Just to remind you that registrations for our 18th Pharmacovigilance 2019 event, which is taking place at The Pestana Chelsea Bridge Hotel in London, UK on 27-28th Feb are closing soon.For more details email to dinesh@virtueinsightsummits.com
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “5th Pharmacovigilance Congregation 2013” The conference will be held on 20th November 2013, Kohinoor Continental Hotel, Mumbai, India.
BIOSIMILARS - Regulation and Market Trends Joseph Pategou
Nowadays patients and physicians can have access to three types of drugs: a originators, a generic or a biosimilar.
Those drugs have different regulatory systems that apply in Europe; moreover the biosimilars regulation is evolving and may change. Regulation is an important factor that can give more confidence to patients and healthcare professionals. As a consequence, biosimilaires will grow.
Oncology biosimilars Market Report in PPT: Top Companies, Trends and Future D...IMARC Group
According to the latest report by IMARC Group,the global oncology biosimilars market exhibited strong growth during 2015-2020.
Oncology biosimilars are cost-effective counterparts of the already licensed reference biologics.
Healthcare and Business Advantage: the Case of SanofiJoseph Pategou
Leading Competitive Intelligence: Turn Strategic & Technologic watches into business advantage
The What : Using CI investments and initiatives to in order to collect, process and store information to be made available to all people at all levels of the firm to help shape its future.
The How : successful competitive intelligence execution depends as much on how firms manage competitive intelligence than solely implementing CI processes, if not more.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
The material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and effectiveness of pharmaceutical products. In the following modules we will introduce and describe the highly specialized and often disconnected components of pharmaceutical research, drug development/manufacturing, marketing, regulatory policies and practices, and use case studies to qualify the relative effectiveness of safeguards to prevent harm. Additionally, how have pressures to reduce health care costs or increase safety actually affected both aspects of public concern within a global context because transnational interests influence national circumstances.
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “5th Pharmacovigilance Congregation 2013” The conference will be held on 20th November 2013, Kohinoor Continental Hotel, Mumbai, India.
BIOSIMILARS - Regulation and Market Trends Joseph Pategou
Nowadays patients and physicians can have access to three types of drugs: a originators, a generic or a biosimilar.
Those drugs have different regulatory systems that apply in Europe; moreover the biosimilars regulation is evolving and may change. Regulation is an important factor that can give more confidence to patients and healthcare professionals. As a consequence, biosimilaires will grow.
Oncology biosimilars Market Report in PPT: Top Companies, Trends and Future D...IMARC Group
According to the latest report by IMARC Group,the global oncology biosimilars market exhibited strong growth during 2015-2020.
Oncology biosimilars are cost-effective counterparts of the already licensed reference biologics.
Healthcare and Business Advantage: the Case of SanofiJoseph Pategou
Leading Competitive Intelligence: Turn Strategic & Technologic watches into business advantage
The What : Using CI investments and initiatives to in order to collect, process and store information to be made available to all people at all levels of the firm to help shape its future.
The How : successful competitive intelligence execution depends as much on how firms manage competitive intelligence than solely implementing CI processes, if not more.
Safety Data Exchange Agreements (Brief)
An integral part of enterprise risk management systems
Strategic management framework
Governance model
Standards, mechanisms, and metrics for management oversight
Roles and responsibilities
Stakeholder collaboration
Procedural documents and SDEA templates
CAPA management processes
Supporting systems
Document repositories
The material included in these modules serves many interests by facilitating understanding of construct, dynamics, and influences affecting regulatory policies and corporate decision-making that ultimately determine access, availability, and effectiveness of pharmaceutical products. In the following modules we will introduce and describe the highly specialized and often disconnected components of pharmaceutical research, drug development/manufacturing, marketing, regulatory policies and practices, and use case studies to qualify the relative effectiveness of safeguards to prevent harm. Additionally, how have pressures to reduce health care costs or increase safety actually affected both aspects of public concern within a global context because transnational interests influence national circumstances.
Originators and Princeps: How to face Biosimilars and Generics Joseph Pategou
Concerning the levers a originators producer can put in place to face the biosimilars competition and maintain his position, benchmarking on biosimilars, generics (13 companies from 2000 to 2015) and the results of our interview allow us to observe 10 levers:
Price Prescription
Patent Market saturation
Legal action New market
Cooperation Environmental strategy
Product Brand strategy
February 18, 2016
The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.
This panel discussion brought together experts from legal practice, industry, and academia to discuss each of these issues and to recommend ways in which the agency and industry can move forward.
For more information, visit the website: http://petrieflom.law.harvard.edu/events/details/viability-of-fda-biosimilar-pathway.
This presentation provides a comprehensive overview of the current pharmaceutical industry. It begins with a look at some of the changes facing the industry and then moves into a discussion on digital technology and its impact on pharmaceutical companies. From there, the deck explores two digital trends, mobile and eDetailing. The presentation wraps up with some examples of pharmaceutical companies their digital presence.
