Post Graduate Diploma In Clinical Research

INTRODUCTION Clinical research documentation is a continually expanding industry because of growing biotechnology. Salaries are paid based on ones qualification and also on their background and education. The job profile could be that of a data coordinator, clinical data reviewer, medical communications consultant, drug safety specialist, or clinical research coordinator depending on your qualification and experience.

Course Goals:
The course participants will become familiar with clinical research functions. The course gives an overview of how clinical research can be implemented. It explains how clinical research can be implemented quickly and efficiently in a company

Eligibility Criteria:
Professionals like MBBS / [Link] / [Link]/Msc science students Bio-life Employees of Bioinformatics / Pharmacuetical/Medicine industry

Note:
This course gives you an overview of clinical research. You will learn about the functions of clinical research and the solution with the help of simple examples. In particular, the aim of the course is to demonstrate implementation scenarios for your company so you can organize your project planning accordingly. The course is a necessary requirement for the following detail courses for Clinical Research.

Course Content:
Designing of Clinical Trials Investigators and sites Statistical Elements Trial subjects Selection of investigators and sites, visits, initiation and close out. Sample size, randomization, coding Recruitments, withdrawal drops out Definitions and Concepts Selection of volunteers, planning and design of studies Inclusion/exclusion criteria, sampling and analysis QA & QC, responsibilities of staff, drug accountability Definitions and Concepts, DSMBs SAE, safety, Guidelines, Methods, Forms WHODD, MEDDRA, COSTART, WHOART, ICDG Post Marketing studies, PSUR, package inserts Project managements, objectives, task network Resource and supplies, drug supplies, distribution Budgeting, Costing, Over Runs, Insurance Misconduct and fraud, detection and management Objectives, Procedures, Reporting

Pharmacokinetics & Drug Interactions

Overview Pharmacokinetics Study conduct Quality and Responsibility Drug Safety & Pharmacovigilance Overview Pharmacovigilance Medical Coding Managements of Clinical Trails Drug Safety Overview Project Resource Finances Non Compliance Trial monitoring

(Over View in Relation to CDM)

Post Graduate Diploma In Clinical Data Management

INTRODUCTION
Strong knowledge of SAS software, familiarity with system development processes and general computing as relates to pharmaceutical development. The data management and database design principles and exposure to requirements for statistical computation regarding layout and presentation of data which exposure to principles of computer validation, testing, and system integration concepts.

Course Goals: Apply project management concept to your work and implement strategies for effective CRO management Recognize the rationale for FDA standardization & recognize what impact it has on daily work Describe medical coding practices to your projects Apply better Eligibility Criteria: Life Science (Microbiology, Genetics, Biotechnology, Zoology, Chemistry, Botany, Biochemistry), [Link]/[Link] MPharm, MBBS, BDS, BAMS, BHMS, Pharma & Clinical Research Professionals, IT or Statistics background. BPharm, Note: The Manager of Clinical Data Management manages CDM activities to ensure the successful completion of projects and
achievement of departmental goals. This includes:

technical guidance to the data management staff. Providing responsibilities and supervising employee development. Prioritizing as a primary resource and point of contact for departmental staff, project managers, line managers, executive staff and Serving
clients.

Course Content: Trial Process Clinical Trial Design Clinical Good Clinical Practice Ethics & Data Management Clinical CRF Design Data Entry Data Collection Data Load Data Storage Data Validation Query Management Data Archiving Systems, Sops & Audits Quality Affairs & Compliance Regulatory Safety Management and Pharmacovigilance Analysis & Reporting Statistical Data Management Systems & Tools CDMS

AERS EDC Tools Analytical Documentation & Document Management System coding and medical dictionaries Medical Management Project systems Security
Practical Data Management System (ORACLE Clinical) Clinical Study Set-Up Creation Database CRF Creation Data Entry Data Validations Query Management lock Database Software + SAS Statistical

Post Graduate Diploma in Clinical Research Specialization in Business Development

INTRODUCTION
We have access to outstanding infrastructure for conducting clinical trials and provide clinical trial strategies tailored for product research and development for pharmaceutical, biotechnology and medical device companies. Clinical Trials Business Development Centre can connect you with the study of Design & management, Data management and analysis and Regulatory affairs and services.

