15. Elki Sollenbring - Uppsala Monitoring Centre
•
5 likes•4,104 views
Wednesday, 20 November, 2013 Latin America Biotherapeutic Conference Day 2
Report
Share
Report
Share
Download to read offline
Recommended
Pharmacovigilance
Pharmacovigilance is the science of detecting adverse effects of pharmaceutical drugs. It became important after the thalidomide incident in the 1960s which caused birth defects. The key goals of pharmacovigilance are to improve patient safety, assess benefits and risks of drugs, and promote their rational use. Individual case safety reports are a primary data source and are collected, processed, and shared using systems like VigiFlow and the global database VigiBase. India established the Pharmacovigilance Programme of India in 2010 to monitor drug safety at a national level through regional centers and collaborations with medical organizations.
Individualization of drug
The document discusses various factors that contribute to inter-individual variability in drug response, including age, body weight, gender, genetics, disease conditions, and drug interactions. Key sources of variability include differences in absorption, distribution, metabolism, and excretion of drugs across patients. Pharmacists can help individualize drug dosing regimens for patients based on an understanding of these sources of variability.
Pharmacovigilance
by Dr. Vishal Pawar
MD Pharmacology
a complete and comprehensive view of Pharmacovigilance around the world and in india
ROLE OF PHARMACOVIGILANCE AGAINST ADVERSE DRUG REACTION
The document discusses the role of pharmacovigilance in monitoring adverse drug reactions (ADRs). It summarizes that pharmacovigilance aims to improve drug safety by identifying ADRs from reported cases and analyzing benefit-risk ratios of medications. Historical drug disasters like thalidomide and sulfanilamide poisonings demonstrated the importance of post-market drug safety monitoring. The document outlines the objectives, reporting process, and future of pharmacovigilance in India including expanding stakeholder reporting and standardizing methodology.
Assignment on pharmacovigilance
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
STATISTICAL METHODS FOR PHARMACOVIGILANCE
A VERY SIMPLIFIED VERSION OF STATISTICAL METHODS FOR PHARMACOVIGILANCE
Prepared for M.Pharm Pharmacology- Clinical Research and Pharmacovigilance
Definition and scope of Pharmacoepidemiology
In these slides I shared the information of definition and scope of pharmacoepidemiology. Types of studies - cohort studies, cross-sectional studies etc.
Pharmacovigilance full information
This document discusses various aspects of pharmacovigilance including its aims, responsibilities, methods, governing bodies, adverse drug reactions, terminology, and international programs. The key goals of pharmacovigilance are to improve patient safety, contribute to benefit-risk assessments of medicines, and ensure their rational use. It involves the detection, assessment, understanding and prevention of adverse drug reactions using methods like spontaneous reporting, cohort event monitoring, and record linkage. Regulatory authorities and the WHO play important roles in governing pharmacovigilance activities globally.
Recommended
Pharmacovigilance
Pharmacovigilance is the science of detecting adverse effects of pharmaceutical drugs. It became important after the thalidomide incident in the 1960s which caused birth defects. The key goals of pharmacovigilance are to improve patient safety, assess benefits and risks of drugs, and promote their rational use. Individual case safety reports are a primary data source and are collected, processed, and shared using systems like VigiFlow and the global database VigiBase. India established the Pharmacovigilance Programme of India in 2010 to monitor drug safety at a national level through regional centers and collaborations with medical organizations.
Individualization of drug
The document discusses various factors that contribute to inter-individual variability in drug response, including age, body weight, gender, genetics, disease conditions, and drug interactions. Key sources of variability include differences in absorption, distribution, metabolism, and excretion of drugs across patients. Pharmacists can help individualize drug dosing regimens for patients based on an understanding of these sources of variability.
