation and Audit Trails

Backup:

Backup and Restoration procedures in detail.

Regulatory Requirements:

In depth guidance on translating the regulatory authorities expectations and communicating with them effectively through interactive sessions.

Take Back to Your Job:

Interpret the 21 CFR Part 11 regulation.

Understand Part 11 key issues and be prepared for Part 11 inspections.

Apply GAMP risk management approach for Part 11 compliance.

Discuss international regulatory expectations for use and control of electronic records and signatures in computer systems used in the pharmaceutical and related life sciences industries.

Workshop series featuring half day sessions on.

Documentation for demonstrating.

Data Integrity.

Audit Trails.

Vendor Assessment & Qualification.

Writing a URS.

Backup procedures.

Validate your systems to ensure accuracy, reliability, consistent performance and data integrity.

Total 20 hrs. (+ 5 hrs. post-training queries support over TC

ARGUS SAFETY FOR ADMINISTRATORS

Course Introduction and High-level Overview of Argus Safety :

Module – 1: Argus Safety Configuration

Codelist configuration :

Argus Console overview.

Codelist configuration.

Flexible Data Re-categorization configuration.

Business configuration :

Business configuration overview.

Company products configuration.

Regulatory reporting rules configuration.

Studies configuration.

Access management :

Access management overview.

Users configuration.

Sites configuration.

Group configuration.

System configuration :

System Configuration overview.

Case priority setup.

Field validations configuration.

Field properties.

Argus system case numbering setup.

System Management.

Workflow configuration.

SMTP configuration and it’s uses.

Module – 2: Argus Safety Technical Aspects:

Argus Safety Architectural Overview and Details :

Argus Safety Web Server.

Argus Safety Services.

Argus Interchange overview.

Axway (E2B) Gateway overview.

Argus Safety Troubleshooting Tips :

AG Service Configuration and Logs.

ESM Service Configuration and Logs.

SQL TIMES.

Error Log.

CLINICAL DATA MANAGEMENT

Module – 1: Introduction to Clinical Research and Clinical Data Management

Roles & Responsibilities of Key Stakeholders.

Standard Operating Procedures.

Study Set-up Phase :

Module – 2: Creation of Study set-up documents

Protocol Orientation.

Preparation of DMP/DHP.

CRF Design.

Preparation of DVP.

CRF Annotation.

DB-Design and Set-up.

User acceptance test.

Third party data specifications and testing.

Coding Specifications and testing.

SAE Reconciliation specifications.

Self Evident Correction specifications.

Custom reports specifications.

Study Conduct phase :

Module – 3: Study Ongoing phaset

Tracking CRF Data.

Data Entry, Remote Data Entry.

Data review and query management.

Managing Lab Data.

Medical Coding.

SAE Reconciliation.

Post-Production Change management (PPC).

Self Evident Correction Management (SEC).

Creating Reports .

Study Close-out phase :

Module – 4: Study Close out phase

DB listings QC as per QC plan.

Track all data as per DB Lock checklist.

Final DB QC.

Data Base Lock.

Data Base archival and study data transfer.

Module – 5: Case Studies

CLINICAL RESEARCH

Introduction to CR – 2 hrs

a) Definitions and types of CR.
b) Overview of CR processes.
c) Opportunities in CR.
d) Career Development in CR.

BA/BE studies-Clinical and Regulatory procedures-ANDA-21 CFR 320 – 4 hrs.

CRO-Organization, Structure, Role, Responsibilities, Costing – 4 hrs.

Contracts and Agreements—CDA, MSA, CTA – 2 hrs.

Insurance and Indemnity – 1 hr.

Overview of SOPs/Study Plans – 2 hrs

Overview of Protocol, ICF, IB, AEs – 3 hrs

Responsibilities: Sponsor/Investigator/EC – 4 hrs

Phases of Clinical Trials – 2 hrs

Clinical Trial Management-ICH GCP – 4 hrs

 

Clinical Trial Procedures:

Budgeting, Medical Writing, IM, SIV, SMV, SCV – 4 hrs.

