IFPMA presentation, UNODC, Technical Conference on the Trafficking in Fraudulent Medicines, William S. Reid, Senior Director, Global Anti-Counterfeiting Operations
Eli Lilly and Company (Vienna, 15 Feb 2013)
Dr Gauden Galea, Director of Noncommunicable Diseases and Life-course at WHO Europe, addressed the European Week Against Cancer conference in Dublin, Ireland on May 29th, 2013.
“WHO Medicines Safety Programme: Pharmacovigilance and risk minimization programs for biological products”
Illustrates the WHO work program on pharmacovigilance, with a focus on both small molecule chemically-synthesized medicines and biotherapeutics
Dr Gauden Galea, Director of Noncommunicable Diseases and Life-course at WHO Europe, addressed the European Week Against Cancer conference in Dublin, Ireland on May 29th, 2013.
“WHO Medicines Safety Programme: Pharmacovigilance and risk minimization programs for biological products”
Illustrates the WHO work program on pharmacovigilance, with a focus on both small molecule chemically-synthesized medicines and biotherapeutics
Illustrates key pharmacovigilance considerations for biotherapeutic medicines “Pharmacovigilance Aspects of Biotherapeutic medicines:Nowadays and Perspectives”
“Biotherapy Drug Circulation Regulation in the Republic of Belarus. Current Status and Long-Term Prospects”
Illustrates the current norms in place in Belorussia for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars
“Challenges of biosimilar product development and experience gained”
Shows the development process for biosimilars, focusing specifically on the company’s experience
Presentation created for Jordi Serrano Pons who was invited to present at the ITU Experts Group Meeting held within the framework of the ITU European Regional Initiative on ICT Applications, including e-Health.
Topic of the meeting:
M-HEALTH: TOWARDS BETTER CARE, CURE AND PREVENTION IN EUROPE
THE CHANGING FACE OF PHARMA! A MULTISTAKEHOLDER APPROACH TO SUSTAINABLE LEADE...Matt Smith
In the presentation, Saurabh Uboweja, CEO Brands Of Desire speaks about the challenges faced by the pharma industries, scope of communication in pharma, how the relationship of pharma industry is changing with the patients & what theses companies should do to communicate better. Go through the presentation & know about the changing faces of Pharma. Brands of Desire is Asia's leading brand consultancy with its offices in New Delhi, Mumbai, Munich and Sharjah. To know in detail about the company, you can visit http://www.brandsofdesire.com
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, Taiwan
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Integration of health records in the prescription drug monitoring programAlayziaHarris
Through the Future of Florida Summit hosted by UF's Bob Graham Center, my team and I were tasked to find solutions to a current health issue. We wanted to focus on the opioid epidemic and tackle this crisis by implementing improvements towards regulation.
I suspect the news my smartphone will soon turn into my doctor is exaggerated. While a consultation with my phone will always be easier to arrange than an appointment with my GP, I know for a fact that even the techiest among us still want to see a living, breathing, qualified person when they’re under the weather.
I say this with confidence as this is one of the key findings from the first ever mHealth report by Ruder Finn. The report, based on a survey of more than 1,000 smartphone and tablet users, shows that while there’s an appetite for healthcare applications, and consumers generally love a good app, developers of health applications have not convinced the public of this kind of app’s value to them. The survey’s results show that apps for social media, games and news are the most popular with users of smartphones and tablets; healthy living apps languish in last place in terms of popularity.
The survey, conducted on our behalf by pollster YouGov, reveals some interesting links between type of device and the likelihood of the user to use health & lifestyle apps. The research suggests apps that help take away some of the pain associated with healthcare – booking appointments and getting hold of test results for example – are more popular than those to actually manage health. Our results suggested a great deal of caution around apps to help patients manage long term health conditions – significantly even among those suffering from chronic disease/ health problems. These findings may come as a disappointment to the World Health Organization, which along with The International Telecommunication Union (ITU), is launching an mHealth initiative to help combat noncommunicable diseases, based on the fact that mHealth is cost effective, scalable and sustainable.
In our survey, there is a difference between the generations and the impact that might have on app usage. While 75% of respondents between 25-34 owned a smartphone fewer than 30% in the 55+ category did. Although everyone accesses healthcare it’s usually the oldest among us who use it most. It will be interesting to see how usage patterns change as the gamers and Tweeters of today get older.
This presentation also contains slides from Prof. Christopher James
Professor of Healthcare Technology (University of Warwick) and
Director, Institute of Digital Healthcare; Dr Tom Barber
Associate Professor and Honorary Consultant Endocrinologist,
University of Warwick and UHCW NHS Trust and Owen Booth
Head of Content, Diabetes UK.
The event can be seen at the hashtag #rfmhealth too.