Pharmacovigilance
by Dr. Vishal Pawar
MD Pharmacology
a complete and comprehensive view of Pharmacovigilance around the world and in india
ROLE OF PHARMACOVIGILANCE AGAINST ADVERSE DRUG REACTION
The document discusses the role of pharmacovigilance in monitoring adverse drug reactions (ADRs). It summarizes that pharmacovigilance aims to improve drug safety by identifying ADRs from reported cases and analyzing benefit-risk ratios of medications. Historical drug disasters like thalidomide and sulfanilamide poisonings demonstrated the importance of post-market drug safety monitoring. The document outlines the objectives, reporting process, and future of pharmacovigilance in India including expanding stakeholder reporting and standardizing methodology.
Assignment on pharmacovigilance
History and Progress of Pharmacovigilance, Significance of Safety Monitoring, Pharmacovigilance in India And International Aspects, WHO International Drug Monitoring Programme, WHO and Regulatory Terminologies of ADR, Evaluation of Medication Safety, Establishing Pharmacovigilance Centres in Hospitals, Industry and National Programmes Related to Pharmacovigilance, Roles and Responsibilities in Pharmacovigilance, International Non-Proprietary Names for Drugs, International Classification of Diseases, Passive and Active Surveillance, Comparative Observational Studies, Targeted Clinical Investigations and Vaccine Safety Surveillance, Aris G Pharmacovigilance, VigiFlow, Statistical Methods for Evaluating Medication Safety Data
STATISTICAL METHODS FOR PHARMACOVIGILANCE
A VERY SIMPLIFIED VERSION OF STATISTICAL METHODS FOR PHARMACOVIGILANCE
Prepared for M.Pharm Pharmacology- Clinical Research and Pharmacovigilance
Definition and scope of Pharmacoepidemiology
In these slides I shared the information of definition and scope of pharmacoepidemiology. Types of studies - cohort studies, cross-sectional studies etc.
Pharmacovigilance full information
This document discusses various aspects of pharmacovigilance including its aims, responsibilities, methods, governing bodies, adverse drug reactions, terminology, and international programs. The key goals of pharmacovigilance are to improve patient safety, contribute to benefit-risk assessments of medicines, and ensure their rational use. It involves the detection, assessment, understanding and prevention of adverse drug reactions using methods like spontaneous reporting, cohort event monitoring, and record linkage. Regulatory authorities and the WHO play important roles in governing pharmacovigilance activities globally.
Adr ppt
The document provides guidelines for adverse drug reaction (ADR) reporting and statistical methods used for safety data analysis. It defines ADRs and different types of ADR reporting such as spontaneous reporting, expedited reporting, and aggregate reporting. It also describes various pharmacovigilance methods used for ADR reporting including passive and active surveillance. Statistical analysis methods covered include measures of central tendency, variability, and parametric and non-parametric tests. Common scales for assessing ADR causality and severity are also mentioned.
Pharmacy Practice: Managing Formularies
This document discusses principles of managing a formulary system in a healthcare institution. It defines key terms like formulary, formulary system management, and discusses the purpose and objectives of formulary management. It describes the roles of the pharmacy and therapeutics committee and drug review panels in the formulary management process. The document outlines principles for drug selection and formulary maintenance, including considering clinical effectiveness, safety and cost when adding or removing drugs from the formulary.
Pharmacoepidemiology
This document discusses pharmacoepidemiology and provides an overview of key concepts:
- Pharmacoepidemiology is defined as the study of the use and effects of drugs in large populations. It combines principles from clinical pharmacology and epidemiology.
- Several study designs can be used including cohort studies, case-control studies, and case reports. Spontaneous adverse event reporting systems are an important source of pharmacoepidemiology data and can generate hypotheses for further investigation.
- Factors that may prompt a pharmacoepidemiological study include regulatory requirements, assessing drug safety in real-world use, and investigating potential issues identified from pre-marketing studies or spontaneous reports.
Adverse drug reactions
This document discusses adverse drug reactions (ADRs). It begins by defining ADRs according to the WHO as any unintended and noxious response to a drug. It then provides a brief history of notable ADR events. The document goes on to classify ADRs based on factors like onset, type of reaction, and severity. It describes each type of reaction with examples. Finally, it discusses other drug-related concepts like side effects, toxicity, dependence, and teratogenicity.
