Strategic decision making in pharmacological companies.
Techno managerial aspects in pharmacological companies.
Regulations of biotechnological products
Regulatory affairs in Pharmaceutical IndustryRama Shukla
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.
IPhVC recommendations & monitoring requirement of biosimilars, Worldwide & Iraq control of Bioproducts & biosimiliars, as well as references enlisted adverse reactions to common products used in our hospital
Lecture presented at the 31st Jan 2024 in our hospital
A recap and summary of the two day course, covering:
• Medical devices and diagnostics
• Industrial applications and CleanTech
• Aquaculture
• Agriculture
• Further reading and resources
Regulatory affairs in Pharmaceutical IndustryRama Shukla
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.
IPhVC recommendations & monitoring requirement of biosimilars, Worldwide & Iraq control of Bioproducts & biosimiliars, as well as references enlisted adverse reactions to common products used in our hospital
Lecture presented at the 31st Jan 2024 in our hospital
A recap and summary of the two day course, covering:
• Medical devices and diagnostics
• Industrial applications and CleanTech
• Aquaculture
• Agriculture
• Further reading and resources
The data is written in very easy and convinient method that the reader can easily digest the content.Data provided is based on search works including information in written form as well in the form of flow chart diagrams that provides a way to understand the content for longer time.
These slides have all the basic knowledge about the role of biotechnology in our daily lives includin pharma science,cosmatics,food science,agriculture and more importantly about vaccine and covid -19.How vaccine works.How Biotechnology played its part.
Socioeconomic considerations, biosafety and decision making: The view of a pr...Jose Falck Zepeda
"Socioeconomic considerations, biosafety and decision making: The view of a practitioner” is a presentation I made at the Michigan State University 2013 short course on environmental biosafety, August 8 2013. The focus is on socioeconomic considerations, biosafety and decision making highlighting issues, options and approaches to such inclusion from a developing country perspective.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
Canadian Regulatory Aspects of Gene Editing Technologies - Christine TibeliusOECD Environment
This presentation addresses the regulatory questions associated with genome editing applications in agriculture in Canada, with a view to discussing approaches to address them.
Biotechnology for Health and Food Security [Najat Mokhtar, Hassan II Academy ...UNESCO Venice Office
Workshop on Higher Education and Professional Responsibility in CBRN Applied Sciences and Technology across the Sub-Mediterranean Region
3-4 April 2012. Palazzo Zorzi, Venice
Session 2. Science and Society - Identifying Priorities and New Technologies Challenges
Presentation about Biosimilars on Save Your Skin Foundation webinar, January 19, 2018. This is presentation #1 of 3 in the webinar: 1. Health Canada 2. CADTH 3. Louise Binder, Save Your Skin Fdn.
Pushing the limits of ePRTC: 100ns holdover for 100 daysAdtran
At WSTS 2024, Alon Stern explored the topic of parametric holdover and explained how recent research findings can be implemented in real-world PNT networks to achieve 100 nanoseconds of accuracy for up to 100 days.
The data is written in very easy and convinient method that the reader can easily digest the content.Data provided is based on search works including information in written form as well in the form of flow chart diagrams that provides a way to understand the content for longer time.
These slides have all the basic knowledge about the role of biotechnology in our daily lives includin pharma science,cosmatics,food science,agriculture and more importantly about vaccine and covid -19.How vaccine works.How Biotechnology played its part.
Socioeconomic considerations, biosafety and decision making: The view of a pr...Jose Falck Zepeda
"Socioeconomic considerations, biosafety and decision making: The view of a practitioner” is a presentation I made at the Michigan State University 2013 short course on environmental biosafety, August 8 2013. The focus is on socioeconomic considerations, biosafety and decision making highlighting issues, options and approaches to such inclusion from a developing country perspective.
USFDA Approval Process For Drug Products & Biological Product i.e NDA Vs. BLA
Comparison of NDA and BLA application process in USA. IND, NDA, ANDA & BLA dossier submission procedure.
Canadian Regulatory Aspects of Gene Editing Technologies - Christine TibeliusOECD Environment
This presentation addresses the regulatory questions associated with genome editing applications in agriculture in Canada, with a view to discussing approaches to address them.
Biotechnology for Health and Food Security [Najat Mokhtar, Hassan II Academy ...UNESCO Venice Office
Workshop on Higher Education and Professional Responsibility in CBRN Applied Sciences and Technology across the Sub-Mediterranean Region
3-4 April 2012. Palazzo Zorzi, Venice
Session 2. Science and Society - Identifying Priorities and New Technologies Challenges
Presentation about Biosimilars on Save Your Skin Foundation webinar, January 19, 2018. This is presentation #1 of 3 in the webinar: 1. Health Canada 2. CADTH 3. Louise Binder, Save Your Skin Fdn.
