The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)Naman Ruhela
A Brief Introduction about the Regulatory Affairs / Drug Regulatory Affairs (DRA). Introduction to Drug Regulatory Affairs. Why Drug Regulatory Affairs?. Role of Regulatory Affairs Experts. Types of the company hiring RA professionals. RA professional can get employment. Regulatory Bodies.
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
The presentation is about: Drug Regulatory Affairs as a profession, Scope & Responsibilities in life cycle management of a drug and role of RA in the drug approval process.
DRA (Drug Regulatory Affairs) , RA (Regulatory Affairs)Naman Ruhela
A Brief Introduction about the Regulatory Affairs / Drug Regulatory Affairs (DRA). Introduction to Drug Regulatory Affairs. Why Drug Regulatory Affairs?. Role of Regulatory Affairs Experts. Types of the company hiring RA professionals. RA professional can get employment. Regulatory Bodies.
Regulatory requirements for drug approval - industrial pharmacy IIJafarali Masi
Regulatory requirements for drug approval - industrial pharmacy IIDrug Development Teams, Non-Clinical Drug Development, Pharmacology, Drug Metabolism and Toxicology, General considerations of Investigational New Drug (IND) Application, Investigator’s Brochure (IB) and New Drug Application (NDA), Clinical research / BE studies, Clinical Research Protocols, Biostatistics in Pharmaceutical Product Development, Data Presentation for FDA Submissions, Management of Clinical Studies.
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
RA is a comparatively new profession which developed from the desire of governments to protect public health by controlling the Quality, safety and efficacy of products in areas including pharmaceuticals, Biotechnology, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Goals of Regulatory Affairs Professionals:-
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
Introduction to Pharma regulatory affairsGIBT India
It constitutes of basic introduction of regulatory affairs in pharmaceuticals, career in pharma regulatory affairs, job opportunities and future aspect. GIBTIndia offers job oriented e- learning courses. Kindly visit us at www.gibtindia.com
Focus Institute of Clinical Research promises to be a revolution in itself, in providing market driven superior content, well maintained infrastructure, in-house personality development series for learning and also act as a launch pad for student & professional development. Technologically driven with expert support from the industry, education provided by Focus Educare is innovative and market friendly.
Fundamental concept of regulatory affairs in pharmaceutical & biotechnologyHitendra Singh
RA is a comparatively new profession which developed from the desire of governments to protect public health by controlling the Quality, safety and efficacy of products in areas including pharmaceuticals, Biotechnology, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines.
Goals of Regulatory Affairs Professionals:-
Protection of human health
Ensuring safety, efficacy and quality of drugs
Ensuring appropriateness and accuracy of product information
Outsourcing is a Cost-effective strategy when used properly and at present is gaining more and more importance. Here's a short presentation about the importance of outsourcing in Clinical research.
Introduction to Pharma regulatory affairsGIBT India
It constitutes of basic introduction of regulatory affairs in pharmaceuticals, career in pharma regulatory affairs, job opportunities and future aspect. GIBTIndia offers job oriented e- learning courses. Kindly visit us at www.gibtindia.com
Focus Institute of Clinical Research promises to be a revolution in itself, in providing market driven superior content, well maintained infrastructure, in-house personality development series for learning and also act as a launch pad for student & professional development. Technologically driven with expert support from the industry, education provided by Focus Educare is innovative and market friendly.
Role & responsibilities of a clinical research coordinatorRadhika Nagare
Clinical Research Coordinator (CRC) is a specialized research person working with and under the direction of the Principal Investigator .While the Principal Investigator(PI) is primarily responsible for the overall designing, conducting, and management of the clinical trial, the CRC supports, and coordinates the regular clinical trial activities and plays a crucial role in the conduct of the study. By doing these duties, the CRC works with the PI, sponsor ,department, and institution to support and provide guidance on every related aspects of the study.
Clinical Research Associate (CRA) - A Growing Career Path in Biotechnology / ...SOCRA CCRP Certification
SOCRA study guide - ES’ SOCRA CCRP Exam Study Guide – A resource to help those who is preparing for the SOCRA Certified Clinical Research Professional (CCRP) certification.
Historical background and development of profession of pharmacy: History of profession of Pharmacy in India in relation to pharmacy education, industry and organization, Pharmacy as a career, Pharmacopoeias: Introduction to IP, BP, USP and Extra Pharmacopoeia.
HISTORICAL BACKGROUND & DEVELOPMENT OF PROFESSION OF PHARMACYTeny Thomas
The following presentation deals with what the course of pharmacy is and what a pharmacist is. Also a short brief on the historical growth of the profession of pharmacy when related to education and industry is also discussed here. A detailed view on career in pharmacy is described lastly.
Value creation through business innovation in the pharmaceutical and medical ...N de Jong
The need for innovation as a priority in the pharmaceutical and medical technology sector remains consistently high. The Bridge business innovators researched the market most recently in 2010: in nearly 81% of the companies, the subject of innovation was given high or highest priority.
The pharmaceutical and medical technology sector is in a complete state of flux: hospital-at-home care, the effects of the preference policy, the diminishing influence of medical sales representatives, and the rise of new revenue models in health care are all examples of the changes currently taking place in the market.
The sector realizes that the changes are creating opportunities for growth. As a result, the sector is embracing the changes, which are leading to business innovations within the industries. By business innovation we mean “the creation and profitable use of the new.” It is a skill and an art to transform change into growth for the business.
In this publication we will describe several significant trends and developments. These trends create opportunities. The opportunities are filtered through a business innovation “lens”. This business innovation lens includes twelve ways to innovate and create new value.
Pharmaceutical industry is a very vital segment of the
our health care system, which deals with manufacturing
and marketing of pharmaceuticals and biological
products and medicinal devices, used for the diagnosis
and treatment of diseases as well as conducts research
for development of new products for human welfare
TQM involves
building quality in a pharmaceutical product as it
involve complete records such as standard operating
procedures for every step, validation records, master
formula records and batch production records etc.
2. INTRODUCTION
The Global Industry Classification further distinguish the industry as
two main groups:
Health care equipment and services; and
Pharmaceuticals, biotechnology and related life sciences.
3. HEALTHCARE
The health care industry, also termed as medical industry, is an aggregation of
sectors within the system that provides goods and services to treat patients
with curative, preventive, rehabilitative, and palliative care.
The health care equipment and services group consists of companies provide
Medical equipment,
Medical supplies, and
Health care services, such as hospitals, home health care providers,
and nursing homes.
4. PHARMACEUTICALS
The Pharmaceuticals, biotechnology group includes companies that produce
Biotechnology,
Pharmaceuticals, and
Miscellaneous scientific services.
The pharmaceutical industry develops, produces, and
markets drugs or pharmaceuticals licensed for use as medications.
Pharmaceutical companies are allowed to deal in generic or brand medications and
medical devices.
5. Reputed Company Names
Healthcare
Sanofi
Hoffman la Roche
Johnson and Johnson
Novartis
Pharmaceuticals
Catalent MSP
DuPont
BASF
Amgen