PPT on Vigiflow, Argus-G and Aris For ADR Reporting
ADR reporting Tools Used In Clinical research and Pharmacovigilance
1 Vigiflow
2 Argus-G
3 Aris
ADRs- Their mechanisms, various ADRs, & role of drugs - by RxVichuZ!! :)
This is my 38th powerpoint..
It deals with the pathophysiological mechanisms involved in ADRs, the roles of drugs involved in specific ADRs(in alphabetical order "A")
In future slides, i will present the remaining ADRs, and causative drugs, in alphabetical order...!
Happy reading!!!
@RxVichu-alwz4uh! :)
drug discovery- clinical development
clinical developments in drug discovery process
varoius phases of clinical trials
Phase I, Phase II, Phase III
Pharmacovigilance
This document discusses pharmacovigilance and adverse drug reactions. It defines an adverse drug reaction and explains that the goal of pharmacovigilance is to detect, understand, and prevent such reactions. It outlines who the key partners are in pharmacovigilance efforts, including governments, health professionals, patients, and WHO. The document also explains the importance of pharmacovigilance, citing examples like the thalidomide disaster and significant costs of adverse drug reactions. It emphasizes that pharmacovigilance is needed to promote rational drug use and ensure public safety and confidence in medical treatments.
Placebo Effect In Clinical Studies
Placebo effect in clinical research is a fascinating and widely researched phenomenon in biomedical research and medicine in general. Presentation is an overview of origins and impact of placebo effect in development of new medicines.
Population pharmacokinetics
This document discusses population pharmacokinetics and analyzing population pharmacokinetic data. It notes that while all humans are alike as a species, there are differences between populations in drug metabolism and responses. These differences are due to genetic variations between racial/ethnic groups. It describes several methods for analyzing population pharmacokinetic data, including NONMEM, which fits concentration data from all subjects simultaneously to estimate population parameters and variances, and standard two-stage methods.
Meta analysis and spontaneous reporting
This document discusses meta-analysis, which is a statistical technique for combining the results of multiple independent studies on a topic to obtain an overall estimate of treatment effect. It defines meta-analysis and outlines its key functions and steps, including performing a literature search, establishing inclusion/exclusion criteria, collecting and analyzing data, and formulating conclusions. The document also compares fixed and random effect models of meta-analysis and discusses guidelines and software used in conducting meta-analyses.
Guidelines For ADR Reporting.pptx
Guidelines of ADR reporting are mentioned. Where to report? How to report? Whom to report? These are the major part of the ppt. Normal people can understand about the drug safety process.
Clinical trials its types and designs
clinical trials- definition
types of clinical trials
various designs of clinical trials such as observational design and intervention design.
HOME MEDICATION REVIEW FOR PHARM D STUDENTS.ppt
hOME MEDICATION REVIEW IS out standing self-employment opportunities with good clinical skills and hand on practice for pharm d students..its well an established program in Australia.
Artificial intelligence in Pharmacovigilance
Artificial intelligence can help improve pharmacovigilance in three key ways:
1) AI can automate repetitive manual tasks like data entry of adverse event reports to improve efficiency.
2) Machine learning algorithms can be trained on large databases of adverse drug reaction reports to help identify new safety signals.
3) AI tools show promise in extracting clinically relevant information from individual case safety reports without human review, reducing the time spent on case processing. However, challenges remain around data quality, costs, and ensuring AI augmentation rather than replacement of human experts.
Spontenous adr reporting
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
Pharmacometrics 2.2.17
Pharmacometrics is the science of using mathematical and statistical methods to characterize and predict the pharmacokinetic and pharmacodynamic behavior of drugs. It aims to improve decision making in drug development and pharmacotherapy. Pharmacometric models integrate pharmacokinetic and pharmacodynamic models to describe the relationship between drug concentration, effect, and patient characteristics. Population pharmacometric modeling is useful for characterizing variability in these parameters between individuals.
Adverse drug reactions attributed to genetic differences
Genetic differences between individuals can lead to variability in responses to drugs and adverse drug reactions. Some key points:
- About 30% of adverse drug reactions may be due to genetic polymorphisms affecting drug metabolism. Enzymes like CYP2D6 play an important role.