CT-Regulatory- Indian Forms as per CDSCO-# 44, 45, 12, 11 – 2 hrs

US-Forms-1571, 1572, 3454, 3455 – 2 hrs

CT-Regulatory Procedures-India-Schedule Y – 4 hrs

US-21 CFR part 50, 54, 56, 312, 314 – 4 hrs

EU-EMEA, Australia-TGA, UK-MHRA, Canada-HPFB, Japan – 4 hrs

All CR related Forms-AE, SAE, Subject ID code list, Staff Delegation log, etc – 4 hrs

Audits and Inspections: Overview-Quality systems and SOPs – 2 hrs

Audits and Inspections: Overview-Quality systems and SOPs – 4 hrs

Medical Devices-PMA, similarities and differences between Medical Devices and Drugs – 2 hrs

SAS and Clinical Trails Training Course

Introduction to SAS

  • What Is SAS?
  • About SAS?
  • Where SAS?
  • Why SAS?
  • Scope of SAS Software
  • Overview of Base SAS Software
  • Data Management Facility
  • Structure Of SAS Dataset
  • SAS data file
  • SAS data view
  • SAS Language Elements
  • DATA step
  • PROC step
  • Different Types of SAS Sessions
  • SAS Windowing Environment
  • Interactive Line Mode
  • Noninteractive Mode
  • Batch Mode
  • Rules for SAS Program
  • Rules for SAS Dataset Names
  • Rules for SAS Variable Names
  • Data Types
  • Variable Types
  • What Missing Data?
  • What is Comment and how many ways of comments?
  • Expressions
  • Arithmetic Expressions (Operators)
  • Comparison Expressions (Operators)
  • Logical Expressions (Operators)

About PDV and SAS Library

  • What is PDV (Program Data Vector) and how it will work?
  • What is Compilation Phase?
  • What is Execution Phase?
  • What is Library?
  • Types of SAS Libraries
  • Default Libraries(System Defined)
  • Temporary Libraries (System Defined)
  • Permanent Library (User Defined)
  • Temporary Library (User Defined)
  • Creating Libraries using GUI

Reading Raw Data intoSAS

  • What Is Raw Data
  • Definitions
  • Data Values
  • Numeric Value
  • Character Value
  • Standard Data
  • Nonstandard Data
  • Numeric Data
  • Character Data
  • Raw Data Types
  • Internal Data
  • External Data (or) External File
  • Reading Raw Data with INPUT Statement and Features
  • List input
  • Column Input
  • Formatted Input
  • Mixed input
  • Named input
  • Reading Data From External Files
  • Reading Blank Separated Values (List Or Free Form Data)
  • Reading Raw Data Separated By Commas (.Csv Files)
  • Reading In Raw Data Separated By Tabs (.Txt Files)
  • colon (:) modifier
  • Ampersand (&) modifier
  • The column pointers
  • @ (At the rate)
  • + (Plus)
  • Line holder
  • @ (Single Trailing )
  • +@@ (Double Trailing )
  • Line pointers
  • / (Slash)
  • # (Pouns)

SAS Options

  • What is SAS Options?
  • SAS Option Types
  • System Options or Global Options
  • Data Set Options
  • Proc Options
  • Infile Options

SAS Informat

  • Overview
  • What is Informat?
  • Types of Informat
  • Character Informat
  • Numeric Informat
  • Date/Time Informat
  • User Define Informat
  • Character Informat
  • Numeric Informat
  • Different ways of using Informat
  • Input statement
  • Input Function
  • Informat Statement
  • Attrib Statement

SAS Format

  • Overview
  • What is Format?
  • Types of Format
  • Character format
  • Numeric format
  • Date/Time format
  • User Define format
  • Character format
  • Numeric format
  • Different ways of using format
  • Put Statement
  • Put Function
  • Format Statement
  • Attrib Statement
  • %sysfunc macro

SAS Functions

  • Overview
  • Using Functions
  • Categories Of Functions
  • Character Functions
  • Numeric Functions
  • Date/Time Functions
  • Macro Functions

SASStatements

  • Overview
  • Using statements
  • Types of statements
  • Action
  • Control
  • File – handling
  • Information

SAS Automatic Variables

  • Overview
  • Use of Automatic Variables
  • _N_
  • _ERROR_
  • _CHARACTER_
  • _NUMERIC_
  • _TYPE_
  • _LABEL_
  • First dot
  • Last dot

SAS Procedures

  • Introduction
  • The Anatomy of aProc step
  • Types of statements
  • Utility procedures
  • Statistic procedures
  • Reporting procedures

Output Delivery System (ODS)

  • Introduction
  • Creating Various Types Of Reports Listing Output
  • Other Destinations
  • Html
  • PDF
  • Rtf Files
  • Microsoft Excel
  • Adding Style To Your Reports
  • Locate Existing Styles