Estratégias sobre Segurança do Paciente: Cuidados de Saúde para todos, sempre...Proqualis
Aula de Itziar Larizgoitia Jauregui, Coordenadora de Pesquisa e Gestão do Conhecimento do Programa de Segurança do Paciente da Organização Mundial de Saúde (OMS), durante o II Seminário Internacional sobre Qualidade em Saúde e Segurança do Paciente - evento do Qualisus - nos dias 13 e 14 de Agosto de 2013, no Ministério da Saúde, em Brasília.
Geneva Pharma Forum on Pharmacovigilance: Partnering for
Patient Safety (Geneva, 20 November 2012), Jeremiah Mwangi, Director, Policy and External Affairs, IAPO
Ethical Implications of Orphan Drug Research IncentivesKuldeep Badoniya
1. This presentation will go over the implications of research incentives limited to orphan drugs.
2. It will demonstrate the case and summarize the key points from a high level. Furthermore, this will provide a basis on how to address the the dilemmas.
NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey
Prepared By - Jing Mi, Ali Raza and Kuldeep Badoniya
Illustrates key pharmacovigilance considerations for biotherapeutic medicines “Pharmacovigilance Aspects of Biotherapeutic medicines:Nowadays and Perspectives”
“Biotherapy Drug Circulation Regulation in the Republic of Belarus. Current Status and Long-Term Prospects”
Illustrates the current norms in place in Belorussia for the marketing authorization of pharmaceutical products and the dossier requirements for biotherapeutics & biosimilars
“Challenges of biosimilar product development and experience gained”
Shows the development process for biosimilars, focusing specifically on the company’s experience
Presentation created for Jordi Serrano Pons who was invited to present at the ITU Experts Group Meeting held within the framework of the ITU European Regional Initiative on ICT Applications, including e-Health.
Topic of the meeting:
M-HEALTH: TOWARDS BETTER CARE, CURE AND PREVENTION IN EUROPE
THE CHANGING FACE OF PHARMA! A MULTISTAKEHOLDER APPROACH TO SUSTAINABLE LEADE...Matt Smith
In the presentation, Saurabh Uboweja, CEO Brands Of Desire speaks about the challenges faced by the pharma industries, scope of communication in pharma, how the relationship of pharma industry is changing with the patients & what theses companies should do to communicate better. Go through the presentation & know about the changing faces of Pharma. Brands of Desire is Asia's leading brand consultancy with its offices in New Delhi, Mumbai, Munich and Sharjah. To know in detail about the company, you can visit http://www.brandsofdesire.com
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, Taiwan
Patient-centered pharmacovigilance represents a pivotal shift in the landscape of healthcare, emphasizing the active involvement of patients in the monitoring and reporting of adverse drug reactions. Unlike traditional pharmacovigilance, which primarily relies on healthcare professionals to identify and document adverse events, this approach recognizes patients as critical stakeholders in ensuring medication safety. By empowering patients to share their experiences, concerns, and observations regarding medication effects, whether positive or negative, healthcare systems can gain a comprehensive understanding of drug safety and efficacy in real-world settings. Patient-centered pharmacovigilance fosters a collaborative partnership between patients, healthcare providers, and regulatory agencies, promoting transparency, accountability, and ultimately, better patient outcomes. Through increased patient engagement and the utilization of patient-reported data, this approach enables healthcare systems to identify potential safety issues earlier, tailor treatment strategies to individual needs, and enhance overall drug safety surveillance efforts.
Integration of health records in the prescription drug monitoring programAlayziaHarris
Through the Future of Florida Summit hosted by UF's Bob Graham Center, my team and I were tasked to find solutions to a current health issue. We wanted to focus on the opioid epidemic and tackle this crisis by implementing improvements towards regulation.
I suspect the news my smartphone will soon turn into my doctor is exaggerated. While a consultation with my phone will always be easier to arrange than an appointment with my GP, I know for a fact that even the techiest among us still want to see a living, breathing, qualified person when they’re under the weather.
I say this with confidence as this is one of the key findings from the first ever mHealth report by Ruder Finn. The report, based on a survey of more than 1,000 smartphone and tablet users, shows that while there’s an appetite for healthcare applications, and consumers generally love a good app, developers of health applications have not convinced the public of this kind of app’s value to them. The survey’s results show that apps for social media, games and news are the most popular with users of smartphones and tablets; healthy living apps languish in last place in terms of popularity.
The survey, conducted on our behalf by pollster YouGov, reveals some interesting links between type of device and the likelihood of the user to use health & lifestyle apps. The research suggests apps that help take away some of the pain associated with healthcare – booking appointments and getting hold of test results for example – are more popular than those to actually manage health. Our results suggested a great deal of caution around apps to help patients manage long term health conditions – significantly even among those suffering from chronic disease/ health problems. These findings may come as a disappointment to the World Health Organization, which along with The International Telecommunication Union (ITU), is launching an mHealth initiative to help combat noncommunicable diseases, based on the fact that mHealth is cost effective, scalable and sustainable.
