Regulatory Affairs Certification Courses
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Our services also include placement assistance with quality assured training for Pharmaceutical regulatory affairs courses for the interested candidates. Our trainer provides knowledge to the aspirants to protect public health by controlling the safety and effectiveness of the pharmaceutical products through Regulatory affairs classes in our institution. We offer the best training with top placement services.
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1. Introduction to regulatory affairs (2).pptx
Regulatory affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development as well as after drug approval and marketing. Regulatory affairs professionals ensure that products contribute to public health by controlling safety and efficacy through compliance with regulations. They provide strategic and technical advice throughout development and registration of products with regulatory agencies. The scope of regulatory affairs includes pharmaceuticals, medical devices, diagnostics, biologics, and other health-related products.
Regulatory affairs in Pharmaceutical Industry
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
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Strategic decision making in pharmacological companies.
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Regulatory affairs professionals ensure that pharmaceutical products comply with regulations throughout the development, manufacturing, and marketing processes. They advise internal departments and collect data to submit to regulatory agencies for approvals. Dossiers containing technical documents are submitted for registration. Modules cover administrative information, quality overview, chemistry and manufacturing controls for drug substances and products, preclinical data, and clinical trial results. Regulatory professionals help companies avoid issues by properly managing records, data, and agency requirements.
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The document provides information about preparing for a career in the pharmaceutical industry. It discusses the pros and cons of working in the industry, some key statistics about the industry, and how the industry is changing and responding to challenges. It provides tips for how to prepare for an interview, improve chances of getting a job, and what skills are needed at different stages of the research and development process. The industry is still profitable but facing pressures to reduce costs through consolidation and outsourcing while demand for new drugs grows.
regulatory requirements of biologicals.pptx
Biologics are complex protein structures derived from living organisms. Their development and regulation involves several key aspects not required for conventional drugs, including additional pre-clinical toxicology and manufacturing studies as well as special programs like orphan drug designation. The IND and BLA processes require comprehensive documentation of quality, safety and efficacy. After approval, biologics face ongoing post-market safety reporting and review of any manufacturing changes to ensure continued patient protection.
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The document describes the Master of Science in Regulatory Science program offered by the University of Maryland School of Pharmacy. The two-year program can be completed part-time and exclusively online, with five courses taken over five semesters. The science-driven program focuses on drug development and regulation, and teaches skills like developing global drug strategies and differentiating regulatory requirements. Graduates will be prepared for regulatory careers in government agencies like the FDA or in the pharmaceutical industry. The program is complemented by the University's Center of Excellence in Regulatory Science and Innovation, funded by the FDA to support new regulatory assessment tools.
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1. Introduction to regulatory affairs (2).pptx
Regulatory affairs plays a crucial role in the pharmaceutical industry and is involved in all stages of drug development as well as after drug approval and marketing. Regulatory affairs professionals ensure that products contribute to public health by controlling safety and efficacy through compliance with regulations. They provide strategic and technical advice throughout development and registration of products with regulatory agencies. The scope of regulatory affairs includes pharmaceuticals, medical devices, diagnostics, biologics, and other health-related products.
Regulatory affairs in Pharmaceutical Industry
Regulatory affairs is a profession developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Strategic decision making.pptx
Strategic decision making in pharmacological companies.
Techno managerial aspects in pharmacological companies.
Regulations of biotechnological products
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Regulatory affairs professionals ensure that pharmaceutical products comply with regulations throughout the development, manufacturing, and marketing processes. They advise internal departments and collect data to submit to regulatory agencies for approvals. Dossiers containing technical documents are submitted for registration. Modules cover administrative information, quality overview, chemistry and manufacturing controls for drug substances and products, preclinical data, and clinical trial results. Regulatory professionals help companies avoid issues by properly managing records, data, and agency requirements.