European pharmacovigilance and_clinical_trials_2016Fazmina Fajju
The European Pharmacovigilance & Clinical Trials 2016 offers a one of a kind discussion platform for pharmaceutical experts to debate and discuss the challenges they are facing in Pharmacovigilance and Clinical Trials.
Do not miss out on the chance to acquire first-hand knowledge and experiences from pharmaceutical giants such as AstraZeneca, Merck Sereno, Boehringer Ingelheim, Pfizer, Novo Nordisk, Johnson & Johnson, Novartis and many more on the latest technological advances in data capture and effective feasibility models. We will be addressing topics such as Major challenges faced by EU legislation and Emerging Economies and PV Harmonization, Adverse event reporting and PV & clinical trials, Clinical Trials Signal Detection and many others. Join us and be future ready!
Take advantage to meet the leading experts within the field and discuss the latest challenges all your competitors are facing.
We are looking forward to welcoming you on board in 2016!
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
This presentation covers the Introduction to Healthcare & different Products, Role of Pharmaceutical in Healthcare, Drug Details, What a drug is made of ?, Classification of drugs, Product Life Cycle of a Drug, Drug Development Phases, Regulatory Framework & various Regulatory Bodies
Global regenerative medicines market (technology, application and geography) ...Allied Market Research
Regenerative medicines have the unique ability to repair, replace and regenerate tissues and organs, affected due to some injury, disease or due to natural aging process.
Orphan drugs market Report with Leading Competitor Analysis, Strategies and F...IMARC Group
The global orphan drugs market exhibited moderate growth during 2014-2019. Looking forward, IMARC Group expects the global orphan drugs market to exhibit moderate growth during the next five years.
To learn more about this market, visit us at: https://www.imarcgroup.com/orphan-drugs-market
We are regularly tracking the direct effect of COVID-19 on the market, along with the indirect influence of associated industries. These observations will be integrated into the report.
The report provides an analysis of the key trends in each sub-segment of the global orphan drugs market report, along with forecasts for growth at the global, regional and country level from 2020-2025. The competitive landscape of the market has also been analyzed in the report with the detailed profiles of the key players.
For more information, request for a free sample report here: https://www.imarcgroup.com/orphan-drugs-market/requestsample
Contact Us:
IMARC Group
30 N Gould St, Ste R
Sheridan, WY (Wyoming) 82801 USA
Email: Sales@imarcgroup.com
Tel No:(D) +91 120 433 0800
Americas:- +1 631 791 1145 | Africa and Europe :- +44-702-409-7331 | Asia: +91-120-433-0800, +91-120-433-0800
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Global orphan drug market future outlook 2020Rajesh Sarma
"Global Orphan Drug Market Future Outlook 2020" report highlights:
Global Orphan Drug Market Overview
Global Orphan Drug Market Segment Analysis
FDA & EMA Regulation for Clinical Trials Orphan Designated Drugs
Orphan Drug Designation Criteria & Reimbursement Policy by Region
Comprehensive Insight on Global Orphan Drugs Clinical Pipeline & Patent Analysis by Company, Country, Indication & Phase
Global Orphan Drugs Clinical Pipeline: 697 Drugs
Majority Orphan Drugs in Phase-II Trials: 249 Drugs
Marketed Orphan Drugs: 274 Drugs
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
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
According to the latest report by IMARC Group,the global gene expression analysis marketexhibited strong growth during 2015-2020.
Gene expression analysis is extensively used across clinical, research and pharmaceutical settings to study individual genes, gene pathways or greater gene activity profiles.
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will Be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India. Please find the detailed agenda for the same with this email.
FMD:- + 91 9171350244 or deepak@virtueinsight.co.in, deepakrajvirtueinsight@gmail.com
Greeting From Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India.
KEY SPEAKERS:-
• V. Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare Govt. of India
• Arun Bhatt, President, ClinInvent Research
• Deepa Arora, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin
• Bhaswat Chakraborty, Senior Vice President, Cadila
• Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb
• Nipom Deka, Regional Pharmacovigilance Manager, Asia, Africa & Middle East, Abbott
• Shashidhar Swamy, Head Pharmacovigilance, Wockhardt
• Mohammad Salim, Country Safety Lead, Pfizer
• Manish Verma, Director Medical Affairs, Sanofi
• Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi
• Chirag Trivedi, Director & Head of Clinical Study Unit, Sanofi
• Priya Chatterjee, Director - Regulatory Affairs, Merck Serono
• Milind Antani, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associate
• Anand Harugeri, Patient Safety and Regulatory Affairs Manager, Astrazeneca
• Deepti Sanghavi, Assistant Manager - Medical Writing, Tata Consultancy Services
• Sandeep Sewlikar, Manager – Clinical Affairs, Johnson and Johnson
• Girish Parhate, Head Regulatory Affairs, Bayer Pharmaceuticals
• Rajashri Survase Ojha, Founder and MD, Raaj GPRAC
• Vandana Jolad, Director, VIaTal Pharma
Plus Many More...
