Role of IT in Pharma Industry, Role of Pharm Industry in Indian GDP, Role of Engineers in Pharmaceutical Industry, PHARMACY INFORMATICS, Importance in Pharma Industry, Pharmacy management software, Computerized Physician Order Entry (CPOE), Bar-coded medication administration, Enterprise Resource Planning (ERP), Laboratory Information Management System (LIMS), Customer Relationship Management (CRM), Sales Force Automation (SFA) Software, Electronic Batch Records (EBR) Software
Some of the software use in pharmaceuticals Research & Development, Virtual Labs.
IMPLANTS
MEDICAL DEVICES
REGULATIONS IN INDIA
CLASSIFICATION OF MEDICAL DEVICES{CDSCO, FDA}
IMPLANTS
CLASSIFICATION OF IMPLANTS
IMPLANTABLE MEDICAL DEVICES
RISKS RELATED TO IMPLANTS
ADVANTAGES & DISADVANTAGES
Japan drug and cosmetics regulation.pdfBhavikaAPatel
Japan drug and cosmetics regulation
information about
organisation of PMDA
Function of PMDA
IND and NDA application
Classification of drug product
Types of Application
DMF system in Japan
Post marketing surveillance
Importing cosmetics in Japan
IMPLANTS
MEDICAL DEVICES
REGULATIONS IN INDIA
CLASSIFICATION OF MEDICAL DEVICES{CDSCO, FDA}
IMPLANTS
CLASSIFICATION OF IMPLANTS
IMPLANTABLE MEDICAL DEVICES
RISKS RELATED TO IMPLANTS
ADVANTAGES & DISADVANTAGES
Japan drug and cosmetics regulation.pdfBhavikaAPatel
Japan drug and cosmetics regulation
information about
organisation of PMDA
Function of PMDA
IND and NDA application
Classification of drug product
Types of Application
DMF system in Japan
Post marketing surveillance
Importing cosmetics in Japan
regulations for combination products .KeerthanaN20
Combination product includes:
(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
(2) Two or more separate products packaged together in a single package or as a unit .
(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose;
Bruno Flamion, Professor of Physiology and Pharmacology, Molecular Physiology Research Unit, University of Namur
Presentation at EIPG – VAPI-UPIP Symposium “Biotech and Advanced Therapies: Challenges and Opportunities” at the Faculty of Medicine and Pharmacy, Campus Jette, Vrije Universiteit van Brussel, Brussels 2013
Combination Products, Orphan Drugs, and OTC DrugsMichael Swit
Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
> Why HEOR?
> Costs, Consequences and Perspectives
> Key Stakeholders in HEOR
> What is Health Economics and Pharmaco-economic Research?
> Economic Evaluations
> Incremental Cost Effectiveness Ratio (ICER)
> Concept of HRQoL
> Comparative Effectiveness Research (CER)
> Pragmatic Clinical Trials
> Observational Studies
> Systematic Reviews and Meta-Analysis
> Application of CER
> Health Technology Assessment (HTA)
> Real World Evidence (RWE)
> Patient Reported Outcomes (PROs)
> Patient Focused Drug Development (PFDD)
> Application of Health Economic Evaluations
> Challenges and Barriers
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
regulations for combination products .KeerthanaN20
Combination product includes:
(1) A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;
(2) Two or more separate products packaged together in a single package or as a unit .
(3) A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved individually specified drug, device, or biological product where both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labeling of the approved product would need to be changed, e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose;
Bruno Flamion, Professor of Physiology and Pharmacology, Molecular Physiology Research Unit, University of Namur
Presentation at EIPG – VAPI-UPIP Symposium “Biotech and Advanced Therapies: Challenges and Opportunities” at the Faculty of Medicine and Pharmacy, Campus Jette, Vrije Universiteit van Brussel, Brussels 2013
Combination Products, Orphan Drugs, and OTC DrugsMichael Swit
Presentation to the San Diego Regulatory Affairs Network (SDRAN) Regulatory Affairs Certification (RAC) Exam review course on FDA regulation of combination products, orphan drugs, and OTC drugs.
The Therapeutic Goods Administration or TGA is the regulatory body for therapeutic goods in Australia.
The TGA is responsible for conducting assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard.
> Why HEOR?
> Costs, Consequences and Perspectives
> Key Stakeholders in HEOR
> What is Health Economics and Pharmaco-economic Research?