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The document provides information about preparing for a career in the pharmaceutical industry. It discusses the pros and cons of working in the industry, some key statistics about the industry, and how the industry is changing and responding to challenges. It provides tips for how to prepare for an interview, improve chances of getting a job, and what skills are needed at different stages of the research and development process. The industry is still profitable but facing pressures to reduce costs through consolidation and outsourcing while demand for new drugs grows.
regulatory requirements of biologicals.pptx
Biologics are complex protein structures derived from living organisms. Their development and regulation involves several key aspects not required for conventional drugs, including additional pre-clinical toxicology and manufacturing studies as well as special programs like orphan drug designation. The IND and BLA processes require comprehensive documentation of quality, safety and efficacy. After approval, biologics face ongoing post-market safety reporting and review of any manufacturing changes to ensure continued patient protection.
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The document describes the Master of Science in Regulatory Science program offered by the University of Maryland School of Pharmacy. The two-year program can be completed part-time and exclusively online, with five courses taken over five semesters. The science-driven program focuses on drug development and regulation, and teaches skills like developing global drug strategies and differentiating regulatory requirements. Graduates will be prepared for regulatory careers in government agencies like the FDA or in the pharmaceutical industry. The program is complemented by the University's Center of Excellence in Regulatory Science and Innovation, funded by the FDA to support new regulatory assessment tools.
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In this video you will know the detailed information about:
🔸Departments of the manufacturing sites.
🔸Steps of drug product development.
🔸Regulatory Affairs department.
🔸Registration pathway.
🔸Product Type (Innovator "RLD" / Generic / Hybrid).
🔸All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country.
🔸The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health.
https://youtu.be/edUEFt681iM
#asmaa_khalil_ctd
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1. introduction to industrial pharma 5 8-2020
This document provides an overview of industrial pharmacy and the various departments within a pharmaceutical industry. It discusses the manufacturing department including the dispensing, production, and packaging/labeling units. It also describes the research and development, marketing, quality control, engineering, and accounting departments. The document outlines some key aspects of industrial pharmacy like pilot plant scale up techniques, technology development and transfer, regulatory affairs, regulatory requirements for drug approval, quality management systems, and Indian regulatory requirements.
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Institute of Good Manufacturing Practices India, registered as a non-profit society with Government of India and a member (as a higher/professional Education Institute) of Quality Council of India(QCI) -which is an autonomous body and an accreditation authority for education & vocational training providers under the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing. GMP in itself is the most dynamic part which witnesses frequent changes in terms of newer rules being added and older ones being renewed. Keeping self updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices.
Our group of learned professionals from above mentioned sectors of the pharma and healthcare industries have put together their knowledge; know about and practical experiences in form of this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as stronger and better training & distance and e-learning platform provider for pharmaceutical and healthcare professionals in the aeas of GMP, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. The importance of quality healthcare is known to our founders and thus numerous efforts are being made to offer friendly but effective and easy online/distance sources of GMP information, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice in form of online seminars, distance/online courses as well as training programmes along with knowledge of worldwide affairs of the industry; in short a round-the-clock help for any information in these areas needed by anybody from around the world. Based on high standard of quality, the training programmes in Pharma and healthcare GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management etc areas have been approved and certified by Quality Council of India.
The IGMPIs team of technology experts and other Industry advisors together pursue to make cGMP knowledge, training in the area of Pharma and healthcare manufacturing easily accessible, through this platform.
Resume
Ms. Prexa Nitin Shah is seeking a position in regulatory affairs or quality assurance. She has a Master's degree in regulatory affairs from Northeastern University and a Bachelor's degree in pharmacy from Gujarat Technological University. She has experience as a quality technician at Invatech Pharma Solutions and as a quality assurance associate at Intas Pharmaceuticals. She is skilled in FDA submissions and global drug regulations. She also has strong documentation, analytical, and communication skills.
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The document summarizes the drug development process and the role of medical affairs departments within pharmaceutical companies. It discusses the various phases of clinical drug trials from phase I to phase IV. It then outlines the structure and responsibilities of medical affairs, including clinical research, pharmacovigilance, medical information services, statistics management, and providing medical support to marketing and sales teams. A key part of medical affairs is the medical science liaison program which aims to educate medical professionals and support clinical trial recruitment through relationship building.