CONFERENCE BOOKING DETAILS:-
• Early Bird Discounted Price - Conference Delegate Pass (INR 6,000 + Tax (14%) per delegate) - Book and Pay before 20th July 2015 avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Standard Price after Early Bird Discounted Time – 1 or 2 Delegates (INR 7,000 + Tax (14%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14%) per delegate)
• Group Discounts – 5 or more Delegates - (INR 5,000 + Tax (14%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: +91 44 65515695, +91 9940043915 or swetha@virtueinsight.co.in
In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.
Thank you for your time and consideration. I look forward to hearing from you
Thanks,
Swetha
Originators and Princeps: How to face Biosimilars and Generics Joseph Pategou
Concerning the levers a originators producer can put in place to face the biosimilars competition and maintain his position, benchmarking on biosimilars, generics (13 companies from 2000 to 2015) and the results of our interview allow us to observe 10 levers:
Price Prescription
Patent Market saturation
Legal action New market
Cooperation Environmental strategy
Product Brand strategy
February 18, 2016
The 2010 passage of the Biologics Price Competition and Innovation Act was intended to create a pathway for the approval of biosimilar drugs, to bring to market less expensive versions of innovators’ biologic therapeutics in the same way the Hatch-Waxman Act has worked so well for FDA approval of generic small-molecule drugs. But the Act has been mired in a host of statutory, regulatory, and scientific complication and delays, and five years later, the FDA has approved just one biosimilar product.
This panel discussion brought together experts from legal practice, industry, and academia to discuss each of these issues and to recommend ways in which the agency and industry can move forward.
For more information, visit the website: http://petrieflom.law.harvard.edu/events/details/viability-of-fda-biosimilar-pathway.
This presentation provides a comprehensive overview of the current pharmaceutical industry. It begins with a look at some of the changes facing the industry and then moves into a discussion on digital technology and its impact on pharmaceutical companies. From there, the deck explores two digital trends, mobile and eDetailing. The presentation wraps up with some examples of pharmaceutical companies their digital presence.
European pharmacovigilance and_clinical_trials_2016Fazmina Fajju
The European Pharmacovigilance & Clinical Trials 2016 offers a one of a kind discussion platform for pharmaceutical experts to debate and discuss the challenges they are facing in Pharmacovigilance and Clinical Trials.
Do not miss out on the chance to acquire first-hand knowledge and experiences from pharmaceutical giants such as AstraZeneca, Merck Sereno, Boehringer Ingelheim, Pfizer, Novo Nordisk, Johnson & Johnson, Novartis and many more on the latest technological advances in data capture and effective feasibility models. We will be addressing topics such as Major challenges faced by EU legislation and Emerging Economies and PV Harmonization, Adverse event reporting and PV & clinical trials, Clinical Trials Signal Detection and many others. Join us and be future ready!
Take advantage to meet the leading experts within the field and discuss the latest challenges all your competitors are facing.
We are looking forward to welcoming you on board in 2016!
The impact on information flow, safety and labelling documents, document granularity, naming of documents and metadata, the preparation and submissions of XEVMPD dossiers
This presentation covers the Introduction to Healthcare & different Products, Role of Pharmaceutical in Healthcare, Drug Details, What a drug is made of ?, Classification of drugs, Product Life Cycle of a Drug, Drug Development Phases, Regulatory Framework & various Regulatory Bodies
Global regenerative medicines market (technology, application and geography) ...Allied Market Research
Regenerative medicines have the unique ability to repair, replace and regenerate tissues and organs, affected due to some injury, disease or due to natural aging process.
Orphan drugs market Report with Leading Competitor Analysis, Strategies and F...IMARC Group
The global orphan drugs market exhibited moderate growth during 2014-2019. Looking forward, IMARC Group expects the global orphan drugs market to exhibit moderate growth during the next five years.
To learn more about this market, visit us at: https://www.imarcgroup.com/orphan-drugs-market
We are regularly tracking the direct effect of COVID-19 on the market, along with the indirect influence of associated industries. These observations will be integrated into the report.
The report provides an analysis of the key trends in each sub-segment of the global orphan drugs market report, along with forecasts for growth at the global, regional and country level from 2020-2025. The competitive landscape of the market has also been analyzed in the report with the detailed profiles of the key players.