Pushing the limits of ePRTC: 100ns holdover for 100 daysAdtran
At WSTS 2024, Alon Stern explored the topic of parametric holdover and explained how recent research findings can be implemented in real-world PNT networks to achieve 100 nanoseconds of accuracy for up to 100 days.
SAP Sapphire 2024 - ASUG301 building better apps with SAP Fiori.pdfPeter Spielvogel
Building better applications for business users with SAP Fiori.
• What is SAP Fiori and why it matters to you
• How a better user experience drives measurable business benefits
• How to get started with SAP Fiori today
• How SAP Fiori elements accelerates application development
• How SAP Build Code includes SAP Fiori tools and other generative artificial intelligence capabilities
• How SAP Fiori paves the way for using AI in SAP apps
GraphSummit Singapore | The Future of Agility: Supercharging Digital Transfor...Neo4j
Leonard Jayamohan, Partner & Generative AI Lead, Deloitte
This keynote will reveal how Deloitte leverages Neo4j’s graph power for groundbreaking digital twin solutions, achieving a staggering 100x performance boost. Discover the essential role knowledge graphs play in successful generative AI implementations. Plus, get an exclusive look at an innovative Neo4j + Generative AI solution Deloitte is developing in-house.
Transcript: Selling digital books in 2024: Insights from industry leaders - T...BookNet Canada
The publishing industry has been selling digital audiobooks and ebooks for over a decade and has found its groove. What’s changed? What has stayed the same? Where do we go from here? Join a group of leading sales peers from across the industry for a conversation about the lessons learned since the popularization of digital books, best practices, digital book supply chain management, and more.
Link to video recording: https://bnctechforum.ca/sessions/selling-digital-books-in-2024-insights-from-industry-leaders/
Presented by BookNet Canada on May 28, 2024, with support from the Department of Canadian Heritage.
Why You Should Replace Windows 11 with Nitrux Linux 3.5.0 for enhanced perfor...SOFTTECHHUB
The choice of an operating system plays a pivotal role in shaping our computing experience. For decades, Microsoft's Windows has dominated the market, offering a familiar and widely adopted platform for personal and professional use. However, as technological advancements continue to push the boundaries of innovation, alternative operating systems have emerged, challenging the status quo and offering users a fresh perspective on computing.
One such alternative that has garnered significant attention and acclaim is Nitrux Linux 3.5.0, a sleek, powerful, and user-friendly Linux distribution that promises to redefine the way we interact with our devices. With its focus on performance, security, and customization, Nitrux Linux presents a compelling case for those seeking to break free from the constraints of proprietary software and embrace the freedom and flexibility of open-source computing.
Epistemic Interaction - tuning interfaces to provide information for AI supportAlan Dix
Paper presented at SYNERGY workshop at AVI 2024, Genoa, Italy. 3rd June 2024
https://alandix.com/academic/papers/synergy2024-epistemic/
As machine learning integrates deeper into human-computer interactions, the concept of epistemic interaction emerges, aiming to refine these interactions to enhance system adaptability. This approach encourages minor, intentional adjustments in user behaviour to enrich the data available for system learning. This paper introduces epistemic interaction within the context of human-system communication, illustrating how deliberate interaction design can improve system understanding and adaptation. Through concrete examples, we demonstrate the potential of epistemic interaction to significantly advance human-computer interaction by leveraging intuitive human communication strategies to inform system design and functionality, offering a novel pathway for enriching user-system engagements.
UiPath Test Automation using UiPath Test Suite series, part 5DianaGray10
Welcome to UiPath Test Automation using UiPath Test Suite series part 5. In this session, we will cover CI/CD with devops.
Topics covered:
CI/CD with in UiPath
End-to-end overview of CI/CD pipeline with Azure devops
Speaker:
Lyndsey Byblow, Test Suite Sales Engineer @ UiPath, Inc.
Observability Concepts EVERY Developer Should Know -- DeveloperWeek Europe.pdfPaige Cruz
Monitoring and observability aren’t traditionally found in software curriculums and many of us cobble this knowledge together from whatever vendor or ecosystem we were first introduced to and whatever is a part of your current company’s observability stack.
While the dev and ops silo continues to crumble….many organizations still relegate monitoring & observability as the purview of ops, infra and SRE teams. This is a mistake - achieving a highly observable system requires collaboration up and down the stack.