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This document discusses the challenges and opportunities for information management in the biopharma industries. It covers topics like challenges in R&D, clinical trials, sales and marketing productivity. It also discusses the evolving biopharma value chain and how information management can help in areas like pharmaceutical R&D, clinical operations, sales, marketing, manufacturing and supply chain optimization. Finally, it discusses how the pharmaceutical industry is at a crossroads with challenges like declining R&D productivity and changing market landscapes in emerging markets and developed nations.
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This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
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UNIT 3A REGULATORY AFFAIRS.pptx
The document provides an overview of regulatory affairs. It discusses the historical development of regulation, including key events that led to increased regulation of drugs and medical products. It also outlines the roles and responsibilities of regulatory affairs departments and professionals in submitting information and ensuring compliance with regulations from agencies like the FDA to obtain approval to market products. The goal of regulatory affairs is to protect public health by ensuring safety, efficacy and quality of drugs and other medical products.
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The document discusses emerging trends in the biopharmaceutical industry in India. It notes that the Indian biotech industry has grown to over $2 billion and biopharma remains the largest contributor. It outlines various management strategies Indian pharmaceutical firms have taken regarding biotechnology, including contract research and entering the biogenerics market. It also discusses problems the sector faces, such as high drug discovery costs and intellectual property protection, and recommendations to address these issues like allowing early phase clinical trials and reforming patent laws. Emerging trends include increasing government support, regulatory reforms, and more international collaboration.
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Product type- Drug development - Departments of facility- Registration pathwa...
In this video you will know the detailed information about:
🔸Departments of the manufacturing sites.
🔸Steps of drug product development.
🔸Regulatory Affairs department.
🔸Registration pathway.
🔸Product Type (Innovator "RLD" / Generic / Hybrid).
🔸All medicines must grant a Marketing Authorization (MA) in order to be placed on the market legally in the country.
🔸The ultimate purpose of marketing authorization is to ensure that safe, effective & high-quality medicines, as to protect public health.
https://youtu.be/edUEFt681iM
#asmaa_khalil_ctd
Innovative Marketing Practices for Optimization in Selected Pharmaceutical In...
Pharmaceutical Industry is regulated by the production, distribution, selling and the marketing of the products or services which directly or indirectly includes medical, diagnostic and healthcare.It is regulated by economical, political and administrative authority to manage at all levels. So, the industry is governed by both the public and private sector. Therefore innovation is done in various pharma stakeholder and is needed in chronic and acute therapeutic segment.
For more details please visit
www.iicecollege.com
1. introduction to industrial pharma 5 8-2020
This document provides an overview of industrial pharmacy and the various departments within a pharmaceutical industry. It discusses the manufacturing department including the dispensing, production, and packaging/labeling units. It also describes the research and development, marketing, quality control, engineering, and accounting departments. The document outlines some key aspects of industrial pharmacy like pilot plant scale up techniques, technology development and transfer, regulatory affairs, regulatory requirements for drug approval, quality management systems, and Indian regulatory requirements.
Accelerating Bio-Pharma's Marketing Transformation
Here's what bio-pharma organizations need to know when transforming the promotional material review and approval process from a transactional requirement to a competitive advantage.
Pharma regulatory affairs
Institute of Good Manufacturing Practices India, registered as a non-profit society with Government of India and a member (as a higher/professional Education Institute) of Quality Council of India(QCI) -which is an autonomous body and an accreditation authority for education & vocational training providers under the Department of Industrial Policy & Promotion, Ministry of Commerce & Industry, Government of India -presents unique, friendly and interactive platform to get rid of all your GMP related glitches. GMP- is an essential element of industries like pharmaceutical, cosmetic, Ayurveda, biotech, homeopathic, medical device and food manufacturing. GMP in itself is the most dynamic part which witnesses frequent changes in terms of newer rules being added and older ones being renewed. Keeping self updated with current GMPs thus becomes inevitable to stay abreast with the changing industry needs and practices.