ProcSql

  • Introduction
  • Why Learn ProcSql?
  • Select Statement
  • The Select Statement Syntax
  • A Simple ProcSql
  • A Complex ProcSql
  • Limiting Information On The Select
  • Creating New Variables
  • The Calculated Option On The Select
  • Using Labels And Formats
  • The Case Expression On The Select
  • Additional Select Statement Clauses
  • Sorting The Data In ProcSql
  • Sort On New Column
  • Subsetting Using The Where
  • Selection On Group Column
  • Use Having Clause
  • Creating New Tables
  • Joining Datasets Using ProcSql
  • Inner Join
  • Joining Three Or More Tables
  • Outer Joins

SAS Macros

  • Introduction
  • SAS Macro Overview
  • Traditional SAS Programming
  • The SAS Macro Language
  • Macro Language Components
  • Macro Variables
  • Macro Statements
  • Macro Processor Flow
  • Automatic Macro Variables
  • Macro Debugging Options
  • What Is A Macro?
  • Defining And Using Macros
  • Passing Parameters
  • Positional Macro Parameters
  • Keyword Macro Parameters
  • Conditional Macro Compilation
  • Indirect referencing
  • Macro libraries
  • Compiled stored macro library
  • Auto called library

Clinical Topics

  • SAS role in Clinical Research
  • What is Clinical Research
  • What is Protocol and role of Protocol in Clinical Research?
  • What is randomization and non-randomization?
  • What is CDM (Clinical Data Management)?
  • What is SAP (Statistical Analysis Plan)?
  • Role of SAP in Clinical Research
  • SAS Work Flow in Clinical Research
  • Drug Development Process
  • Different phases in Clinical trails
  • Pre-Clinical trails
  • Phase I
  • Phase II
  • Phase III
  • Phase IV (Post marketing Trail)
  • Study Designs
  • Randomized
  • Blind
  • Single blinding
  • Double Blinding
  • Triple Blinding
  • Placebo-controlled
  • Different types of designs
  • Parallel Group Study
  • crossover study
  • Annotated CRF
  • SAP (Statistical Analysis Plan)
  • CDISC and Data Standards
  • SDTM (Standard data model)
  • ADM (Analysis Data model )
  • ODM (Operational Data Model)

 

Live  Project

  • Development of ADS (Analysis Data sets) from raw data
  • Development of TFL(Table, Figure and Listing) using ADS (Analysis Data sets)

Pharmacovigilance Course-Advanced

PADERs : 
1. PADER calendar  preparation.
2. Timelines and submission procedures
3. Drafting of pader  as per the temple.
4. Line listing generation.
PSURs/PBRERs:
1. Calendar preparation
2. Stakeholder communication procedures
3. Timelines and submission procedures
4. Drafting of PSUR and PBRER
5. Line listing generation
Risk Management plan:
1. What is  RMP and regulatory requirements
2. Timeline and submission procedures
3. Drafting of RMP as per the EU guidelines.
4.  Revision of RMPs
Signal Management:
1. What is  signal and regulatory requirements.
2. Signal calendar preparation
3. Line listing review
4. Signal detection process
5. Drafting signal detection reports as per EU requirements.

Drug Safety Physician Course Pharmacovigilance

1. Medical review of ICSRs-
  •  Medical review comments
  •  Relatedness assessment
  •  Listednes
  •  MedDRA coding
  •  Seriousness assessment IME and DME list
2. Special scenarios cases codings and assessment
3. Line listings review
4. Literature articles review and assessment
5. Medical inquires response
6. Dechallenge and dechallenge assessment.
7. Medical review of PADERs and literature assessment.
8. Medical review of PSURs/ PBRERsand literature review and assessment.
9. Medical review of signal management and literature review and assessment
10. Medical review of risk management and minimisation.

Argus Safety for Administrators

Module – 1: Pharmacovigilance

Pharmacovigilance overview
Argus Safety Overview

Module 2: Codelist configuration

Argus Console overview
Codelist configuration
Flexible Data Re-categorization configuration
·
Module –3: Business configuration

Business configuation overview
Company products configuration and best practices
Regulatory reporting rules configuration and best practices Studies configuration
·
Module –4: Access management

Access management overview
Users configuration
Sites configuration
Group configuration
Access management best practices

Module 5: System configuration

System Configuration overview
Case priority setup
Field validations configuration Field properties
Argus system case numbering setup
System Management
Workflow configuration and best practices
SMTP configuration and it’s uses
·
Module –6: Argus Standard modules

Argus Safety Services
Argus Interchange overview
E2B Gateway overview

Module –7: Assessment

Course completion certification

Understanding E2B R2 Reports

Module- 1: E2B Introduction

What is E2B?
E2B R2 Structure
Mapping of E2B elements with ICSR data

Module -2: E2B Profile

E2B Profile Introduction
E2B Profile Definition

Module -3: Setting Up Agency for E2B Transmission in Argus Safety

Introduction to ESM Module
E2B Profile configuration
Agency set up
Data flow of ICSR (E2B) report to Agency/Partner