In our survey, there is a difference between the generations and the impact that might have on app usage. While 75% of respondents between 25-34 owned a smartphone fewer than 30% in the 55+ category did. Although everyone accesses healthcare it’s usually the oldest among us who use it most. It will be interesting to see how usage patterns change as the gamers and Tweeters of today get older.
This presentation also contains slides from Prof. Christopher James
Professor of Healthcare Technology (University of Warwick) and
Director, Institute of Digital Healthcare; Dr Tom Barber
Associate Professor and Honorary Consultant Endocrinologist,
University of Warwick and UHCW NHS Trust and Owen Booth
Head of Content, Diabetes UK.
The event can be seen at the hashtag #rfmhealth too.
Estratégias sobre Segurança do Paciente: Cuidados de Saúde para todos, sempre...Proqualis
Aula de Itziar Larizgoitia Jauregui, Coordenadora de Pesquisa e Gestão do Conhecimento do Programa de Segurança do Paciente da Organização Mundial de Saúde (OMS), durante o II Seminário Internacional sobre Qualidade em Saúde e Segurança do Paciente - evento do Qualisus - nos dias 13 e 14 de Agosto de 2013, no Ministério da Saúde, em Brasília.
Geneva Pharma Forum on Pharmacovigilance: Partnering for
Patient Safety (Geneva, 20 November 2012), Jeremiah Mwangi, Director, Policy and External Affairs, IAPO
Ethical Implications of Orphan Drug Research IncentivesKuldeep Badoniya
1. This presentation will go over the implications of research incentives limited to orphan drugs.
2. It will demonstrate the case and summarize the key points from a high level. Furthermore, this will provide a basis on how to address the the dilemmas.
NOTE - This presentation was made as part of an assignment for a Course PME 542 (Regulation and Compliance in the Pharmaceutical Industry) at Stevens Institute of Technology, Hoboken, New Jersey
Prepared By - Jing Mi, Ali Raza and Kuldeep Badoniya
Global Dementia Legacy Event: Raj Long, Senior Regulatory OfficerDepartment of Health
Session Two: Barriers to investment in research to find a disease modifying therapy or cure for dementia.
Raj Long, Senior Regulatory Officer – Integrated Development, Global Health at the Bill & Melinda Gates Foundation & World Dementia Council Member
The Role of Pharmacovigilance in Ensuring Drug Safety and EfficacyClinosolIndia
Pharmacovigilance plays a vital role in ensuring drug safety and efficacy throughout the entire lifecycle of a pharmaceutical product. Here are the key aspects of pharmacovigilance in safeguarding public health:
Early Detection of Adverse Drug Reactions (ADRs): Pharmacovigilance systems collect and analyze data on ADRs reported by healthcare professionals and patients. This enables the early detection of potential safety concerns associated with drugs, including known and previously unrecognized adverse effects.
Signal Detection and Evaluation: Pharmacovigilance activities involve the systematic identification and evaluation of safety signals, which are indications of potential risks associated with a drug. Signals are assessed by analyzing data from various sources, such as spontaneous reports, clinical trials, literature, and real-world evidence, to determine their clinical significance and inform regulatory action if necessary.
Risk Assessment and Benefit-Risk Evaluation: Pharmacovigilance assesses the balance between the benefits and risks of drugs. The collected data are evaluated to determine whether the benefits of a drug outweigh its risks or if any additional safety measures are required. This information guides regulatory decisions, such as labeling changes, restrictions, or even withdrawal of the drug from the market.
Post-Marketing Surveillance: Pharmacovigilance is crucial in monitoring the safety of drugs after they have been approved and marketed. It involves ongoing surveillance and analysis of real-world data, including ADR reports, electronic health records, and other sources, to identify new or rare adverse effects that may emerge in larger patient populations or specific subgroups.
Similar to Ifpma william reid_unodc_conference on fraudulent medicines_15_feb2013 (20)
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, Taiwan
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, Taiwan
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, Taiwan
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, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
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, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
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, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
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, Taiwan
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
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
IFPMA Geneva Pharma Forum on 9 May 2014
Bringing Psoriasis into the Light
Presentation of Kim kjoeller, Senior Vice President
Global Development, Leo Pharma
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 University
David K. Robinson, Ph. D.Vice President, BiologicsHead and Executive Director, Biologics and Vaccines CMC RegulatoryMerck & Co, Inc.
Presenting on behalf of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)WCBP CASS, Washington DC, USAJanuary 2014
5. Our Recent Initiatives
UCL policy Position on FIP-IFPMA Workshop:
report: Internet Document: The threat of
Falsified Sales and The threat of false friends
medicines Access to false friends Fake medicine -
and global Safe Imminent Risks
public’s Medicines to Global Health
health