The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
Introduction to Regulatory Affairs - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, June 14, our colleagues Fiorenzo Savoretti, Senior Regulatory and Quality Consultant at Pfizer and Nick Deschacht, Senior RA Consultant at GSK, gave an interesting “Introduction to Regulatory Affairs”.
Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
The dossier is a collection of documents that contain all the technical data of pharmaceutical products to be approved\ registered\ marketed in a country.
Introduction to Regulatory Affairs - Pauwels Consulting AcademyPauwels Consulting
On Tuesday, June 14, our colleagues Fiorenzo Savoretti, Senior Regulatory and Quality Consultant at Pfizer and Nick Deschacht, Senior RA Consultant at GSK, gave an interesting “Introduction to Regulatory Affairs”.
Fiorenzo and Nick talked about RA and their projects, each from their unique angle. They delivered their presentations for ## attendees at our Brussels office at the Lambroekstraat 5a in Diegem.
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.
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
Best Practices - Injectable Packaging LinesManish Bhatkar
In the past couple of years we have seen many companies recalling sterile products, primarily due to the problems related to particulate matter and/ or sterility assurance. These problems are not only a potential threat to the patient health, but also lead to short supply due to contamination, manufacturing problems, or product discontinuation. Sterile dosage forms are vulnerable to both microbial and particulate contamination, which has been traced to glass and packaging materials, problems such as leaching and sorption and moreover the manufacturing/ operating practices.
Recently, in an industry workshop I had shared my thoughts, views, experiences and study findings on this topic and I am happy to share the same with you. I hope this will be useful…
Training in a CGMP environment is very important as it is a very important requirement of the regulations. Training is simply one of the means to fill the gaps of performance between the actual results and the expected results.
Food Safety Modernization Act (FSMA) regulatory requirements by FDABrian Thomas
Food Safety Modernization Act (FSMA) is placing new regulatory demands on food manufacturers and suppliers in the US market. For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. As key implementation deadlines approach, food manufacturers are shifting from a reactionary to a preventive footing, with stricter controls, documentation, and supplier verification requirements. This means there is a new regulatory world for food producers, including regulations for food-borne illness prevention and traceability. Presentation provides a summary of the new regulations, the risks and challenges faced by food producers, and the opportunities to take action through applications of modern control and information technology.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatorz Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
TGA Presentation: GMP Clearance Information Session,5-7 September 2017TGA Australia
Provides an overview of the improvements made to the GMP clearance process including the revised guidance, the introduction of an application assistance tool, the redesigned application e-forms and the compliance verification process.
This presentation details the overall scenario of the pharmaceutical sector in India as well as the state of Gujarat. The presentation highlights the investment & business opportunities present in the sector owing to the robust growth of the sector in India as well as Gujarat. Various government assistance schemes & incentives further augment the business potential of the sector.
May 2015 Edition of BEACON, A Monthly Newsletter by SIMCON.
Inside this issue:
About Us
Our Team
INDUSTRY ANALYSIS : Pharmaceutical Industry
COMPANY ANALYSIS : Sun Pharma
BRAND ANALYSIS : Kellogg's
Concept of the month
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.
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
Best Practices - Injectable Packaging LinesManish Bhatkar
In the past couple of years we have seen many companies recalling sterile products, primarily due to the problems related to particulate matter and/ or sterility assurance. These problems are not only a potential threat to the patient health, but also lead to short supply due to contamination, manufacturing problems, or product discontinuation. Sterile dosage forms are vulnerable to both microbial and particulate contamination, which has been traced to glass and packaging materials, problems such as leaching and sorption and moreover the manufacturing/ operating practices.
Recently, in an industry workshop I had shared my thoughts, views, experiences and study findings on this topic and I am happy to share the same with you. I hope this will be useful…
Training in a CGMP environment is very important as it is a very important requirement of the regulations. Training is simply one of the means to fill the gaps of performance between the actual results and the expected results.
Food Safety Modernization Act (FSMA) regulatory requirements by FDABrian Thomas
Food Safety Modernization Act (FSMA) is placing new regulatory demands on food manufacturers and suppliers in the US market. For the first time, FDA has a legislative mandate to require comprehensive, prevention-based controls across the food supply. As key implementation deadlines approach, food manufacturers are shifting from a reactionary to a preventive footing, with stricter controls, documentation, and supplier verification requirements. This means there is a new regulatory world for food producers, including regulations for food-borne illness prevention and traceability. Presentation provides a summary of the new regulations, the risks and challenges faced by food producers, and the opportunities to take action through applications of modern control and information technology.