> Economic Evaluations
> Incremental Cost Effectiveness Ratio (ICER)
> Concept of HRQoL
> Comparative Effectiveness Research (CER)
> Pragmatic Clinical Trials
> Observational Studies
> Systematic Reviews and Meta-Analysis
> Application of CER
> Health Technology Assessment (HTA)
> Real World Evidence (RWE)
> Patient Reported Outcomes (PROs)
> Patient Focused Drug Development (PFDD)
> Application of Health Economic Evaluations
> Challenges and Barriers
Software as a Medical Device (SaMD) Challenges and Opportunities for 2021 and...Greenlight Guru
The SARS-CoV-2 pandemic drastically changes the landscape of digital health innovation. The FDA authorized emergency use for a variety of SaMD products including but not limited to mental health, clinical decision support and remote monitoring software applications. In addition, FDA recently launched the Digital Health Center of Excellence, provided updates on the pre-certification program, and host a session to convey FDA’s current thinking on AI/ML SaMD validation.
SaMD manufacturers must keep up with the fast-evolving regulatory landscape and optimize their software development practices with a goal to demonstrate conformance to the QMS requirements effectively and efficiently.
This presentation originally aired during the 2021 State of Medical Device Virtual Summit.
Madison Park Group Life Sciences Software Market Update H2 2018Madison Park Group
We are pleased to present our review of the life sciences software market for the first half of 2018.
Madison Park Group is a unique investment banking firm that takes a "strategy first" approach to advising software companies. Our partners have developed and advised numerous successful companies as operators, investors and investment bankers.
Rohan Khanna and Jon Adler spearhead the firm's efforts in the life sciences software market.
Practice Management System Market Share and Size, 2018 to 2024Signitech
The global practice management system market size was valued at USD 6.9 billion in 2015. The industry is majorly driven by its competence to bring efficiency in healthcare delivery.
Healthcare Interoperability Solutions Market by Product Type, Distribution Ch...IMARC Group
The global healthcare interoperability solutions market size reached US$ 3.9 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 11.0 Billion by 2032, exhibiting a growth rate (CAGR) of 12.24% during 2024-2032.
More Info:- https://www.imarcgroup.com/healthcare-interoperability-solutions-market
A dispensary is a place, a career, and in some cases, a company's business. A dispensary is a place, where the licensed pharmacists of medicines, based on a prescription issued by a legitimate doctor. A pharmacy is a pharmacy. Some of the companies do not have pharmacies, but they will sell medicines bought without a prescription. In a pharmacy, it can be a stand-alone building, or it can be to be found in other locations as well, such as a pharmacy, a medical office or a hospital. Pharmacists are registered with the Pharmaceutical Council and have been designated as registered pharmacists. However, this is a title that is only awarded after the passing of a truly national and practical and legal studies. Pharmacists must always be vigilant against fake prescriptions ordered due to the addicts who are trying to illegally obtain drugs and other controlled substances. The pharmacy also means that it is in the practice of pharmacy as a profession. Pharmacy has a rich appeal. With the availability of computers and the development of the advances in information technology have led to the fact that we have the ability to quickly and efficiently, to receive or collect to analyze, transfer, and storage of large amounts of information related to patient care.
Medical Document Management Systems Market by Product Type, Distribution Chan...IMARC Group
The global medical document management systems market size reached US$ 551.0 Million in 2022. Looking forward, IMARC Group expects the market to reach US$ 1,111.7 Million by 2028, exhibiting a growth rate (CAGR) of 11.9% during 2023-2028.
More Info:- https://www.imarcgroup.com/medical-document-management-systems-market
PharmaLedger Press Release #2 June 2020 PharmaLedger
PharmaLedgers June 2020 press release covers the strong foundations in the project’s first year and how it set the stage for accelerated development and ecosystem engagement.
The press release also announces the establishment of PharmaLedger’s Advisory Board and the outlook for 2021.
—
This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853992. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.
Disclaimer: Any information on this presentation solely reflects the author’s view and neither IMI nor the European Union or EFPIA are responsible for any use that may be made of the information contained herein.
Intro to informatics pharmacist by Linus LayLinus Lay
Presented by Linus Lay, Pharm.D. Candidate from the University of Rhode Island Class of 2022.