- Genes can impact how the body processes and breaks down drugs (pharmacokinetics) and how drugs interact with receptors (pharmacodynamics).
- Single nucleotide polymorphisms are variations in DNA sequences that can alter protein structure and drug responses. They have been linked to prolonged muscle relaxation after cholinergic drugs and hemolytic anemia from antimalarial drugs.
Guidelines on adr reporting
This document provides guidelines for reporting adverse drug reactions (ADRs). It outlines the essential information to include in an ADR report under five sections: (1) patient information including demographics, medical history, and test results; (2) suspected drugs and their details; (3) suspected ADR description, treatment, outcomes, and seriousness; (4) other medications; and (5) reporter information. For a valid report, the mandatory fields that must be included are patient initials, age, gender, reaction details, suspected drug name and dosage, seriousness, and outcomes as well as the reporter's name and date of reporting. Complete information is ideal but at minimum the mandatory fields should be reported.
Peter Hotez, Baylor College of Medicine
Peter Hotez, Baylor College of MedicineInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
30 November 2016, Washington DC
IFPMA Assembly 2016: Global Health V.2.0 Challenges in a Changing WorldSession1: Patrick Deboyser, European Union
Session1: Patrick Deboyser, European UnionInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanMore Related Content
What's hot
Adr ppt
The document provides guidelines for adverse drug reaction (ADR) reporting and statistical methods used for safety data analysis. It defines ADRs and different types of ADR reporting such as spontaneous reporting, expedited reporting, and aggregate reporting. It also describes various pharmacovigilance methods used for ADR reporting including passive and active surveillance. Statistical analysis methods covered include measures of central tendency, variability, and parametric and non-parametric tests. Common scales for assessing ADR causality and severity are also mentioned.
Pharmacy Practice: Managing Formularies
This document discusses principles of managing a formulary system in a healthcare institution. It defines key terms like formulary, formulary system management, and discusses the purpose and objectives of formulary management. It describes the roles of the pharmacy and therapeutics committee and drug review panels in the formulary management process. The document outlines principles for drug selection and formulary maintenance, including considering clinical effectiveness, safety and cost when adding or removing drugs from the formulary.
Pharmacoepidemiology
This document discusses pharmacoepidemiology and provides an overview of key concepts:
- Pharmacoepidemiology is defined as the study of the use and effects of drugs in large populations. It combines principles from clinical pharmacology and epidemiology.
- Several study designs can be used including cohort studies, case-control studies, and case reports. Spontaneous adverse event reporting systems are an important source of pharmacoepidemiology data and can generate hypotheses for further investigation.
- Factors that may prompt a pharmacoepidemiological study include regulatory requirements, assessing drug safety in real-world use, and investigating potential issues identified from pre-marketing studies or spontaneous reports.
Adverse drug reactions
This document discusses adverse drug reactions (ADRs). It begins by defining ADRs according to the WHO as any unintended and noxious response to a drug. It then provides a brief history of notable ADR events. The document goes on to classify ADRs based on factors like onset, type of reaction, and severity. It describes each type of reaction with examples. Finally, it discusses other drug-related concepts like side effects, toxicity, dependence, and teratogenicity.
PPT on Vigiflow, Argus-G and Aris For ADR Reporting
ADR reporting Tools Used In Clinical research and Pharmacovigilance
1 Vigiflow
2 Argus-G
3 Aris
ADRs- Their mechanisms, various ADRs, & role of drugs - by RxVichuZ!! :)
This is my 38th powerpoint..
It deals with the pathophysiological mechanisms involved in ADRs, the roles of drugs involved in specific ADRs(in alphabetical order "A")
In future slides, i will present the remaining ADRs, and causative drugs, in alphabetical order...!
Happy reading!!!