Course Goals: Study planning and Implementation research form (CRF) preparation Clinical Data Management and Analysis Affairs Services Regulatory Eligibility Criteria: [Link]/[Link]/MBBS PG-MBA/PGDM- International Business, Marketing. Note: of SAS data for FDA/EMEA/TGA Preparation Study monitoring and data collection report writing Medical affairs submission compliance service Regulatory Course Content:

Clinical Research
Drug Design and Discovery and Ethical requirements Regulatory and Clinical Studies Pre-Clinical Good Clinical Practice Assurance Quality Pharmacovigilance and PSUR Data Management Clinical study report and Medical Writing Clinical Outsourcing Clinical Trial and Clinical Trial Supplies

Management
Management Service Relationship Management Customer Sales Management & Budgeting Costing Management Marketing Interpersonal Skills Communication Business Introduction to Database Management Introduction to e- Commerce & e- Communications

Post Graduate Diploma in Clinical Research Specialization in Quality Assurance and Audit
INTRODUCTION
Clinical Quality Assurance & Audit includes planning, scheduling, conducting, reporting & evaluation of quality level & compliance with applicable GCP regulations & standards for Clinical Quality Assurance unit & client groups. Understanding of GCP regulations & standards for interpretation of audit findings, impact & implications, Develop written procedures & SOPs for Clinical QA unit, assess quality systems/scientific reports & clinical data.

Course Goal: the management of quality systems for all systems and software products used by Perceptive operating units and Directs
support functions.

direction internally regarding Quality Systems, regulatory compliance, computer system validation, and good Provides
engineering practices.

direction for the maintenance and continuous improvement of the Corporate Quality System and Standard Operating Provides
Procedures.

all audit functions: Internal, Client, Regulatory, and Supplier. May act as the audit host for all regulatory inspections Oversees
world-wide.

Eligible Criteria: UG [Link]/B.E. Bio-Chemistry/Bio-Technology, Biomedical PG [Link] Bio-Chemistry/Bio-Technology, Biomedical Note: manage and coordinate the development and maintenance of a Quality System in accordance with ICH guidelines Direct, manages the process of hosting of customer audits and oversees audit follow-up and action plans, as Direct and
appropriate.

the internal audit program. Schedule work assignments, including ongoing assessment of staffing needs for current Oversee
and potential audits.

Course Content: ICH-GCP Introduction to GMP/GLP ISO Six Sigma Operating Procedures Standard Assurance Quality Trial Audit Systems Audit ( Including 21CRF Part 11) Software Pharmacovigilance Auditing Research Clinical

Post Graduate Diploma in Regulatory Affairs

INTRODUCTION
Regulatory affairs can be defined as a section of government which deals with the safety of public health by controlling the quality & efficacy of different products like pharmaceuticals, medical devices, agrochemicals etc. If the data is found satisfactory; then only the pharmaceutical company gets the approval to proceed to next step of product Development. It analyses the each & every data obtained during the Development of the compound, its processing, the trials, marketing. Course Goals:

of society safety rules & regulations for the companies setting production & marketing of QUALITY PRODUCT protection human rights & ethics
Note: 4 Learn how to register your biotech product successfully

Eligibility Criteria:

[Link]/[Link] Life Science/Nursing, [Link], [Link],

MBBS, BDS BAMS,BHMS

& Clinical Research Professionals Pharma

4 Know whether data generated is adequate for your dossier submission 4the manufacturing process for biotech products Clarify 4complete view of developing a biotech product Gain a 4the regulatory requirements when submitting your applications Clarify 4 the risks associated with biotech products at each stage of the process Identify Course Content: 4 INTRODUCTION

of clinical research Basics Meaning of regulatory affairs Requirement of regulatory affairs in clinical research
4 & OVERVIE HISTORY ROLE OF 4 REGULATORY BODIES IN

Thalidomide tragedy Sulphanilamide tragedy Tuskegee trial Federal food, drug & cosmetics act
4 REGULATORY PERSONNELS IN A PHARMACEUTIC COMPANY

development & processing Drug trials Clinical Marketing marketing Post regulatory practices (GRP) Good Auditing
DOCUMENTS & APPLICATIONS 4 IND - NDA - DMF - BLA - OTC - DOSSIER - ANDA CFR & ITS ROLE IN REGULATORY AFFAIRS 4 DECLARATION OF HELSINKI 4

Eligibility Functions & responsibility Roles

4 REGULATORY BODIES IN DIFFERENT COUNTRIES

US (FDA) (DCGI, DCSO, ICMR) INDIA EUROPE (EMEA)

Belmonte Report The Nuremberg Code The