This presentation was in-service to RxInsider, a B2B multimedia publishing and technology company for the "business of pharmacy." Pharmacy Informatics is a rising field in the specialties of pharmacy. This presentation provides a brief background on the responsibilities of an informatics pharmacist, short history of the specialty curriculum, and the current education for the field of informatics for student pharmacists.
View MyCred Portfolio: https://mycred.com/p/2929377185
View Youtube Video: https://youtu.be/WTi2ldztl2I
Indian Regulatory Requirements: Central Drugs Standard Control Organization (CDSCO). The Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India is the National Regulatory Authority (NRA) of India. The Drugs & Cosmetics Act,1940 and rules 1945 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. Vision:
To Protect and Promote public health in India.
Mission:
To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices. Functions of CDSCO
Certificate of Pharmaceutical Product (COPP): The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO).
COPP establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country.
It is often mentioned in conjunction with the electronic Common Technical Document (eCTD). The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country. The Certificate of a Pharmaceutical Product is needed by the importing country when the product in question is intended for registration (licensing, authorization) or renewal (prolongation) of registration, with the scope of commercialization or distribution in that country.
COPP Importance: It is needed by the importing country when the product in question is infected for Registration (Licensing and Authorization) or renewal of registration.
With the scope of commercialization or distribution in that country.
Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality assurance facilities in importing countries to assess the quality of pharmaceutical products as a prerequisite of registration or importation. General Requirements for Submission of Application for Issue of COPP. Documents Required for Applying for Grating or
Revalidation of COPPS:
Application from the manufacturer.
Site master file (as specified under WHO TRS 823).
Cost of manufacturing license.
List of approved products.
List of products applied for issuance of COPPS.
List of SOPs and STPs.
Stability data (3 batches) accelerated/Real-time.
List of equipments and instruments.
List of technical staff, their qualification, and experience, and approval status.
Manufacturing layout plan.
Process validation for 3 batches of each product.
Schematic diagram of water system specifying circulation loop and MOC (Material of construction).
Schematic diagram of HVAC system specifying terminal filter configuration. Export data of the last 2 years in case of revalidation.
Flow chart
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy and banking.
History of regulatory affair. Various Regulatory Authority. Role of Regulatory Affairs Department.
Pre-clinical or Non- clinical phase of drug development . Investigational New Drug Application (IND) Importance of IND. Investigator’s Brochure (IB). The Investigator’s Brochure (IB) is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. A complete and thorough investigator’s brochure should include the following: Title Page
I. A] Confidentiality Statement
II. Contents of the Investigator’s Brochure
II. A] Table of Contents
II. B] Summary
II. C] Introduction
II. D] Physical, Chemical, and Pharmaceutical Properties and
Formulation
II. E] Nonclinical Studies
II. F] Effects in Humans
II. G] Summary of Data and Guidance for the Investigator. Contents of the Investigator’s Brochure: II. A] Table of Contents
II. B] Summary:
Not longer than 2 pages.
Highlighting significant physical, chemical, pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic and clinical information available that is relevant to the state of clinical development of the investigational product. II. D] Physical, Chemical, and Pharmaceutical Properties
and Formulation:
A description of the investigational product substances including the chemical and or structural formulae and the brief summary of the relevant physical, chemical and pharmaceutical properties.
For safety measures, a description of the formulations to be used including excipients (a substance formulated with the active ingredient of a medication) should be provided and justified if clinically relevant.
Instructions for the storage and handling of the dosage should be provided.
Structural similarities to other known compounds should be mentioned. Pharmacokinetics and Product Metabolism in Humans
A summary of information on the pharmacokinetics of the investigational product(s) should be presented, including the following, if available:
Pharmacokinetics (including metabolism, as appropriate, and absorption, plasma protein binding, distribution and elimination).
Bioavailability of the investigational product (absolute, where possible, and/or relative) using a reference dosage form.
Population subgroups (e.g. gender, age, and impaired organ function).
Interactions (e.g. product-product interactions and effects of food).
Other pharmacokinetic data (e.g. results of population studies performed within clinical trial(s). . Marketing Experience
The Investigator’s Brochure should identify countries where the investigational product has been approved.
technology transfer documents confidentiality agreements, licensing, mous.pdfDr. Ambekar Abdul Wahid
A confidentiality agreement also called a nondisclosure agreement or NDA.
It is a legally binding contract in which a person or business promises to treat specific information as a trade secret and promises not to disclose the secret to others without proper authorization.
Licensing is one of those terms that are used quite frequently and hold high importance.
