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.
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.
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
This course provides a detailed overview of the evaluation of Medicines Regulations in Europe. It also explains why the selling of medicinal products is restricted only to authorized personnel and how pharmaceutical industries are controlled and regulated. This course provides you with a basic understanding of the basic regulatory requirements to obtain marketing approval for healthcare products. It also helps you understand the concepts of patient safety and the efficacy of medicines.
Upon the completion of this course, participants would be able to:
● Describe the evaluation of medicines regulations.
● Outline the regulatory processes associated with various healthcare products in Europe.
● Importance of safety, efficacy, and quality in medical products.
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Life sciences graduates.
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.
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.
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.
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.
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.
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
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.
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.
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
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.
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.
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
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.
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.
Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc./ MBBS/ BDS), Industry peers, Regulatory professionals in pharmaceutical and healthcare sectors, academic research centres.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Copyright PharmaRegTech Private Limited @ 2021.