For more information, request for a free sample report here: https://www.imarcgroup.com/orphan-drugs-market/requestsample
Contact Us:
IMARC Group
30 N Gould St, Ste R
Sheridan, WY (Wyoming) 82801 USA
Email: Sales@imarcgroup.com
Tel No:(D) +91 120 433 0800
Americas:- +1 631 791 1145 | Africa and Europe :- +44-702-409-7331 | Asia: +91-120-433-0800, +91-120-433-0800
IFPMA-TFDA Workshop on Couterfeit Medicines
‘Integrated Approach Against Fake Medicines’
On 6th February 2015
At Taipei International Convention Center
Taipei, Taiwan
Global orphan drug market future outlook 2020Rajesh Sarma
"Global Orphan Drug Market Future Outlook 2020" report highlights:
Global Orphan Drug Market Overview
Global Orphan Drug Market Segment Analysis
FDA & EMA Regulation for Clinical Trials Orphan Designated Drugs
Orphan Drug Designation Criteria & Reimbursement Policy by Region
Comprehensive Insight on Global Orphan Drugs Clinical Pipeline & Patent Analysis by Company, Country, Indication & Phase
Global Orphan Drugs Clinical Pipeline: 697 Drugs
Majority Orphan Drugs in Phase-II Trials: 249 Drugs
Marketed Orphan Drugs: 274 Drugs
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
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
According to the latest report by IMARC Group,the global gene expression analysis marketexhibited strong growth during 2015-2020.
Gene expression analysis is extensively used across clinical, research and pharmaceutical settings to study individual genes, gene pathways or greater gene activity profiles.
Greetings from Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will Be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India. Please find the detailed agenda for the same with this email.
FMD:- + 91 9171350244 or deepak@virtueinsight.co.in, deepakrajvirtueinsight@gmail.com
Greeting From Virtue Insight,
I am happy to invite you and your colleagues to be a sponsor/ delegate for our upcoming “9th Pharmacovigilance 2015” The conference will be held on 2nd September 2015, Kohinoor Continental Hotel, Mumbai, India.
KEY SPEAKERS:-
• V. Kalaiselvan, Principal Scientific Officer, Indian Pharmacopoeia Commission Ministry of Health and Family Welfare Govt. of India
• Arun Bhatt, President, ClinInvent Research
• Deepa Arora, Vice President - Pharmacovigilance & Global Head - Drug Safety & Risk Management, Lupin
• Bhaswat Chakraborty, Senior Vice President, Cadila
• Babita Kirodian, Head of Country Pharmacovigilance, Bristol Myers Squibb
• Nipom Deka, Regional Pharmacovigilance Manager, Asia, Africa & Middle East, Abbott
• Shashidhar Swamy, Head Pharmacovigilance, Wockhardt
• Mohammad Salim, Country Safety Lead, Pfizer
• Manish Verma, Director Medical Affairs, Sanofi
• Karthik Babu, Affiliate Pharmacovigilance Head, Sanofi
• Chirag Trivedi, Director & Head of Clinical Study Unit, Sanofi
• Priya Chatterjee, Director - Regulatory Affairs, Merck Serono
• Milind Antani, Partner In-Charge - Pharma LifeSciences, Nishith Desai Associate
• Anand Harugeri, Patient Safety and Regulatory Affairs Manager, Astrazeneca
• Deepti Sanghavi, Assistant Manager - Medical Writing, Tata Consultancy Services
• Sandeep Sewlikar, Manager – Clinical Affairs, Johnson and Johnson
• Girish Parhate, Head Regulatory Affairs, Bayer Pharmaceuticals
• Rajashri Survase Ojha, Founder and MD, Raaj GPRAC
• Vandana Jolad, Director, VIaTal Pharma
Plus Many More...
CONFERENCE BOOKING DETAILS:-
• Early Bird Discounted Price - Conference Delegate Pass (INR 6,000 + Tax (14%) per delegate) - Book and Pay before 20th July 2015 avail the early bird discounted price. You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Standard Price after Early Bird Discounted Time – 1 or 2 Delegates (INR 7,000 + Tax (14%) per delegate) - You can simply email or call and book your conference delegate seats on TEL: +91 9940043915. Email – swetha@virtueinsight.co.in
• Group Discounts – 3 or 4 Delegates - (INR 6,500 + Tax (14%) per delegate)
• Group Discounts – 5 or more Delegates - (INR 5,000 + Tax (14%) per delegate)
• Conference Sponsor & Exhibition Stall - Should you wish to Sponsor, or purchase a Exhibition Stall (Booth) or a paid Speaker Slot, you can simply email your interest and queries to TEL: +91 44 65515695, +91 9940043915 or swetha@virtueinsight.co.in
In case you or any of your colleagues might be interested in participating in the same, please let me know and I will be happy to call you and help you with the registration.