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatorz Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
TGA Presentation: GMP Clearance Information Session,5-7 September 2017TGA Australia
Provides an overview of the improvements made to the GMP clearance process including the revised guidance, the introduction of an application assistance tool, the redesigned application e-forms and the compliance verification process.
This presentation details the overall scenario of the pharmaceutical sector in India as well as the state of Gujarat. The presentation highlights the investment & business opportunities present in the sector owing to the robust growth of the sector in India as well as Gujarat. Various government assistance schemes & incentives further augment the business potential of the sector.
May 2015 Edition of BEACON, A Monthly Newsletter by SIMCON.
Inside this issue:
About Us
Our Team
INDUSTRY ANALYSIS : Pharmaceutical Industry
COMPANY ANALYSIS : Sun Pharma
BRAND ANALYSIS : Kellogg's
Concept of the month
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.
Opportunities of BDS in Pharmaceutical Industries.pptxDr. Manoj Kumbhare
India is the second-largest pharmaceutical market in Asia. ... A BDS graduate can have various job roles available in this sector: Principal Investigator, Co-investigator, Medical Advisor, Drug Developer, Regulatory Affairs Manager or even a Clinical Research Physician.
Career opportunities in the clinical research field are many and varied, with employment settings ranging from pharmaceutical and biotechnology, to medical device companies, contract research organizations, hospitals, educational institutions, independent contractors and more.
Many professionals with a strong science or healthcare related background — such as nurses, pharmacists, medical technologists, physicians and more — are well-positioned to join the clinical research field. Here are 10 career paths in the field.
Currently, India is one of the top countries where clinical research companies are planning to invest over the next 5-6 years. The Indian government had also proposed a 10-year Tax Holiday on R&D investments – a move to attract more Global Sponsors from the Clinical Research Industry. India has also become the favoured destination ahead of other competing countries like Israel, Philippines, Canada, China, Ireland & Russia in terms of Overall Climate (Gartner Report, January 2003). The Indian sub-continent is also a powerhouse in research and development boasting of over 80 experienced CROs offering services from Phase I to IV trials. With 4,216 hospitals and rapidly increasing stand-alone investigators serving at sites for clinical trials, India is emerging as one of the fastest recruiters of subjects across the world. The large patient pool is also a significant contributor towards achieving these milestones.
A new set of rules in place since 2019 is beginning to make India the favourite among the big pharma giants to conduct clinical trials in India. India ranks among top five destinations for clinical trial sites and numerous big global studies are now being carried out in India – especially post the Covid pandemic. In 2021, India approved over 100 global clinical trials, this being the highest number since 2013. India has also enacted the New Drugs and Clinical Trials (NDCT) rules in March 2019 wherein a lot of accommodation is being provided to enrich the clinical research activities in the country. One of the prime reasons for global attraction is quality services at reduced costs. India is still 60% cheaper than the U.S. when it comes to conducting end-to-end clinical trials. India also has numerous world class hospitals as trial sites: 1,762 sites and counting. Also, it is equipped with about 4000+ ICH-GCP trained investigators.
Project on Production and Packaging in Pharmaceutical Industry Emcure By Nikh...Nikhil Dhawan
This is the Complete Project that I`ve Completed on 7/08/2014 and It is Now Brand New Project Report Suitable for Students doing MBA, PGDBM and Having Topics like Marketing or HR. No Ads, No Price, No Money!
You Can Contact Me for More Free Projects! Just Download the Project and Enjoy! Cheers!!
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Nikhil Dhawan
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SYNCRETIC CLINICAL RESEARCH SERVICES PVT. LTD., is an ISO-certified CRO hybrid providing excellent end-to-end clinical research services across all domains since 2014. We have successfully completed multiple trials in various therapeutic areas for both Indian and Global Sponsors.
How to Make a Field invisible in Odoo 17Celine George
It is possible to hide or invisible some fields in odoo. Commonly using “invisible” attribute in the field definition to invisible the fields. This slide will show how to make a field invisible in odoo 17.
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.