Licensing can be defined as a contract or agreement between two companies, where one company permits another company to manufacture its products under specified conditions and for a specified payment. Different types of licensing
The Asian and Pacific Centre for Transfer of Technology (APCTT) is a regional institution of the United Nations Economic and Social Commission for Asia and the Pacific (ESCAP) servicing the Asia-Pacific region.
The National Research Development Corporation (NRDC) was a non departmental government body established by the British Government to transfer technology from the public sector to the private sector.
TIFAC is an autonomous organization set up in 1988 under the Department of Science & Technology to look ahead in technology domain, assess the technology trajectories, and support innovation by networked actions in select areas of national importance.
Biotech Consortium India Limited (BCIL) is a public limited company, promoted by the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India and set up by All India Financial Institutions including IDBI, ICICI, IFCI, UTI and IFCI Venture Capital Funds Limited.
A platform is a group of technologies that are used as a base
or infrastructure upon which other applications, technologies
or processes are developed for the end-user.
“a common or standard method, equipment, procedure or work practice that may be applied to the research, development or manufacturing of different products ” An array of multi-disciplinary technologies covering major aspects of the drug discovery and development processes have been established in Institute of Biotechnology and Pharmaceutical Research (IBPR)
PILOT PLANT SCALE- UP TECHNIQUE
Plant, Pilot Plant, Scale-up, Objective, Significance, Steps in scale up, General considerations, Master Manufacturing Procedures, GMP consideration.
Granularity of Technology Transfer Process, Documentation, Premises and equipment Qualification and Validation. Premises and equipments. Quality control: Analytical Method Transfer. Qualification and Validation
Drug and magic remedies (objectionable advertisement) act 1954 and rules 1955Dr. Ambekar Abdul Wahid
Definitions, Class of Prohibitions Advertisement - Section 3, Classes of exempted advertisements, Powers of entry, search etc., Offenses and penalties, Scrutiny of misleading advertisements relating to drugs, Manner in which advertisements may be sent confidentially, Case Studies.
History, Objectives, Various Definitions, The Pharmacy Council of India (PCI), Functions and duties of PCI, State Pharmacy Council, Functions of The State PharmacyCouncils, Joint State Pharmacy Council, Offences and penalties and List of amending Acts and adaptation orders.
Brief History, Objectives, Various Definitions, Authorities and officers, The Narcotic Drugs and Psychotropic Substances Consultative Committee, National Fund for Control of Drug Abuse, Prohibition, Control And Regulation, Power to control and regulate controlled substances and Offences and Penalties, small quantity and a commercial quantity for some popular drugs and Amendments.
National Pharmaceutical Pricing Authority (NPPA) & Drug Price Control Order (...Dr. Ambekar Abdul Wahid
Introduction to NPPA, The Drug Regulatory System in India, NPPA Activities and Responsibility's, Function and Organization of NPPA, Introduction to DPCO 2013, Salient features of DPCO 2013, Prices of Bulk Drug, Retail price of Formulations, Pricing of Scheduled Formulations, Various Schedules related to DPCO Act and Amendments.
Introduction to D & C Act 1940 and Rules 1945, Definitions, Various Schedules in D & C Rules 1945, Administration of the act and rules, Manufacturing , Distribution and sale of drug and cosmetic, Labeling and Packing of drug and cosmetic.
The presentation is about the basics of Sprayer dryer, its design, types of systems, process stages, Schematic representation of spray drying mechanism, and its application.
Safalta Digital marketing institute in Noida, provide complete applications that encompass a huge range of virtual advertising and marketing additives, which includes search engine optimization, virtual communication advertising, pay-per-click on marketing, content material advertising, internet analytics, and greater. These university courses are designed for students who possess a comprehensive understanding of virtual marketing strategies and attributes.Safalta Digital Marketing Institute in Noida is a first choice for young individuals or students who are looking to start their careers in the field of digital advertising. The institute gives specialized courses designed and certification.
for beginners, providing thorough training in areas such as SEO, digital communication marketing, and PPC training in Noida. After finishing the program, students receive the certifications recognised by top different universitie, setting a strong foundation for a successful career in digital marketing.
Executive Directors Chat Leveraging AI for Diversity, Equity, and InclusionTechSoup
Let’s explore the intersection of technology and equity in the final session of our DEI series. Discover how AI tools, like ChatGPT, can be used to support and enhance your nonprofit's DEI initiatives. Participants will gain insights into practical AI applications and get tips for leveraging technology to advance their DEI goals.