Thank you for your time and consideration. I look forward to hearing from you
Thanks,
Swetha
7th Pharmacovigilance 2014 “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management" 21st November 2014, Kohinoor Continental Hotel, Mumbai, India Greetings from Virtue Insight, I am happy to invite you and your colleagues to be a sponsor / delegate for our upcoming conference. The “Ensuring safer drugs to market by analyzing latest developments in pharmacovigilance, drug safety and risk management” at 7th Pharmacovigilance 2014 on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.Contact:-Tel: +91 9677590192 Email: dinesh@virtueinsight.co.in
I am writing to make you aware of our upcoming event:- 7th Pharmacovigilance 2014 taking place on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.
The global acquired orphan blood diseases therapeutics market size reached US$ 8.12 Billion in 2022. Looking forward, IMARC Group expects the market to reach US$ 13.34 Billion by 2028, exhibiting a growth rate (CAGR) of 8.30% during 2023-2028.
More Info:- https://www.imarcgroup.com/acquired-orphan-blood-diseases-therapeutics-market
Pneumonia Market 2023: Epidemiology, Industry Trends, Size, Share And Forecas...frankmorgan27
The pneumonia market is witnessing significant growth due to the rising cases of HIV/AIDS and cancer, which compromise immune systems and increase susceptibility to infections.
The global acquired orphan blood diseases therapeutics market size reached US$ 8.8 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 17.2 Billion by 2032, exhibiting a growth rate (CAGR) of 7.5% during 2024-2032.
More Info:- https://www.imarcgroup.com/acquired-orphan-blood-diseases-therapeutics-market
its not my personal work presentation but taken from lecture ppt from university of San Diego, california.
Its about the drug discovery process, its development and its commercialization.
European pharmacovigilance and clinical trials 2016Harris John
European Pharmacovigilance and Clinical Trials 2016 will provide an opportunity to all its attendees to discuss, share and stay updated with present state of affairs in Pharmacovigilance and clinical trials. It will also allow all its participants to discuss the various developments, challenges faced and innovations in the field. The conference will attempt to explore the reforms required to enhance drug safety and public health. The conference will also provides all its participants an opportunity to network with various pharmaceutical industries; clinical research organizations and PV service providers.
Virtual Workshop Innovative Approaches to Drug Safety 2019Arete-Zoe, LLC
The current practice of pharmacovigilance is fraught with challenges and limitations. Still, new technologies, perspectives, and concerns are shaping the way stakeholders will need to conduct this crucial activity in the coming years. You are cordially invited to join our workshop on the future of pharmacovigilance. We offer you an opportunity to participate in a robust, informative, and professional discussion about the future of pharmacovigilance. We seek your perspectives on the issues before us today and how they will influence the drug safety environment in the 2020s.
We understand the challenges and limitations of the current ways to conduct the business of pharmacovigilance and seek your perspective to achieve broader consensus. Topics of interest include the role of stakeholders in shaping the informational needs, system responsiveness, production of real-world evidence, incentives and barriers to investment
into automation and AI tools, the monetary value of safety information, patient privacy issues, and innovative approaches toward generating evidence.
PPT-Metagenomics Market Growth, Demand and Challenges of the Key Industry Pl...IMARC Group
According to the latest report by IMARC Group,the global metagenomics market exhibited strong growth during 2015-2020.Metagenomics refers to the research field that assists researchers in studying the characteristics of genetic substances that are acquired from environmental samples. It involves the usage of multiple molecular tools, such as bioinformatics and sequencing techniques, in order to determine the insights of microbial genomes and analyze the structure of the human microbiome.
Global pharmaceutical companies are modeled with a supply chain, which ensures that the right drug reaches the right people at the right time and in the right condition. The supply chain also ensures 100% product availability at optimum cost by carrying huge inventory, which maintains 100% fill rate. Manufacturers are trying to cut down development time to save costs. For example, a drug manufacturer who can trim development time by 19% can save up to USD 100 million. But if a drug is getting delayed to reach the market, the time delay costs the company around USD 1 million a day. So, pharmaceutical companies today are designing the supply chain to be as responsive as possible to reduce entry time to the market thereby increasing profit margins.
4th annual Pharma Anti-Counterfeiting 2015Dinesh T
4th Annual Pharma Anti-Counterfeiting 2015 taking place on 08th & 09th September 2015, London, UK
Please contact me :-Dinesh:- dinesh@virtueinsight.co.in
8th Pharmacovigilance 2015 taking place on 24th & 25th Feb 2015, Marriott Marble Arch Hotel, London UK.
Please contact me:-Dinesh:- dinesh@virtueinsight.co.in with further details
8th Pharmacovigilance 2015 taking place on 24th & 25th Feb 2015, Marriott Marble Arch Hotel, London UK
Please contact me:-Dinesh:- dinesh@virtueinsight.co.in with further details
8th Pharmacovigilance 2015 taking place on 24th & 25th Feb 2015, Marriott Marble Arch Hotel, London UK
Key speakers from Merck, Pfizer, Lilly, Takeda, Parexel, INSERM, ERA, NDA, Ranbaxy, Bristows,Norwegian Medicines Agency & many more ,
Email your interest and queries to:- dinesh@virtueinsight.co.in
I am writing to make you aware of our upcoming event:- 7th Pharmacovigilance 2014 taking place on 21st November 2014, Kohinoor Continental Hotel, Mumbai, India.