Embracing GenAI - A Strategic ImperativePeter Windle
Artificial Intelligence (AI) technologies such as Generative AI, Image Generators and Large Language Models have had a dramatic impact on teaching, learning and assessment over the past 18 months. The most immediate threat AI posed was to Academic Integrity with Higher Education Institutes (HEIs) focusing their efforts on combating the use of GenAI in assessment. Guidelines were developed for staff and students, policies put in place too. Innovative educators have forged paths in the use of Generative AI for teaching, learning and assessments leading to pockets of transformation springing up across HEIs, often with little or no top-down guidance, support or direction.
This Gasta posits a strategic approach to integrating AI into HEIs to prepare staff, students and the curriculum for an evolving world and workplace. We will highlight the advantages of working with these technologies beyond the realm of teaching, learning and assessment by considering prompt engineering skills, industry impact, curriculum changes, and the need for staff upskilling. In contrast, not engaging strategically with Generative AI poses risks, including falling behind peers, missed opportunities and failing to ensure our graduates remain employable. The rapid evolution of AI technologies necessitates a proactive and strategic approach if we are to remain relevant.
Palestine last event orientationfvgnh .pptxRaedMohamed3
An EFL lesson about the current events in Palestine. It is intended to be for intermediate students who wish to increase their listening skills through a short lesson in power point.
2024.06.01 Introducing a competency framework for languag learning materials ...Sandy Millin
http://sandymillin.wordpress.com/iateflwebinar2024
Published classroom materials form the basis of syllabuses, drive teacher professional development, and have a potentially huge influence on learners, teachers and education systems. All teachers also create their own materials, whether a few sentences on a blackboard, a highly-structured fully-realised online course, or anything in between. Despite this, the knowledge and skills needed to create effective language learning materials are rarely part of teacher training, and are mostly learnt by trial and error.
Knowledge and skills frameworks, generally called competency frameworks, for ELT teachers, trainers and managers have existed for a few years now. However, until I created one for my MA dissertation, there wasn’t one drawing together what we need to know and do to be able to effectively produce language learning materials.
This webinar will introduce you to my framework, highlighting the key competencies I identified from my research. It will also show how anybody involved in language teaching (any language, not just English!), teacher training, managing schools or developing language learning materials can benefit from using the framework.
Welcome to TechSoup New Member Orientation and Q&A (May 2024).pdfTechSoup
In this webinar you will learn how your organization can access TechSoup's wide variety of product discount and donation programs. From hardware to software, we'll give you a tour of the tools available to help your nonprofit with productivity, collaboration, financial management, donor tracking, security, and more.
The French Revolution, which began in 1789, was a period of radical social and political upheaval in France. It marked the decline of absolute monarchies, the rise of secular and democratic republics, and the eventual rise of Napoleon Bonaparte. This revolutionary period is crucial in understanding the transition from feudalism to modernity in Europe.
For more information, visit-www.vavaclasses.com
Instructions for Submissions thorugh G- Classroom.pptxJheel Barad
This presentation provides a briefing on how to upload submissions and documents in Google Classroom. It was prepared as part of an orientation for new Sainik School in-service teacher trainees. As a training officer, my goal is to ensure that you are comfortable and proficient with this essential tool for managing assignments and fostering student engagement.
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
The Roman Empire A Historical Colossus.pdfkaushalkr1407
The Roman Empire, a vast and enduring power, stands as one of history's most remarkable civilizations, leaving an indelible imprint on the world. It emerged from the Roman Republic, transitioning into an imperial powerhouse under the leadership of Augustus Caesar in 27 BCE. This transformation marked the beginning of an era defined by unprecedented territorial expansion, architectural marvels, and profound cultural influence.
The empire's roots lie in the city of Rome, founded, according to legend, by Romulus in 753 BCE. Over centuries, Rome evolved from a small settlement to a formidable republic, characterized by a complex political system with elected officials and checks on power. However, internal strife, class conflicts, and military ambitions paved the way for the end of the Republic. Julius Caesar’s dictatorship and subsequent assassination in 44 BCE created a power vacuum, leading to a civil war. Octavian, later Augustus, emerged victorious, heralding the Roman Empire’s birth.
Under Augustus, the empire experienced the Pax Romana, a 200-year period of relative peace and stability. Augustus reformed the military, established efficient administrative systems, and initiated grand construction projects. The empire's borders expanded, encompassing territories from Britain to Egypt and from Spain to the Euphrates. Roman legions, renowned for their discipline and engineering prowess, secured and maintained these vast territories, building roads, fortifications, and cities that facilitated control and integration.