Read| The latest issue of The Challenger is here! We are thrilled to announce that our school paper has qualified for the NATIONAL SCHOOLS PRESS CONFERENCE (NSPC) 2024. Thank you for your unwavering support and trust. Dive into the stories that made us stand out!
Delivering Micro-Credentials in Technical and Vocational Education and TrainingAG2 Design
Explore how micro-credentials are transforming Technical and Vocational Education and Training (TVET) with this comprehensive slide deck. Discover what micro-credentials are, their importance in TVET, the advantages they offer, and the insights from industry experts. Additionally, learn about the top software applications available for creating and managing micro-credentials. This presentation also includes valuable resources and a discussion on the future of these specialised certifications.
For more detailed information on delivering micro-credentials in TVET, visit this https://tvettrainer.com/delivering-micro-credentials-in-tvet/
Macroeconomics- Movie Location
This will be used as part of your Personal Professional Portfolio once graded.
Objective:
Prepare a presentation or a paper using research, basic comparative analysis, data organization and application of economic information. You will make an informed assessment of an economic climate outside of the United States to accomplish an entertainment industry objective.
This presentation includes basic of PCOS their pathology and treatment and also Ayurveda correlation of PCOS and Ayurvedic line of treatment mentioned in classics.
June 3, 2024 Anti-Semitism Letter Sent to MIT President Kornbluth and MIT Cor...Levi Shapiro
Letter from the Congress of the United States regarding Anti-Semitism sent June 3rd to MIT President Sally Kornbluth, MIT Corp Chair, Mark Gorenberg
Dear Dr. Kornbluth and Mr. Gorenberg,
The US House of Representatives is deeply concerned by ongoing and pervasive acts of antisemitic
harassment and intimidation at the Massachusetts Institute of Technology (MIT). Failing to act decisively to ensure a safe learning environment for all students would be a grave dereliction of your responsibilities as President of MIT and Chair of the MIT Corporation.
This Congress will not stand idly by and allow an environment hostile to Jewish students to persist. The House believes that your institution is in violation of Title VI of the Civil Rights Act, and the inability or
unwillingness to rectify this violation through action requires accountability.
Postsecondary education is a unique opportunity for students to learn and have their ideas and beliefs challenged. However, universities receiving hundreds of millions of federal funds annually have denied
students that opportunity and have been hijacked to become venues for the promotion of terrorism, antisemitic harassment and intimidation, unlawful encampments, and in some cases, assaults and riots.
The House of Representatives will not countenance the use of federal funds to indoctrinate students into hateful, antisemitic, anti-American supporters of terrorism. Investigations into campus antisemitism by the Committee on Education and the Workforce and the Committee on Ways and Means have been expanded into a Congress-wide probe across all relevant jurisdictions to address this national crisis. The undersigned Committees will conduct oversight into the use of federal funds at MIT and its learning environment under authorities granted to each Committee.
• The Committee on Education and the Workforce has been investigating your institution since December 7, 2023. The Committee has broad jurisdiction over postsecondary education, including its compliance with Title VI of the Civil Rights Act, campus safety concerns over disruptions to the learning environment, and the awarding of federal student aid under the Higher Education Act.
• The Committee on Oversight and Accountability is investigating the sources of funding and other support flowing to groups espousing pro-Hamas propaganda and engaged in antisemitic harassment and intimidation of students. The Committee on Oversight and Accountability is the principal oversight committee of the US House of Representatives and has broad authority to investigate “any matter” at “any time” under House Rule X.
• The Committee on Ways and Means has been investigating several universities since November 15, 2023, when the Committee held a hearing entitled From Ivory Towers to Dark Corners: Investigating the Nexus Between Antisemitism, Tax-Exempt Universities, and Terror Financing. The Committee followed the hearing with letters to those institutions on January 10, 202
MATATAG CURRICULUM: ASSESSING THE READINESS OF ELEM. PUBLIC SCHOOL TEACHERS I...NelTorrente
In this research, it concludes that while the readiness of teachers in Caloocan City to implement the MATATAG Curriculum is generally positive, targeted efforts in professional development, resource distribution, support networks, and comprehensive preparation can address the existing gaps and ensure successful curriculum implementation.