Module –4 : E2B Validations

What are E2B Validations?
E2B Validation set up

Module –5: Assessment

Assessment
Course completion certification

Argus Safety Database Essentials

Pre-req :

Prior knowledge of SQL/PL-SQL

Module -1: Pharmacovigilance

Pharmacovigilance overview
Argus Safety Overview

Module –2: Argus Safety database overview

Argus Safety database structure
Code list tables
Configuration tables
Case Data tables

Expedited Reporting Tables
Periodic Reporting Tables

Module –3: Case Study and Hands On Exercise

Case Study
Hands On Exercise

Assessment
Course Completion Certificate

Argus Safety Database Essentials

Pre-req :

Prior knowledge of SQL/PL-SQL

Module -1: Pharmacovigilance

Pharmacovigilance overview
Argus Safety Overview

Module –2: Argus Safety database overview

Argus Safety database structure
Code list tables
Configuration tables
Case Data tables

Expedited Reporting Tables
Periodic Reporting Tables

Module –3: Case Study and Hands On Exercise

Case Study
Hands On Exercise

Assessment
Course Completion Certificate

eTMF Module

1. Introduction to Essential Documents
2. Introduction DIA eTMF reference model
3. eTMF Mangement Plan
4. eTMF tools description
5. eTMF EDL creation
6. eTMF conduct
7. eTMF review
8. eTMF reconcilliation
9. eTMF document upload
10. eTMF document completion guidelines
11. eTMF demo -Viva Vault
12. eTMF demo – general systems
13. eTMF filling guidelines
14. Assessments -1
15. Mock Interview Questions

15 hours Classroom/Online Training

CTD/eCTD Regulatory Affairs Basics

1. 1. Introduction to RA profession
Regulatory Affairs Profession, role and its importance, overview of

worldwide Regulatory agencies

General Overview of the Pharmaceutical Industry, its functioning, role of various Departments
like R & D, Production, RA, QA, Project Management, Supply chain etc. Within the industry

2. ICH and CTD
Overview of ICH
Introduction and overview of CTD

3. Organization of CTD
Module 1. Administrative and Prescribing Information

(Region specific)

Module 2. Common Technical Document Summaries
Module 3: “QUALITY” – CMC section of the CTD
Module 4: Nonclinical study reports
Module 5: Clinical study reports

4. Introduction to eCTD

Need to Harmonize
Origin of CTD
CTD Modules
Introduction to eCTD
Document Granularity
Advantages of eCTD
Need of eCTD Builder Software
DTD
Index.xml File
Regional xml File
USFDA

 Admin Information in US-regional.xml
 File Formats supported in eCTD for USFDA
 PDF Specification for USFDA

Folder Structure
STF (Study Tagging File)
RSN Concept
Way to submit the Final Submission
Things to be taken care while preparing eCTD submission

15 hours Classroom/Online Training

CTD/eCTD Regulatory Affairs Advanced

Chapter Topic 1

Introduction to RA profession

  • Regulatory Affairs Profession, role and its importance, overview of  Worldwide Regulatory agencies.
  • General Overview of the Pharmaceutical Industry, its functioning, role of various departments like R & D, Production, RA, QA, Project Management, Supply chain, etc. within the industry

2. Overview of Drug Development Process

  • New Drug Approval and Development
  • Preclinical Investigation
  • Investigational New Drug Application (INDA)
  • Clinical Investigation
  • New Drug Application (NDA)
  • Phase IV (Post marketing Surveillance)
  • Importance of Pharmacovigilance,
  • EVMPD and XEVMPD

 

3. Formulation or Product development

  •  Basic formulation development and manufacturing
  • Importance of preformulation studies and planning
  • PDR writing as per ICH Q8

4. GMP , GLP and GCP

  • Overview of GMP
  • Overview of GLP
  • Overview of GCP
  • ICH GCP Guidance’s and its importance
  • ICH E3, ICH E6
  • Importance of PIC/S

5. Regulatory System in US (FDA)

  • History of FDA and Related Regulatory Agencies
  • FDA & CDER – Organization and responsibilities
  • Types of Drug applications in US [IND, NDA, ANDA, 505 (b)(2)]
  • Investigational New Drug Application: INDA
  • New Drug Application: NDA
  • Generic Drug Submissions
  • ANDA submission in detail
  • Bioequivalence Recommendation for Specific Products
  • Establishment registration, drug registration and National Drug Code Directory (NDC)
  • Changes to an approved ANDA and annual reporting
  • Over-the-Counter Drug Products
  • Regulation of OTC Drugs
  • Rx-to-OTC Switch
  • Patents and Exclusivity
  • Prescription Drug Labeling, Advertising and Promotion
  • Labeling Regulations and Requirements
  • Structured Product Labeling (SPL)