The Roman Empire’s society was hierarchical, with a rigid class system. At the top were the patricians, wealthy elites who held significant political power. Below them were the plebeians, free citizens with limited political influence, and the vast numbers of slaves who formed the backbone of the economy. The family unit was central, governed by the paterfamilias, the male head who held absolute authority.
Culturally, the Romans were eclectic, absorbing and adapting elements from the civilizations they encountered, particularly the Greeks. Roman art, literature, and philosophy reflected this synthesis, creating a rich cultural tapestry. Latin, the Roman language, became the lingua franca of the Western world, influencing numerous modern languages.
Roman architecture and engineering achievements were monumental. They perfected the arch, vault, and dome, constructing enduring structures like the Colosseum, Pantheon, and aqueducts. These engineering marvels not only showcased Roman ingenuity but also served practical purposes, from public entertainment to water supply.
Acetabularia Information For Class 9 .docxvaibhavrinwa19
Acetabularia acetabulum is a single-celled green alga that in its vegetative state is morphologically differentiated into a basal rhizoid and an axially elongated stalk, which bears whorls of branching hairs. The single diploid nucleus resides in the rhizoid.
1. (Department of Applied Pharmaceuticals)
Indian Biosciences and Research Institute
IBRI NOIDA
2. India is now among the top five pharmaceutical
emerging markets.
The Indian Pharma industry has been growing at a
compounded annual growth rate (CAGR) of more
than 15% over the last five years and has significant
growth opportunities.
The Ministry of Commerce has targeted Indian Pharma
sector exports at US$ 25 billion by 2014 at an annual
growth rate of 25 per cent.
IBRI NOIDA
3. FDI, up to 100 per cent, under the automatic route,
would continue to be permitted for Greenfield
investments in the Pharmaceuticals sector.
In order to encourage production of drugs by
indigenous industries, the 12th Five Year Plan (2012-17)
has recommended capacity building of private sector to
meet WHO-GMP standards and other international
manufacturing standards.
IBRI NOIDA
4. A regular student of Pharmacy B.Pharma, M.Pharma.
A working professional in Pharmaceutical Industry.
Research scholars' in the same domain.
IBRI NOIDA
5. 12 months comprehensive course in distance mode
learning pattern.
6 months advanced course in distance mode learning
only for working professionals.
3 months certificate course for beginners.
IBRI NOIDA
6. Most updated course material
Course material prepared by highly experienced
professional from the globe.
Effective learning process.
Excellent student support for best service.
Industry Recognized Course.
Coast effective.
IBRI NOIDA
7. Course contains 7 Papers as
Paper-I: Introduction to Regulatory Affairs and Profession
Paper-II: International Licensing and Drug Regulatory Affairs
Paper-III: Regulatory Documentation for Biologics /Medical
Diagnostics and Pharmaceutics (Submission of DMF, Dossiers etc.)
Paper-IV: Global Regulatory Compliance Systems
Paper-V: Regulations for Clinical Trials, GMP, GLP and ICH
Guidelines
Paper-VI: Regulatory Strategy and Quality Assurance Systems
Paper-VII: Future of Biopharmaceuticals
IBRI NOIDA
8. Download Registration Form
Fill it completely
Attach your 10th and graduation mark sheet
photocopies self attested.
Course fee can be paid by Demand Draft / At par
Cheque.
DD or At par Cheque must be in favor of “Indian
Biosciences and Research Institute”.
Attach all with registration form and send it to institute
address
IBRI NOIDA
9. Complete Study Material will be dispatched to your
mailing address.
Bimonthly assignments for self assessment.
Contact classes on the demand to clear doubts.
Weekly conversation with faculty members.
Examination and assessment.
Successful candidates will received Certificate and
mark sheet.
IBRI NOIDA
10. Regulatory Affairs is a comparatively new profession which has
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.
The Regulatory Affairs professional’s job is to keep track of the
ever-changing legislation in all the regions in which the
company wishes to distribute its products. With the aim of
providing training IBRI has launched the course in Regulatory
affairs with the mission to train students and professionals who
can help the industry to work under regulatory environment.
IBRI NOIDA
11. TO KNOW MORE Click Here !
Indian Biosciences and Research Institute
C 50, Sector 2, NOIDA 201301
IBRI NOIDA
12. Indian Biosciences and Research Institute
C 50, Sector 2, NOIDA 201301
www.ibri.org.in, info@ibri.org.in
Phone: 0120-4122315
Mob: 9999509892
IBRI NOIDA