Subtotal:
₹1,000.00
Introduction to Pharmaceutical Science
- Introduction to Pharmaceutical Labelling
- Introduction to GMP in Pharma Industry
- Introduction to European Medicines Regulation - Free
- Introduction to Regulatory Affairs
- Introduction to Pharmacovigilance
- Introduction to Quality Management System
- Introduction to Medical Devices
- Introduction to Clinical Trials
- Introduction to Medical Writing
- Introduction to Medical Coding
- Introduction to Clinical Data Management
Regulatory Affairs
Pharmacovigilance
Medical Coding
Computer Aided Drug Design (CADD)
Computerized System Validation (CSV)
About Courses
This course provides a brief introduction to the various branches of pharmaceutical sciences and the scope of work available in the industry. It is designed to be beneficial for both those new to the field and working professionals. This will help learners understand the different types of jobs available, their work, and the latest changes and trends.
The course comprises ten chapters, each focusing on a specific branch of pharmaceutical sciences such as regulatory affairs, medical coding, etc. By the end of this course, learners will be able to identify their areas of interest and expertise in the pharmaceutical industry.
- Duration 2 - 3 Hours
- Language English
- Speaker TBC
- Certification Attendance Certificate
Description
Pharmaceutical labelling is a very important step in packaging and labelling as it helps physicians and pharmacists in improving their compliance with drug handling and therapy. This course is intended to provide you with a thorough overview of the labelling process, general labelling requirements, sets of instructions, and many other norms related to the labelling of pharmaceutical products. In addition, the course will also help you understand cautionary and advisory labels and their need.
Courses Outcomes
Upon the completion of this course, participants would be able to:
● Understand the process of labelling pharmaceutical products.
● Describe and differentiate general, cautionary and advisory labels.
● Understand special dosage instructions, types of labels and their use.
● Understand manufacturer guidelines related to the labelling of pharmaceutical products.
Who Should Attend
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centers.
- Duration 2 - 3 Hours
- Language English
- Speaker TBC
- Certification Attendance Certificate
Description
GMP in Pharma Industry stands for Good Manufacturing Practices, and it is a set of rules, regulations, codes, and guidelines that must be followed during the manufacturing of drug substances and products, medicinal devices, and food products. This course helps you understand the basic guidelines and codes of GMP, general requirements, building, and facilities. In addition, it will also give you an insight into raw material, packaging material, and finished products testing.
Courses Outcomes
Upon the completion of this course, participants would be able to:
● Understand the concept of GMP and manufacturing protocols.
● Describe different processes in manufacturing and handling.
● Describe the important regulations and guidelines associated with Manufacturing and quality control.
Who Should Attend
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
- Duration 2 - 3 Hours
- Language English
- Speaker TBC
- Certification Attendance Certificate
Description
This course provides an introductory overview of the development of healthcare products and regulations across the globe. It will enable you with a basic understanding of the regulatory requirements essential to get marketing approvals for healthcare products. The course also includes an overview of different procedures for granting marketing authorization for medicinal products.
Courses Outcomes
Upon the completion of this course, participants would be able to:
● Describe the origins of the regulatory system.
● Outline the regulatory processes associated with various healthcare products across the globe.
● Identify the regulatory systems and organizations in the UK, US, Europe, Canada, India, Australia, and Japan.
● Understand how medicinal products are regulated across the globe.
Who Should Attend
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, PAs, Administrators, and Support Staff associated with regulatory affairs and other related fields such as medical, manufacturing, marketing, and academic research centers.
- Duration 2 - 3 Hours
- Language English
- Speaker Vaibhavi Dargude
- Certification Attendance Certificate
Description
Pharmacovigilance is an emerging field in the pharma-biotech industry, that focuses on detection, assessment, understanding, and prevention of adverse effects of drugs or any other drug-related problems. This course offers you an insight into pharmacovigilance across the globe. It also helps you understand the regulatory requirements, recent market trends, and the best approaches to ensure drug safety.
Courses Outcomes
Upon the completion of this course, participants would be able to:
● Describe the origins of Pharmacovigilance.
● Understand the concept of pharmacovigilance and its role in drug warning, recalling, and labelling.
● Understand rational and safe use of medicine.
● Understand and describe different types of adverse drug reactions.
● Describe operational activities within drug safety departments.
● Describe the drug safety requirements.
● Understand the role of ICH, FDA, EMEA, MHRA, CDSCO in pharmacovigilance.