6. Biologics Submissions

  •  IND Process for Biologics
  • Preclinical Development Considerations for Biologics
  • Clinical Development Considerations for Biologics
  • Manufacturing of Clinical Trial Material for Biologics
  • BLA Format and Content
  • BLA Review Process
  • Biosimilars
  • Vaccines and Related Biological Products

7. Drug Substance Registration Drug Master Files (DMF)

  • Type I —Reserved, no longer applicable
  •  Type II — Drug substance, drug substance intermediate and material used in their preparation, or drug product
  •  Type III — Packaging material
  •  Type IV — Excipients, colorant, flavor, essence or material used in their preparation
  •  Type V — FDA accepted reference material
  • COS/CEP
  • ASF

8. Life Cycle of Drug Product

  • Prior Approval Supplement (PAS)
  • Post Approval Changes [SUPAC]
  • Changes Being Effected in 30 Days (CBE-30)
  • Annual Report
  • Post marketing Reporting Requirements
  • Post approval Labeling Changes
  • Lifecycle Management
  • FDA Inspection and Enforcement Act
  • Form FDA 483
  • Establishment Inspection Report (EIR)
  • Warning Letters
  • Recalls, Seizure and Injunctions

9. Regulatory System in Canada (Health Canada)

  • New Drug Approval Process
  • Generic Drug Approval Process

10. Regulatory System in Europe (EMA)

  •  Pharmaceuticals in the European Union
  • History of Drug Regulation in European Countries
  • Centralized Regulatory Authority of European Union (EU)
  • EUDRALEX: EU Pharmaceutical Legislation
  • European Medicines Agency (EMA)
  • Regulation of medicines in the European Union
  • Marketing Authorization
  • Centralized Procedure (CP)
  •  Mutual Recognition Procedure (MRP)
  •  Decentralized Procedure (DCP)
  •  National Procedure
  • Types of Variations

11. Drug Registration with Rest of the World (ROW)

  • Introduction and Overview of Row regions and sub-regions
  • Registration with South-East Asian countries (ASEAN)
  • Registration with Latin America (Brazil, Mexico),
  • Registration with Middle East countries (GCC)
  • Registration in Emerging market (India, Russia, China, Japan, South Africa)

12. Dossier Preparation-Different Formats used Globally-

  •  pCTD [Paper- CTD]
  • eCTD [Electronic CTD]
  • ACTD [ASEAN CTD]
  • NeeS [Non eCTD Electronic Submission]

13. Dossier preparation in pCTD and eCTD format

  1.  Introduction and Overview
  2. CTD Format for Each Submission (US/EU)
  3. Module 1 – Administrative and Prescribing Information
  4.  Module 2 – Common Technical Document Summaries
  5. Module 3 – Quality Part-CMC
  6.  Module 4 – Nonclinical Study Reports
  7.  Module 5 – Clinical Study Reports
  8. Electronic Submission
  9. Planning your electronic submission
  10. Regulatory requirements
  11. Tool and Technologies Electronic Submission Process
  12. NeeS: Non eCTD electronic Submission
  13. · eCTD: Electronic submissions with xml backbone files
  14.  Electronic Submission Gateway (ESG)

14. Dossier preparation in ACTD format

  • Introduction and Overview
  •  ACTD Format for ASEAN countries
  •  PART-I – Administrative and Prescribing Information
  •  PART-II – Quality Part-CMC
  • PAR-III – Nonclinical Study Reports
  • PART-IV – Clinical Study Reports

15. ICH Quality Guidance’s and its importance

  • Overview of –
  • ICH Q1 – Stability studies
  • ICH Q2 – Analytical Method Validation
    • ICH Q3 – Impurities
    • ICH Q4 – Pharmacopoeias
  • ICH Q5 – Quality of Biotechnological Products
    • ICH Q6 – Specifications
  • ICH Q7 – Good Manufacturing Practice
  • ICH Q8 – Pharmaceutical Development
  • ICH Q9 – Quality Risk Management
  • ICH Q10 – Pharmaceutical Quality system
  • ICH Q11 – Development and Manufacture of Drug Substances(QbD)

16. 21CFR Part 11 guidance and its importance

17. Abbreviations

15 hours Classroom/Online Training

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