Core Web Vitals SEO Workshop - improve your performance [pdf]Peter Mead
Core Web Vitals to improve your website performance for better SEO results with CWV.
CWV Topics include:
- Understanding the latest Core Web Vitals including the significance of LCP, INP and CLS + their impact on SEO
- Optimisation techniques from our experts on how to improve your CWV on platforms like WordPress and WP Engine
- The impact of user experience and SEO
The digital marketing industry is changing faster than ever and those who don’t adapt with the times are losing market share. Where should marketers be focusing their efforts? What strategies are the experts seeing get the best results? Get up-to-speed with the latest industry insights, trends and predictions for the future in this panel discussion with some leading digital marketing experts.
Most small businesses struggle to see marketing results. In this session, we will eliminate any confusion about what to do next, solving your marketing problems so your business can thrive. You’ll learn how to create a foundational marketing OS (operating system) based on neuroscience and backed by real-world results. You’ll be taught how to develop deep customer connections, and how to have your CRM dynamically segment and sell at any stage in the customer’s journey. By the end of the session, you’ll remove confusion and chaos and replace it with clarity and confidence for long-term marketing success.
Key Takeaways:
• Uncover the power of a foundational marketing system that dynamically communicates with prospects and customers on autopilot.
• Harness neuroscience and Tribal Alignment to transform your communication strategies, turning potential clients into fans and those fans into loyal customers.
• Discover the art of automated segmentation, pinpointing your most lucrative customers and identifying the optimal moments for successful conversions.
• Streamline your business with a content production plan that eliminates guesswork, wasted time, and money.
Everyone knows the power of stories, but when asked to come up with them, we struggle. Either we second guess ourselves as to the story's relevance, or we just come up blank and can't think of any. Unlocking Everyday Narratives: The Power of Storytelling in Marketing will teach you how to recognize stories in the moment and to recall forgotten moments that your audience needs to hear.
Key Takeaways:
Understand Why Personal Stories Connect Better
How To Remember Forgotten Stories
How To Use Customer Experiences As Stories For Your Brand
Videos are more engaging, more memorable, and more popular than any other type of content out there. That’s why it’s estimated that 82% of consumer traffic will come from videos by 2025.
And with videos evolving from landscape to portrait and experts promoting shorter clips, one thing remains constant – our brains LOVE videos.
So is there science behind what makes people absolutely irresistible on camera?
The answer: definitely yes.
In this jam-packed session with Stephanie Garcia, you’ll get your hands on a steal-worthy guide that uncovers the art and science to being irresistible on camera. From body language to words that convert, she’ll show you how to captivate on command so that viewers are excited and ready to take action.
The digital marketing industry is changing faster than ever and those who don’t adapt with the times are losing market share. Where should marketers be focusing their efforts? What strategies are the experts seeing get the best results? Get up-to-speed with the latest industry insights, trends and predictions for the future in this panel discussion with some leading digital marketing experts.
Most small businesses struggle to see marketing results. In this session, we will eliminate any confusion about what to do next, solving your marketing problems so your business can thrive. You’ll learn how to create a foundational marketing OS (operating system) based on neuroscience and backed by real-world results. You’ll be taught how to develop deep customer connections, and how to have your CRM dynamically segment and sell at any stage in the customer’s journey. By the end of the session, you’ll remove confusion and chaos and replace it with clarity and confidence for long-term marketing success.
Key Takeaways:
• Uncover the power of a foundational marketing system that dynamically communicates with prospects and customers on autopilot.
• Harness neuroscience and Tribal Alignment to transform your communication strategies, turning potential clients into fans and those fans into loyal customers.
• Discover the art of automated segmentation, pinpointing your most lucrative customers and identifying the optimal moments for successful conversions.
• Streamline your business with a content production plan that eliminates guesswork, wasted time, and money.
How to Use AI to Write a High-Quality Article that Ranksminatamang0021
In the world of content creation, many AI bloggers have drifted away from their original vision, resulting in low-quality articles that search engines overlook. Don't let that happen to you! Join us to discover how to leverage AI tools effectively to craft high-quality content that not only captures your audience's attention but also ranks well on search engines.
Disclaimer: Some of the prompts mentioned here are the examples of Matt Diggity. Please use it as reference and make your own custom prompts.