● Understand the importance of ICSR, Regulatory reporting, Medical Dictionaries in pharmacovigilance.
Who Should Attend
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
- Duration 2 - 3 Hours
- Language English
- Speaker Amol Sagulale
- Certification Attendance Certificate
Description
This course provides a basic understanding of QMS and how it helps manage a product’s or process’s quality. It will help you understand how documents are structured, processed and the responsibilities required for quality management. This course also allows you to understand the document lifecycle in the quality management system.
Courses Outcomes
Upon the completion of this course, participants would be able to:
● Describe how government regulations and requirements are satisfied to launch the product globally.
● Understand how statistical data can be used to improve process efficiency with reduced quality issues.
Who Should Attend
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
- Duration 2 - 3 Hours
- Language English
- Speaker TBC
- Certification Attendance Certificate
Description
This course offers you a basic understanding of medical devices and their market. It also helps you to understand the lifecycle of medical devices and the regulations involved to meet those demands.
Courses Outcomes
Upon the completion of this course, participants would be able to:
● Understand the concept of medicinal devices.
● Describe the classification of medicinal devices.
● Explain the lifecycle activities of medicinal devices.
Who Should Attend
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
- Duration 2 - 3 Hours
- Language English
- Speaker Vaibhavi Dargude
- Certification Attendance Certificate
Description
This course covers regulatory requirements for conducting clinical trials. It helps you understand and overcome the challenges that arise during the drug development process. This course also helps you understand the importance of Good Clinical Practice (GCP)and the best ways to meet GCP and regulatory expectations to conduct a drug trial.
Courses Outcomes
Upon the completion of this course, participants would be able to:
● Understand the concept and role of clinical trials.
● Describe different phases involved in clinical trials.
● Describe the important regulations and guidelines associated with clinical trials.
Who Should Attend
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
- Duration 2 - 3 Hours
- Language English
- Speaker Rupesh Kanhare
- Certification Attendance Certificate
Description
This course provides an introduction and overview of the career in medical communication across the healthcare system. It also enables you with essential scientific writing documents, such as medical case reports, clinical trial reports, research protocols, and several other regulatory and medico-marketing documents, along with standards of scientific writings concerning the AMA manual of style.
Courses Outcomes
Upon the completion of this course, participants would be able to:
● Approach medical and scientific documents with an appropriate style and structure.
● Define various levels of editing and skills required for writing a scientific document.
● Develop essential skills to discuss ethical issues in medical communication.
Who Should Attend
Candidates who want to build their career as a medical or scientific content writer. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
- Duration 2 - 3 Hours
- Language English
- Speaker Vaibhavi Dargude
- Certification Attendance Certificate
Description
Medical coding is an emerging field of bioinformatics and is transforming healthcare procedures, diagnosis, medical services, and equipment into universal medical alphanumeric codes. This course enables you with an introductory overview of the medical coding industry and provides you with the fundamental knowledge of medical coding, its principles and guidelines required for succeeding in this career. The career is highly in demand across the globe, and thus this introductory course is curated based on the standards decided by the American Health Association.
Courses Outcomes
Upon the completion of this course, participants would be able to:
● Understand the basics of medical terminology, anatomy, and physiology required for medical coding.
● Effectively work in medical coding management.
● Understand how medical law can comply with the ethical standards of the national health organizations.
Who Should Attend
Candidates who want to build their career as a certified medical coder, Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
- Duration 2 - 3 Hours
- Language English
- Speaker TBC
- Certification Attendance Certificate
Description
Clinical Data Management (CDM) is a crucial process in Clinical Research and is accountable for generating high-quality, reliable, and statistically sound data from pharmaceutical and clinical trials. This course provides a detailed overview of concepts and practical methods implied in planning, collecting, storing, and distributing data in clinical research. In addition, the course also describes how global clinical data strategy is prepared including the standardization of case record form (CRF), CRF compiling guidelines, data lifecycle plans, validation specifications, and therapeutic/phase specific information.
Courses Outcomes
Upon the completion of this course, participants would be able to:
● Use Clinical Data Management System (CDMS) to manage data in clinical trials and research.
● Understand essential elements of clinical data management, theoretical knowledge on regulatory guidelines, CDM workflow, and data management plans.
● Understand CDMS activities involving CRF designing, data entry, data collection, AE management, report creation.
● Understand the responsibilities of CDM personnel.
Who Should Attend
Candidates who want to build their career as a CDM professional, Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres, candidates who want to work on full time/ part-time on flexible hours.