Normal Labour/ Stages of Labour/ Mechanism of LabourWasim Ak
Normal labor is also termed spontaneous labor, defined as the natural physiological process through which the fetus, placenta, and membranes are expelled from the uterus through the birth canal at term (37 to 42 weeks
Unit 8 - Information and Communication Technology (Paper I).pdfThiyagu K
This slides describes the basic concepts of ICT, basics of Email, Emerging Technology and Digital Initiatives in Education. This presentations aligns with the UGC Paper I syllabus.
Unit 8 - Information and Communication Technology (Paper I).pdf
Role of it in pharmaceutical industry
1. Role of IT in Pharma Industry
Dr. Ambekar Abdul Wahid
M. Pharm; Ph. D
Dr. Vithalrao Vikhe Patil Foundation’s
College of Pharmacy
Vilad Ghat; Ahmednagar (MS)
6/16/2021 1
2. • India is now among the top five emerging pharmaceutical
markets globally.
• And is a front runner in a wide range of specialties
involving complex drugs manufacture, development
and technology.
• The Indian pharmaceutical industry is a highly knowledge
-based industry which is growing steadily and plays a
major role in the Indian economy.
• (Last fiscal year, the sector contributed around 1.72 % to
the country’s GDP)
• Export: Drugs and pharma product 24.89% till
September 2020
6/16/2021 2
3. • In recent decades, technology has transformed
the way of life.
• It has influenced every sector of human life,
from communication, transport,
manufacturing, business with the medical and
pharmaceutical industry as a front-runner
beneficiary.
• Pharmacists are using the IT systems in the
modern age to build and formulate their daily
work more efficiently and effectively.
6/16/2021 3
4. Role of Engineers in Pharmaceutical Industry
Designing, building and improving manufacturing
facilities that produce drugs.
Handle increasingly complex GMP demands to
ensure the medicine produced is safe for patients.
GMP consideration are vital in all design phases.
From early conceptual design to the
implementation and execution of pharmaceutical
quality systems.
6/16/2021 4
5. Pharmacy Informatics
Application of IT systems in Pharmaceutical industry
is called as PHARMACY INFORMATICS
The scientific field that deals with biomedical
information, data and knowledge – their storage,
retrieval and optimal use for problem solving and
decision-making.
It is tightly focused on the optimal use of drug
information for problem-solving, decision making and
promoting safe pharmaceutical care.
6/16/2021 5
6. Importance in Pharma Industry
Preventing medication errors
To interconnect clinicians
Decrease the manual work
To smoothen the work- flow
To develop strict security and to reduce paper work
(e-documentation and e-marketing)
Complete automation of manufacturing, accounting
and distribution processes.
6/16/2021 6
7. Role in Medical Store Management
Pharmacy management software help pharmacist:
Help pharmacist to manage Purchase.
Help pharmacist to manage Purchase return.
Help pharmacist to manage Sale.
Help pharmacist to manage Sale return.
Help pharmacist to manage Short items.
Help pharmacist to manage expiry date product
effectively.
Pharmacy management software are fully automated
which will help reduce the burden of the pharmacist
and increase revenue.
6/16/2021 7
8. Top 10 Popular Medical Store Software
• Marg Chemist Software
• PharmSoft
• Medica
• Pharmiz
• Visual Chemist
• LogicPharma
• CBO
• Clinicea
• hCue
• Gofrugal
6/16/2021 8
9. Role in Hospital Pharmacy
Computerized Physician Order Entry (CPOE)
Include both inpatient orders and the electronic ordering
of outpatient prescriptions often referred to as e-
prescribing.
Allows physicians & other caregivers input orders directly
into a computer, thereby eliminating problems with
handwriting legibility and order transcription.
Physician can make good clinical decisions based on e-
records of patients.
Bar-coded medication administration: System alerts the
nurse to any mismatch of patient identity or of the name,
dose, or route of administration of the medication.
6/16/2021 9
13. CPOE helps in
• Order entry into the pharmacy information
system.
• Online order verification by pharmacist
• Computerized warnings for drug allergies.
• Inappropriate doses.
• Drug-drug interactions.
• Computer-supported medication supply and
distribution.
• Automated label generation.
• Computerized pharmacy billing.
6/16/2021 13
15. Role in Pharmaceutical Industry
1. Management of data:
Enterprise Resource Planning (ERP):
An ERP system integrates all data and processes of
an organization.
The purpose of ERP is to facilitate the flow of
information between all business functions inside
the boundaries of the organization and manage the
connections to outside stakeholders.