Top 3 Ways to Align Sales and Marketing Teams for Rapid GrowthDemandbase
In this session, Demandbase’s Stephanie Quinn, Sr. Director of Integrated and Digital Marketing, Devin Rosenberg, Director of Sales, and Kevin Rooney, Senior Director of Sales Development will share how sales and marketing shapes their day-to-day and what key areas are needed for true alignment.
How to Run Landing Page Tests On and Off Paid Social PlatformsVWO
Join us for an exclusive webinar featuring Mariate, Alexandra and Nima where we will unveil a comprehensive blueprint for crafting a successful paid media strategy focused on landing page testing.With escalating costs in paid advertising, understanding how to maximize each visitor’s experience is crucial for retention and conversion.
This session will dive into the methodologies for executing and analyzing landing page tests within paid social channels, offering a blend of theoretical knowledge and practical insights.
The Pearmill team will guide you through the nuances of setting up and managing landing page experiments on paid social platforms. You will learn about the critical rules to follow, the structure of effective tests, optimal conversion duration and budget allocation.
The session will also cover data analysis techniques and criteria for graduating landing pages.
In the second part of the webinar, Pearmill will explore the use of A/B testing platforms. Discover common pitfalls to avoid in A/B testing and gain insights into analyzing A/B tests results effectively.
In this presentation, Danny Leibrandt explains the impact of AI on SEO and what Google has been doing about it. Learn how to take your SEO game to the next level and win over Google with his new strategy anyone can use. Get actionable steps to rank your name, your business, and your clients on Google - the right way.
Key Takeaways:
1. Real content is king
2. Find ways to show EEAT
3. Repurpose across all platforms
Mastering Local SEO for Service Businesses in the AI Era is tailored specifically for local service providers like plumbers, dentists, and others seeking to dominate their local search landscape. This session delves into leveraging AI advancements to enhance your online visibility and search rankings through the Content Factory model, designed for creating high-impact, SEO-driven content. Discover the Dollar-a-Day advertising strategy, a cost-effective approach to boost your local SEO efforts and attract more customers with minimal investment. Gain practical insights on optimizing your online presence to meet the specific needs of local service seekers, ensuring your business not only appears but stands out in local searches. This concise, action-oriented workshop is your roadmap to navigating the complexities of digital marketing in the AI age, driving more leads, conversions, and ultimately, success for your local service business.
Key Takeaways:
Embrace AI for Local SEO: Learn to harness the power of AI technologies to optimize your website and content for local search. Understand the pivotal role AI plays in analyzing search trends and consumer behavior, enabling you to tailor your SEO strategies to meet the specific demands of your target local audience. Leverage the Content Factory Model: Discover the step-by-step process of creating SEO-optimized content at scale. This approach ensures a steady stream of high-quality content that engages local customers and boosts your search rankings. Get an action guide on implementing this model, complete with templates and scheduling strategies to maintain a consistent online presence. Maximize ROI with Dollar-a-Day Advertising: Dive into the cost-effective Dollar-a-Day advertising strategy that amplifies your visibility in local searches without breaking the bank. Learn how to strategically allocate your budget across platforms to target potential local customers effectively. The session includes an action guide on setting up, monitoring, and optimizing your ad campaigns to ensure maximum impact with minimal investment.
5 big bets to drive growth in 2024 without one additional marketing dollar AND how to adapt to the biggest shifting eCommerce trend- AI.
1) Romance Your Customers - Retention
2) ‘Alternative’ Lead Gen - Advocacy
3) The Beautiful Basics - Conversion Rate Optimization
4) Land that Bottom Line - Profitability
5) Roll the Dice - New Business Models
Digital Commerce Lecture for Advanced Digital & Social Media Strategy at UCLA...Valters Lauzums
E-commerce in 2024 is characterized by a dynamic blend of opportunities and significant challenges. Supply chain disruptions and inventory shortages are critical issues, leading to increased shipping delays and rising costs, which impact timely delivery and squeeze profit margins. Efficient logistics management is essential, yet it is often hampered by these external factors. Payment processing, while needing to ensure security and user convenience, grapples with preventing fraud and integrating diverse payment methods, adding another layer of complexity. Furthermore, fulfillment operations require a streamlined approach to handle volume spikes and maintain accuracy in order picking, packing, and shipping, all while meeting customers' heightened expectations for faster delivery times.
Amid these operational challenges, customer data has emerged as an important strategy. By focusing on personalization and enhancing customer experience from historical behavior, businesses can deliver improved website and brand experienced, better product recommendations, optimal promotions, and content to meet individual preferences. Better data analytics can also help in effectively creating marketing campaigns, improving customer retention, and driving product development and inventory management.
Innovative formats such as social commerce and live shopping are beginning to impact the digital commerce landscape, offering new ways to engage with customers and drive sales, and may provide opportunity for brands that have been priced out or seen a downturn with post-pandemic shopping behavior. Social commerce integrates shopping experiences directly into social media platforms, tapping into the massive user bases of these networks to increase reach and engagement. Live shopping, on the other hand, combines entertainment and real-time interaction, providing a dynamic platform for showcasing products and encouraging immediate purchases. These innovations not only enhance customer engagement but also provide valuable data for businesses to refine their strategies and deliver superior shopping experiences.