@RxVichu-alwz4uh! :)
drug discovery- clinical development
clinical developments in drug discovery process
varoius phases of clinical trials
Phase I, Phase II, Phase III
Pharmacovigilance
This document discusses pharmacovigilance and adverse drug reactions. It defines an adverse drug reaction and explains that the goal of pharmacovigilance is to detect, understand, and prevent such reactions. It outlines who the key partners are in pharmacovigilance efforts, including governments, health professionals, patients, and WHO. The document also explains the importance of pharmacovigilance, citing examples like the thalidomide disaster and significant costs of adverse drug reactions. It emphasizes that pharmacovigilance is needed to promote rational drug use and ensure public safety and confidence in medical treatments.
Placebo Effect In Clinical Studies
Placebo effect in clinical research is a fascinating and widely researched phenomenon in biomedical research and medicine in general. Presentation is an overview of origins and impact of placebo effect in development of new medicines.
Population pharmacokinetics
This document discusses population pharmacokinetics and analyzing population pharmacokinetic data. It notes that while all humans are alike as a species, there are differences between populations in drug metabolism and responses. These differences are due to genetic variations between racial/ethnic groups. It describes several methods for analyzing population pharmacokinetic data, including NONMEM, which fits concentration data from all subjects simultaneously to estimate population parameters and variances, and standard two-stage methods.
Meta analysis and spontaneous reporting
This document discusses meta-analysis, which is a statistical technique for combining the results of multiple independent studies on a topic to obtain an overall estimate of treatment effect. It defines meta-analysis and outlines its key functions and steps, including performing a literature search, establishing inclusion/exclusion criteria, collecting and analyzing data, and formulating conclusions. The document also compares fixed and random effect models of meta-analysis and discusses guidelines and software used in conducting meta-analyses.
Guidelines For ADR Reporting.pptx
Guidelines of ADR reporting are mentioned. Where to report? How to report? Whom to report? These are the major part of the ppt. Normal people can understand about the drug safety process.
Clinical trials its types and designs
clinical trials- definition
types of clinical trials
various designs of clinical trials such as observational design and intervention design.
HOME MEDICATION REVIEW FOR PHARM D STUDENTS.ppt
hOME MEDICATION REVIEW IS out standing self-employment opportunities with good clinical skills and hand on practice for pharm d students..its well an established program in Australia.
Artificial intelligence in Pharmacovigilance
Artificial intelligence can help improve pharmacovigilance in three key ways:
1) AI can automate repetitive manual tasks like data entry of adverse event reports to improve efficiency.
2) Machine learning algorithms can be trained on large databases of adverse drug reaction reports to help identify new safety signals.
3) AI tools show promise in extracting clinically relevant information from individual case safety reports without human review, reducing the time spent on case processing. However, challenges remain around data quality, costs, and ensuring AI augmentation rather than replacement of human experts.
Spontenous adr reporting
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
Pharmacometrics 2.2.17
Pharmacometrics is the science of using mathematical and statistical methods to characterize and predict the pharmacokinetic and pharmacodynamic behavior of drugs. It aims to improve decision making in drug development and pharmacotherapy. Pharmacometric models integrate pharmacokinetic and pharmacodynamic models to describe the relationship between drug concentration, effect, and patient characteristics. Population pharmacometric modeling is useful for characterizing variability in these parameters between individuals.
Adverse drug reactions attributed to genetic differences
Genetic differences between individuals can lead to variability in responses to drugs and adverse drug reactions. Some key points:
- About 30% of adverse drug reactions may be due to genetic polymorphisms affecting drug metabolism. Enzymes like CYP2D6 play an important role.
- Genes can impact how the body processes and breaks down drugs (pharmacokinetics) and how drugs interact with receptors (pharmacodynamics).
- Single nucleotide polymorphisms are variations in DNA sequences that can alter protein structure and drug responses. They have been linked to prolonged muscle relaxation after cholinergic drugs and hemolytic anemia from antimalarial drugs.