6/16/2021 15
16. ERP consists of various modules
• Production and inventory management
• Weighing and dispensing
• E-batch records
• E-packaging records
• Financial accounting
• Personnel management
• Training and development
6/16/2021 16
17. 2. Management of laboratory information:
Laboratory Information Management System (LIMS)
• It manages the information flow within the lab and
can be the modus operandi of connecting the lab with
the rest of the organization.
• Automates lab processes to increase productivity,
efficiency and quality in analysis.
• More important is that, it takes care of 70% of
laboratory guidelines, what we called as GLP
6/16/2021 17
Role in Pharmaceutical Industry
18. It helps from:
• Sample request to sample registration
• Sample collection
• Automatic calculations of tests methods
• Specification maintenance
• Assigning properties to those tests
• Recording results, generating reports
• Issuing COA’s (Certificate of Analysis)
6/16/2021 18
19. 3. Customer Relationship Management (CRM)
Sales Force Automation (SFA) Software
• SFA are information systems used in CRM that helps to
automate some sales and sales management functions.
• It is a system that automatically records all the stages in a
sales process.
• It manages data, controls on-line movement of goods and
manpower, including distribution network for pharmaceutical
marketing
6/16/2021 19
Role in Pharmaceutical Industry
20. It automates all the areas starting from
• On-line records
• Doctor visit reports
• Tour plans and approvals,
• Sales summaries & Booking sales orders
• Expense details & stockiest inventory
6/16/2021 20
21. 4. Management of manufacturing and packing records
Electronic Batch Records (EBR) Software
• It is a software for on-line management of batch
manufacturing and packaging records.
• It converts the bulky documentation work into very
centralized automatic version.
• EBR aggregates data from across various departments and
summarizes it into one consolidated record for the lot
produced.
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Role in Pharmaceutical Industry
22. It performs following functions
• Secured document management
• Checks data integrity
• Performs automatic calculations
• Automatic audit trail
• Other control measures to help ensure compliance with
21 Cost and Freight (CFR) Part 11 regulation.
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23. 1. Drug Discovery
Drug Design:
A) Target protein structure prediction
B) Drug protein interaction study
Drug Screening
A) Bioactivity predication
B) Toxicity predication
C) Physicochemical properties predication
2. Pharmaceutical product development
A) Aid in deciding suitable exceptions
B) Monitoring and modifying development process
C) Ensuring in-process specification compliance
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Role in Research and Development
24. 3. Pharmaceutical manufacturing
A) Automated manufacturing
B) Correlating manufacturing errors to set parameters
C) Personalized manufacturing
4. Quality Assurance and Quality Control
A) Understanding critical process parameter
B) Guide future production cycle
C) Regulation of in-line quality
D) Ensure QA with aid of Electronic Laboratory Notebook (ELN)
and other techniques
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Role in Research and Development
25. 5. Clinical trail design and monitoring
A) Subject enrollment or selection
B) Patient drop out
C) Monitoring of trails
6. Pharmaceutical product management
A) Market positioning
B) Market prediction and analysis
C) Product coasting
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Role in Research and Development
26. Some of the software use in pharmaceuticals
Research & Development
• ChemDraw: With its origins as a chemical drawing tool,
ChemDraw has evolved steadily to become the leading
chemically-intelligent solution for multiple disciplines from
specialty chemistry to pharmaceutical drug discovery.
• AutoDock: It is designed to predict how small molecules,
such as substrates or drug candidates, bind to a receptor of
known 3D structure.
• CDD Vault: It helps project team manage, analyze and
present chemical structures and biological assay data.
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27. • adWATCH: Helps pharmaceutical organizations manage and
report adverse events that occur during clinical trials.
• Virtual Labs: Initiative by Ministry of Education, Government
of India with an aim to provide remote-access to Labs in
various disciplines of Science and Engineering.
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28. Summary
To sum up…
• High competition, less time to reach the market and a
highly regulated environment have forced Indian
pharma companies to adopt advanced and latest IT
and automation solutions.
• In the recent years, there has been a significant rise
in the use of computer related systems in the
pharma industry.
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29. • Many industries have got most of their operations
computerized.
• Not just the big pharma companies, but even about
70% of the small and medium enterprises utilize
automation in one form or the other.
• Software systems are being increasingly accepted
as an essential part of a modern and progressive
pharma industry.
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Summary (Continue….)