I, a former op, would like to extend an invitation to all application developers to join the observability party will share these foundational concepts to build on:
GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using Deplo...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Alt. GDG Cloud Southlake #33: Boule & Rebala: Effective AppSec in SDLC using ...James Anderson
Effective Application Security in Software Delivery lifecycle using Deployment Firewall and DBOM
The modern software delivery process (or the CI/CD process) includes many tools, distributed teams, open-source code, and cloud platforms. Constant focus on speed to release software to market, along with the traditional slow and manual security checks has caused gaps in continuous security as an important piece in the software supply chain. Today organizations feel more susceptible to external and internal cyber threats due to the vast attack surface in their applications supply chain and the lack of end-to-end governance and risk management.
The software team must secure its software delivery process to avoid vulnerability and security breaches. This needs to be achieved with existing tool chains and without extensive rework of the delivery processes. This talk will present strategies and techniques for providing visibility into the true risk of the existing vulnerabilities, preventing the introduction of security issues in the software, resolving vulnerabilities in production environments quickly, and capturing the deployment bill of materials (DBOM).
Speakers:
Bob Boule
Robert Boule is a technology enthusiast with PASSION for technology and making things work along with a knack for helping others understand how things work. He comes with around 20 years of solution engineering experience in application security, software continuous delivery, and SaaS platforms. He is known for his dynamic presentations in CI/CD and application security integrated in software delivery lifecycle.
Gopinath Rebala
Gopinath Rebala is the CTO of OpsMx, where he has overall responsibility for the machine learning and data processing architectures for Secure Software Delivery. Gopi also has a strong connection with our customers, leading design and architecture for strategic implementations. Gopi is a frequent speaker and well-known leader in continuous delivery and integrating security into software delivery.
Communications Mining Series - Zero to Hero - Session 1DianaGray10
This session provides introduction to UiPath Communication Mining, importance and platform overview. You will acquire a good understand of the phases in Communication Mining as we go over the platform with you. Topics covered:
• Communication Mining Overview
• Why is it important?
• How can it help today’s business and the benefits
• Phases in Communication Mining
• Demo on Platform overview
• Q/A
Essentials of Automations: The Art of Triggers and Actions in FMESafe Software
In this second installment of our Essentials of Automations webinar series, we’ll explore the landscape of triggers and actions, guiding you through the nuances of authoring and adapting workspaces for seamless automations. Gain an understanding of the full spectrum of triggers and actions available in FME, empowering you to enhance your workspaces for efficient automation.
We’ll kick things off by showcasing the most commonly used event-based triggers, introducing you to various automation workflows like manual triggers, schedules, directory watchers, and more. Plus, see how these elements play out in real scenarios.
Whether you’re tweaking your current setup or building from the ground up, this session will arm you with the tools and insights needed to transform your FME usage into a powerhouse of productivity. Join us to discover effective strategies that simplify complex processes, enhancing your productivity and transforming your data management practices with FME. Let’s turn complexity into clarity and make your workspaces work wonders!
Sudheer Mechineni, Head of Application Frameworks, Standard Chartered Bank
Discover how Standard Chartered Bank harnessed the power of Neo4j to transform complex data access challenges into a dynamic, scalable graph database solution. This keynote will cover their journey from initial adoption to deploying a fully automated, enterprise-grade causal cluster, highlighting key strategies for modelling organisational changes and ensuring robust disaster recovery. Learn how these innovations have not only enhanced Standard Chartered Bank’s data infrastructure but also positioned them as pioneers in the banking sector’s adoption of graph technology.
Threats to mobile devices are more prevalent and increasing in scope and complexity. Users of mobile devices desire to take full advantage of the features
available on those devices, but many of the features provide convenience and capability but sacrifice security. This best practices guide outlines steps the users can take to better protect personal devices and information.
GraphSummit Singapore | The Art of the Possible with Graph - Q2 2024Neo4j
Neha Bajwa, Vice President of Product Marketing, Neo4j
Join us as we explore breakthrough innovations enabled by interconnected data and AI. Discover firsthand how organizations use relationships in data to uncover contextual insights and solve our most pressing challenges – from optimizing supply chains, detecting fraud, and improving customer experiences to accelerating drug discoveries.
GraphSummit Singapore | The Art of the Possible with Graph - Q2 2024
Strategic decision making.pptx
1. Strategic decision making; techno-
management aspects; returns on
investment and regulation of
biotechnology based products and
industry
Presented by
Akem Lazare
2. Introduction
• Definition of biotechnology: is the study of biology and
technology i.e exploitation of biological agent on any
component of biology to generate useful products and
services
• It combines other disciplines like Microbiology, Chemistry,
Biochemistry, Genetics, Molecular Biology, Immunology, and
Engineering.