Guidelines on adr reporting
This document provides guidelines for reporting adverse drug reactions (ADRs). It outlines the essential information to include in an ADR report under five sections: (1) patient information including demographics, medical history, and test results; (2) suspected drugs and their details; (3) suspected ADR description, treatment, outcomes, and seriousness; (4) other medications; and (5) reporter information. For a valid report, the mandatory fields that must be included are patient initials, age, gender, reaction details, suspected drug name and dosage, seriousness, and outcomes as well as the reporter's name and date of reporting. Complete information is ideal but at minimum the mandatory fields should be reported.
What's hot (20)
PPT on Vigiflow, Argus-G and Aris For ADR Reporting
PPT on Vigiflow, Argus-G and Aris For ADR Reporting
ADRs- Their mechanisms, various ADRs, & role of drugs - by RxVichuZ!! :)
ADRs- Their mechanisms, various ADRs, & role of drugs - by RxVichuZ!! :)
Adverse drug reactions attributed to genetic differences
Adverse drug reactions attributed to genetic differences
More from International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
Peter Hotez, Baylor College of Medicine
Peter Hotez, Baylor College of MedicineInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
30 November 2016, Washington DC
IFPMA Assembly 2016: Global Health V.2.0 Challenges in a Changing WorldSession1: Patrick Deboyser, European Union
Session1: Patrick Deboyser, European UnionInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 1: Current Regulatory Landscape & Initiatives Against Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanSession 4: Bejon Misra Partnership for Safe Medicines (PSM) INDIA /
Session 4: Bejon Misra Partnership for Safe Medicines (PSM) INDIA / International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanSession 4 Sabine Walser Council of Europe / Legal framework necessary for eff...
Session 4 Sabine Walser Council of Europe / Legal framework necessary for eff...International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanSession 4: Domenico Di Giorgio AIFA Italy / SPOC model cooperation against co...
Session 4: Domenico Di Giorgio AIFA Italy / SPOC model cooperation against co...International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 4: Collaboration within and between countries
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanSession 3: Salmah Bahri - Ministry of Health, Malaysia / Monitoring of Counte...
Session 3: Salmah Bahri - Ministry of Health, Malaysia / Monitoring of Counte...International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanSession 4: Sheuan Lee, International Council of Nurses (ICN) / Practices and ...
Session 4: Sheuan Lee, International Council of Nurses (ICN) / Practices and ...International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines.
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanSession 3: Ivan Ho Pfizer / Counterfeit Medicines Threat to Patient Health an...
Session 3: Ivan Ho Pfizer / Counterfeit Medicines Threat to Patient Health an...International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Session 3: Fu-Wen Chang, nternational Federation of Pharmaceutical Wholesaler...
Session 3: Fu-Wen Chang, nternational Federation of Pharmaceutical Wholesaler...International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 3: Practices and Technologies for Prevention, Detection, Control and Monitoring of Fake Medicines
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanAfternoon Session Opening: Jim Dahl, Partnership for Safe Medicines
Afternoon Session Opening: Jim Dahl, Partnership for Safe MedicinesInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanSession 2: Mike Rose, Johnson & Johnson / Serialization and Traceability GS1 ...
Session 2: Mike Rose, Johnson & Johnson / Serialization and Traceability GS1 ...International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanSession 2: Scott Kammer, Rx360
Session 2: Scott Kammer, Rx360 International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
Session 2: Supply Chain Integrity
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanOpening Session - Cyntia Genole, IFPMA
Opening Session - Cyntia Genole, IFPMAInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, TaiwanSession 1 - Mark Paxton, US FDA / APEC Roadmap to Promote Global Medical Prod...