Our group of learned professionals from above mentioned sectors of the pharma and healthcare industries have put together their knowledge; know about and practical experiences in form of this GMP guide. IGMPI is moving hand in hand with technology advances and has gained recognition as stronger and better training & distance and e-learning platform provider for pharmaceutical and healthcare professionals in the aeas of GMP, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice and Product Management. The importance of quality healthcare is known to our founders and thus numerous efforts are being made to offer friendly but effective and easy online/distance sources of GMP information, Quality Assurance and Control, Pharma and healthcare Regulatory Affairs, Clinical Research, Pharmaceutical IPR and Good Laboratory Practice in form of online seminars, distance/online courses as well as training programmes along with knowledge of worldwide affairs of the industry; in short a round-the-clock help for any information in these areas needed by anybody from around the world. Based on high standard of quality, the training programmes in Pharma and healthcare GMP, Quality Assurance and Quality Control, Regulatory Affairs, IPR, Pharma Product Management etc areas have been approved and certified by Quality Council of India.
The IGMPIs team of technology experts and other Industry advisors together pursue to make cGMP knowledge, training in the area of Pharma and healthcare manufacturing easily accessible, through this platform.
Resume
Ms. Prexa Nitin Shah is seeking a position in regulatory affairs or quality assurance. She has a Master's degree in regulatory affairs from Northeastern University and a Bachelor's degree in pharmacy from Gujarat Technological University. She has experience as a quality technician at Invatech Pharma Solutions and as a quality assurance associate at Intas Pharmaceuticals. She is skilled in FDA submissions and global drug regulations. She also has strong documentation, analytical, and communication skills.
Medical affairs department for small organization
The document summarizes the drug development process and the role of medical affairs departments within pharmaceutical companies. It discusses the various phases of clinical drug trials from phase I to phase IV. It then outlines the structure and responsibilities of medical affairs, including clinical research, pharmacovigilance, medical information services, statistics management, and providing medical support to marketing and sales teams. A key part of medical affairs is the medical science liaison program which aims to educate medical professionals and support clinical trial recruitment through relationship building.
CHRS Biotechnology Brochure
Biotechnology, pharmaceutical, and medical device companies can partner with Cardinal Health Regulatory Sciences for additional resources and expertise throughout the biologics development process. Cardinal Health offers services including product development strategies, regulatory documentation preparation, facility inspections, and global regulatory strategies. Their experience includes over 100 product approvals across therapeutic areas. Partnering with Cardinal Health can help companies facilitate multinational approvals and achieve greater returns on development investments.
Bilcare_GCS Quality and Regulatory Overiew
Bilcare is committed to providing innovative clinical trial material supply services globally according to quality and regulatory standards. It offers services including clinical trial manufacturing, packaging, labeling, sourcing of drugs, and storage and distribution. Bilcare aims to provide cost-effective and creative solutions through strategic partnerships to help customers succeed. It focuses on customer satisfaction, continual self-improvement, and compliance with regulations like cGMP, GCP, and ISO 9001. Bilcare works to improve through learning from audits and implementing systems improvements.
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The document provides an overview of various areas of pharmacy including hospital pharmacy, clinical pharmacy, industrial pharmacy, retail pharmacy, and pharmacy education. It discusses the roles and responsibilities of pharmacists in different settings such as hospitals, industry, and retail. It also outlines the scope of pharmacy practice and career opportunities available to pharmacists in areas like academics, marketing, research, and government.
Information Management in Pharmaceutical Industry
This document discusses the challenges and opportunities for information management in the biopharma industries. It covers topics like challenges in R&D, clinical trials, sales and marketing productivity. It also discusses the evolving biopharma value chain and how information management can help in areas like pharmaceutical R&D, clinical operations, sales, marketing, manufacturing and supply chain optimization. Finally, it discusses how the pharmaceutical industry is at a crossroads with challenges like declining R&D productivity and changing market landscapes in emerging markets and developed nations.