• Its scope can be divided into the following; Medical
biotechnology, Agriculture (both Plant and Animal)
biotechnology, Environmental biotechnology and Industrial
Biotechnology
• All these broad areas involves effective management,
strategic decision making, planning and regulations of
products and industry
3. Strategic decision making in biotechnological
companies
• Definition: It is a process of understanding the interaction
of decisions and their impact upon the organization to gain
an advantage either to remain competitive or survive.
• Decision making is a core function of any drug production
firm as drug production involves a lengthy and expensive
process a timely valid decisions are empirical.
• Every phase of drug production has specific financing
obligation with Phase III being the most expensive and most
drugs candidate have fail in this phase without reaching the
market.
• But with a sound strategic decision such drugs destine to fail
can be stop and prevent the company from losing money
4. Characteristic of a good decision making
• Decisions should be made in a coordinated sequence.
• Decision-making should be viewed as a dynamic process
that changes over time.
• The size of the Company determines how much of the
preparatory work for decision-making can be done in-house
and how much needs to be outsourced.
• despite the need to make optimal decisions while managing
drug pipelines, human judgment rather than any formal
analytical method is used in pharmaceutical companies
5. The need for decisions
• Generally, product development can be organized into two
categories:
• the decisions made within a single developmental project and
• those decisions made in establishing an organizational context
and in planning its projects.
• Both are influenced by
- Access to infos about the science
- Manufacturing issues
- Marketing and financial aspects
- the firm’s internal clinical capabilities
- the ability to internalize critical external knowledge
- selecting prime targets for drug discovery
- focusing limited resources to enhance speed
- breaking down barriers between research and manufacturing
6. Return on investment (ROI)
• They are sets of calculations used by pharmaceutical and
biotechnology companies in evaluating product returns,
guiding decisions on further product development or
terminating programs prior to company losses.
• It evaluate the estimated profit and compares it to cost of
product.
• When combined when with SWOT analysis,
•
• ROI can provide invaluable and comparable insight into the
value of potential projects and products.
7. Biotechnology management
• Definition: Is a systematic way of planning, organizing,
controlling and administering the application of scientific and
engineering principles to process the materials by biological
agents to provide goods and service.
• Good managt in biotechnology is needed to drive national
devt and growth.
• However lack of understanding and adequate support from
the govert poses a challenge
• Legal and ethical issues
• Lack of awareness of biotech from the public
8. The significance and impact of
biotechnology management on the human
• Better quality of food products
• Environmental and economic benefit
• Diagnostics and therapeutics merit
• Vaccine production
• Increase in animal biotechnology
• Agricultural production application
9. Regulation of biotechnological products and
industry
• Biotech techniques make many products, including medical,
agricultural, industrial, consumer and research products.
• In the realm of agriculture, biotech techniques can help in
producing new varieties of plants, animals, and microbes or new
substances derived from these sources.
• Examples of products range from insect-protected and/or
herbicide-resistant crops, to apples that do not readily brown
when sliced, to algae modified to produce biofuels or plastic, to
human and animal vaccines and pharmaceuticals
• Three federal agencies are primarily responsible for
regulating biotechnology products
10. Environmental Protection Agency(EPA)
• The mission of the EPA is protection of human health and the
environment.
• EPA regulates the sale, distribution, use and testing of pesticides
in order to protect health and the environment, regardless of how
the pesticide was made or its mode of action.
• Contaminated lands and toxic sites are cleaned up by potentially
responsible parties and revitalized; and
• Chemicals in the marketplace are reviewed for safety.
• EPA is also responsible for determining the amount of bio
pesticide residues that can safely be in food
11. Food and Drug Administration(FDA)
• is responsible for protecting the public health by ensuring the
safety, efficacy, and security of human and veterinary drugs,
biological products, and medical devices;
• has responsibility for regulating the manufacturing, marketing,
and distribution of tobacco products to protect the public health
and to reduce tobacco use by minors.
• is responsible for advancing the public health by helping to speed
innovations that make medical products more effective, safer, and
more affordable
12. U.S. Department of Agriculture
• The mission of USDA and Animal and Plant Health
Inspection Service (APHIS) is to protect agriculture from
pests and diseases.
• In that role it regulates biotech products that could pose
a risk to plant health.
• USDA also has regulatory oversight over products of
biotech that are included in veterinary biologics, and
ensures that veterinary biologics are pure, safe, potent
and effective.
13. Laws that EPA, FDA, and USDA use to
regulate biotechnology products
• Plant Protection Act (PPA) administered by USDA
• Animal Health Protection Act administered by USDA
• Federal Food, Drug, and Cosmetic Act (FD&C Act)
administered by FDA
• Public Health Service Act (PHS Act) administered by FDA
• Federal Food, Drug and Cosmetic Act (FD&C Act), Section
408 administered by EPA
• Endangered Species Act (ESA administered by EPA and FDA