Session 1 - Mark Paxton, US FDA / APEC Roadmap to Promote Global Medical Prod...International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
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, TaiwanBringing Psoriasis into the Light, Kim kjoeller, Leo Pharma
Bringing Psoriasis into the Light, Kim kjoeller, Leo PharmaInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
The document discusses psoriasis, a chronic skin condition affecting over 125 million people worldwide. Psoriasis causes thickened, red, scaly skin patches that often itch and bleed. It can also cause joint pain and increase risks for other health issues. The document outlines pharmaceutical company efforts to develop new drug treatments for psoriasis, including topical treatments, biologics, and oral medications currently in clinical trials. It emphasizes the need for comprehensive care that coordinates treatment from specialists and considers patients' needs to best manage psoriasis as a chronic condition.IFPA Psoriasis Presentation
IFPA Psoriasis PresentationInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA Geneva Pharma Forum on 9 May 2014
Bringing Psoriasis into the Light
International Federation of Psoriasis Associations
Barbra BohannanInternational Psoriasis Council, Steve O'Dell
International Psoriasis Council, Steve O'DellInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
The document provides an overview of the International Psoriasis Council (IPC) and their partnership with ILDS and IFPA to execute the Global Psoriasis Atlas project. The IPC is a nonprofit organization comprised of the world's leading experts in psoriasis. They aim to advance knowledge of psoriasis and enhance patient care through research, education, and clinical practice guidelines. The document notes that worldwide prevalence and incidence of psoriasis is poorly understood currently. The Global Psoriasis Atlas project aims to address this through collecting epidemiological data on psoriasis prevalence, burden, and natural history across countries to inform policy and improve care.Manaement of Psoriasis in Low Income Countries
Manaement of Psoriasis in Low Income CountriesInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
IFPMA Geneva Pharma Forum on 9 May 2014
Bringing Psoriasis into the Light
Presentation of Professor Mahira Hamdy El Sayed
Dermatology and Venereology, Ain Shams UniversityIFPMA: From Manufacturing to the Vaccinee – the Complex Journey of a Vaccine
IFPMA: From Manufacturing to the Vaccinee – the Complex Journey of a Vaccine International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
David K. Robinson, Ph. D. Vice President, Biologics Head and Executive Director, Biologics and Vaccines CMC Regulatory Merck & Co, Inc.
Presenting on behalf of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) WCBP CASS, Washington DC, USA January 2014The Complex Journey of a Vaccine
The Complex Journey of a VaccineInternational Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
This document is comprised of copyright notices from the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) spanning the years 2014 through 2018, suggesting it contains content owned by IFPMA over those years. No other substantive information is provided in the document.More from International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) (20)
Session 4: Bejon Misra Partnership for Safe Medicines (PSM) INDIA /
Session 4: Bejon Misra Partnership for Safe Medicines (PSM) INDIA /
Session 4 Sabine Walser Council of Europe / Legal framework necessary for eff...
Session 4 Sabine Walser Council of Europe / Legal framework necessary for eff...
Session 4: Domenico Di Giorgio AIFA Italy / SPOC model cooperation against co...
Session 4: Domenico Di Giorgio AIFA Italy / SPOC model cooperation against co...
Session 3: Salmah Bahri - Ministry of Health, Malaysia / Monitoring of Counte...
Session 3: Salmah Bahri - Ministry of Health, Malaysia / Monitoring of Counte...
Session 4: Sheuan Lee, International Council of Nurses (ICN) / Practices and ...
Session 4: Sheuan Lee, International Council of Nurses (ICN) / Practices and ...
Session 3: Ivan Ho Pfizer / Counterfeit Medicines Threat to Patient Health an...
Session 3: Ivan Ho Pfizer / Counterfeit Medicines Threat to Patient Health an...
Session 3: Fu-Wen Chang, nternational Federation of Pharmaceutical Wholesaler...
Session 3: Fu-Wen Chang, nternational Federation of Pharmaceutical Wholesaler...
Afternoon Session Opening: Jim Dahl, Partnership for Safe Medicines
Afternoon Session Opening: Jim Dahl, Partnership for Safe Medicines
Session 2: Mike Rose, Johnson & Johnson / Serialization and Traceability GS1 ...
Session 2: Mike Rose, Johnson & Johnson / Serialization and Traceability GS1 ...
Session 1 - Mark Paxton, US FDA / APEC Roadmap to Promote Global Medical Prod...
Session 1 - Mark Paxton, US FDA / APEC Roadmap to Promote Global Medical Prod...