Drug Regulatory Affairs
This document provides an overview of regulatory affairs for drugs. It defines key terms like regulatory affairs, dossier, CTD, eCTD, DMF, NDA, ANDA, and INDA. It describes the role of regulatory affairs experts in guiding product development according to regulatory requirements, compiling dossiers for submission, and ensuring post-marketing compliance. The document outlines a 10 step process for regulatory product development and regulatory submission preparation. It also discusses quality management systems for regulatory compliance and the role of regulatory affairs in marketing and advertising compliance.
Biosimilars Webinar June 29, 2016 Slides
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Date: June 29, 2016
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Hi, everyone i am providing you the best presentation about the Pakistan relate Drug regulatory affairs and the concept of regulatory affairs of Pharmaceuticals
SMi Group's 4th annual Biosimilars & Biobetters conference
This document provides information about the "Biosimilars & Biobetters" conference being held on October 1-2, 2013 in London. The conference will discuss guidelines for biosimilars and biobetters from regulatory bodies, market access pathways, intellectual property, clinical development processes, and case studies on successful products. It will also feature two half-day workshops on developing marketing plans and the commercial realities of biosimilars. The conference is aimed at professionals in areas like regulatory affairs, clinical development, marketing, and intellectual property for pharmaceutical and biotechnology companies.
UNIT 3A REGULATORY AFFAIRS.pptx
The document provides an overview of regulatory affairs. It discusses the historical development of regulation, including key events that led to increased regulation of drugs and medical products. It also outlines the roles and responsibilities of regulatory affairs departments and professionals in submitting information and ensuring compliance with regulations from agencies like the FDA to obtain approval to market products. The goal of regulatory affairs is to protect public health by ensuring safety, efficacy and quality of drugs and other medical products.
INC Research Consulting v1
INC Research is a global consulting firm that provides advisory and implementation support services to the biopharmaceutical industry. They help clients with development, regulatory, quality and compliance, pharmacovigilance, and market development. Their team of over 50 consultants uses therapeutic expertise and consulting frameworks to deliver strategic solutions and help clients achieve their business goals.
new management trends in biopharmaceuticals
The document discusses emerging trends in the biopharmaceutical industry in India. It notes that the Indian biotech industry has grown to over $2 billion and biopharma remains the largest contributor. It outlines various management strategies Indian pharmaceutical firms have taken regarding biotechnology, including contract research and entering the biogenerics market. It also discusses problems the sector faces, such as high drug discovery costs and intellectual property protection, and recommendations to address these issues like allowing early phase clinical trials and reforming patent laws. Emerging trends include increasing government support, regulatory reforms, and more international collaboration.
Presentation: Regulatory reforms at the Therapeutic Goods Administration
An overview recommendations from the Review of Medicines and Medical Devices Regulation relating to low risk therapeutic goods.
Spotlight on MMDR Further Reviews and Advertising Reforms
An overview of reform initiatives relating to low risk therapeutic goods and the scheduling policy framework arising from the Review of Medicines and Medical Devices Regulation.
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Product type- Drug development - Departments of facility- Registration pathwa...
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Innovative Marketing Practices for Optimization in Selected Pharmaceutical In...
Accelerating Bio-Pharma's Marketing Transformation
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SMi Group's 4th annual Biosimilars & Biobetters conference
SMi Group's 4th annual Biosimilars & Biobetters conference
Presentation: Regulatory reforms at the Therapeutic Goods Administration
Presentation: Regulatory reforms at the Therapeutic Goods Administration
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Remote Sensing and Geographic Information Systems
9
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structure of plant communities across different temporal and spatial scales. These changes can
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Date: May 29, 2024
Tags: Information Security, ISO/IEC 27001, ISO/IEC 42001, Artificial Intelligence, GDPR
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