Bringing Psoriasis into the Light, Kim kjoeller, Leo Pharma
Bringing Psoriasis into the Light, Kim kjoeller, Leo Pharma
IFPMA: From Manufacturing to the Vaccinee – the Complex Journey of a Vaccine
IFPMA: From Manufacturing to the Vaccinee – the Complex Journey of a Vaccine
Recently uploaded
Travel Clinic Cardiff: Health Advice for International Travelers
Travel Clinic Cardiff offers comprehensive travel health services, including vaccinations, travel advice, and preventive care for international travelers. Our expert team ensures you are well-prepared and protected for your journey, providing personalized consultations tailored to your destination. Conveniently located in Cardiff, we help you travel with confidence and peace of mind. Visit us: www.nxhealthcare.co.uk
10 Benefits an EPCR Software should Bring to EMS Organizations
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
NARCOTICS- POLICY AND PROCEDURES FOR ITS USE
This document outlines policies and procedures for handling narcotic and controlled drugs in NABH accredited hospitals.
DECLARATION OF HELSINKI - History and principles
This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa CentralClinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Cell Therapy Expansion and Challenges in Autoimmune Disease
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
Efficacy of Avartana Sneha in Ayurveda
Avartana Sneha is a unique method of Preparation of Sneha Kalpana in Ayurveda, mainly it is indicated for the Vataja rogas.
Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...
Fallopian tube blockage may cause female infertility. For treatment, herbal medicine Fuyan Pill can be a solution.
Adhd Medication Shortage Uk - trinexpharmacy.com
The UK is currently facing a Adhd Medication Shortage Uk, which has left many patients and their families grappling with uncertainty and frustration. ADHD, or Attention Deficit Hyperactivity Disorder, is a chronic condition that requires consistent medication to manage effectively. This shortage has highlighted the critical role these medications play in the daily lives of those affected by ADHD. Contact : +1 (747) 209 – 3649 E-mail : sales@trinexpharmacy.com
vonoprazan A novel drug for GERD presentation
Vonoprazan, a new potassium acid channel blocker used in the conditions of GERD and gastric ulcer, duodenal ulcer ....
Medical Quiz ( Online Quiz for API Meet 2024 ).pdf
This quiz was conducted as a promotional event for the 2024 Annual Meet of Kerala Chapter of API.
More than 20 participants took part everyday !
Acute Gout Care & Urate Lowering Therapy .pdf
In this document , the management of acute gout attacks and a description of urate lowering therapy is mentioned.
pathology MCQS introduction to pathology general pathology
pathology MCQS introduction to pathology general pathology
June 2024 Oncology Cartoons By Dr Kanhu Charan Patro
une 2024 Oncology Cartoons By Dr Kanhu Charan Patro
Osteoporosis - Definition , Evaluation and Management .pdf
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Top Travel Vaccinations in Manchester
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
Recently uploaded (20)
Travel Clinic Cardiff: Health Advice for International Travelers
Travel Clinic Cardiff: Health Advice for International Travelers
10 Benefits an EPCR Software should Bring to EMS Organizations
10 Benefits an EPCR Software should Bring to EMS Organizations
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Clinic ^%[+27633867063*Abortion Pills For Sale In Tembisa Central
Cell Therapy Expansion and Challenges in Autoimmune Disease
Cell Therapy Expansion and Challenges in Autoimmune Disease
Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...
Demystifying Fallopian Tube Blockage- Grading the Differences and Implication...
Medical Quiz ( Online Quiz for API Meet 2024 ).pdf
Medical Quiz ( Online Quiz for API Meet 2024 ).pdf
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
Vestibulocochlear Nerve by Dr. Rabia Inam Gandapore.pptx
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
CHEMOTHERAPY_RDP_CHAPTER 6_Anti Malarial Drugs.pdf
pathology MCQS introduction to pathology general pathology
pathology MCQS introduction to pathology general pathology
June 2024 Oncology Cartoons By Dr Kanhu Charan Patro
June 2024 Oncology Cartoons By Dr Kanhu Charan Patro
Osteoporosis - Definition , Evaluation and Management .pdf
Osteoporosis - Definition , Evaluation and Management .pdf