The e-commerce sector is evolving rapidly, and businesses that effectively manage operational challenges and implement innovative strategies are best positioned for long-term success.
Digital Commerce Lecture for Advanced Digital & Social Media Strategy at UCLA...
18th pharmacovigilance 2019
1. Key Speakers Include
JACKIE ROBERTS
Executive Director Regulatory, Pharmacovigilance and
Medical / QPPV
Accord Healthcare
JABEEN AHMAD
Regional PV Director, EEMEA
Abbvie
SUSAN WELSH
Chief Safety Officer
CSL Behring
RICARDA TIEMEYER
Head of Drug Safety & PoC Medical Information
Roche
MIROSLAVA NOVAKOVA
Medical Advisor
Sanofi Pasteur (Slovak Republic)
CHETAN SHATAPATHY
Principal Pv Physician
AstraZeneca
YUUNG YUUNG YAP
Senior International Regulatory Counsel, EU and
International Regulatory Law
Pfizer
DAVID JEFFERYS
Sr. VP Regulatory
Eisai
TANJA PETERS
Global Head of PV Intelligence, Deputy EU QPPV
Boehringer Ingelheim
JOHN SOLOMON
Head of Pharmacovigilance - UK & Ireland
Sanofi
VINEET KACKER
Co-Founder, Global Technical Director and QPPV
APCER Lifesciences
MICHAEL BEAN
Senior Director, Regulatory Compliance R&D
Johnson & Johnson
EMANUEL LOHRMANN
Lead Safety Physician
Boehringer Ingelheim
STEINAR MADSEN
Medical Director
Norweigen Medicines Agency
PHILLIP EICHORN
Senior Director (Worldwide Safety and Regulatory)
Pfizer
DORIS STENVER
Chief Medical Officer, Member of the Pharmacovigilance
Risk Assessment Committee (PRAC)
Danish Medicines Agency
ALEJANDRA PADOVANI
Safety Scientist
Roche
HEINZ WEIDENTHALER
VP, Clinical Strategy, QPPV
Bavarian Nordic
MILIND ANTANI
Leader, Pharma and Healthcare
Nishith Desai Associates (India)
MIRCEA CIUCA
Global Head Medical & Clinical Drug Safety
Vifor Pharma
FRANCK SCHWARTZ
QA Global Inspection, Intelligence Lead - Compliance and
Regulatory Affairs
Novartis
HARIS SHAIKH
Senior Director PV
Orchard Therapeutics
POLINA DOMBURE
Member of the Board
Inpharmatis
ALINA TUDOR
Associate Director, Senior PV Physician/Deputy EUQPPV
Norgine
RAJ BHOGAL
Regulatory Inspection Lead, Safety & International Global
Quality
Takeda
Plus many more COMING SOON.....
Organized by
18th Pharmacovigilance 2019
27th & 28th February 2019,
Pestana Chelsea Bridge Hotel,
London, UK
“Ensuring safer drugs to market by analyzing latest developments in
pharmacovigilance, drug safety and risk management”
29 Gary Court,
189 London Road,
Croydon,
Surrey CR0 2DR
+44-2036120886
info.uk@virtueinsight.com
AGENDA
AT A GLANCE
#VIphv
30+
Speakers
70%
Pharma
/ Biotech
6+
Hours of
Networking
2
Days
1
Golden
Opportunity
www.virtueinsight.com
WHO ATTENDS?
Day One
Day Two
Floor Plan
Booking Details
Conference Info
Key Speakers
2. “Conference was very informative & added much knowledge
about Pharmacovigilance systems, ADE, process flow of
reporting, searching data & mobile networking”
Asst. Manager Regulatory Affairs, Emcure
Pharmaceuticals
Organized by
18th Pharmacovigilance 2019
27th & 28th February 2019,
Pestana Chelsea Bridge Hotel,
London, UK
“Ensuring safer drugs to market by analyzing latest developments in
pharmacovigilance, drug safety and risk management”
29 Gary Court,
189 London Road,
Croydon,
Surrey CR0 2DR
+44-2036120886
info.uk@virtueinsight.com
AGENDA
AT A GLANCE
SUPPORTED BY
GOLD SPONSOR
BRONZE SPONSOR
Day One
Day Two
Floor Plan
Booking Details
Conference Info
Key Speakers
3. CONFERENCE INTRODUCTION:-
Global pharmacovigilance market is expected to reach USD 5.51 billion by 2020, according to a new study by Grand View Research, Inc. Increasing incidence rates of adverse
drug reaction and the introduction of stringent drug safety regulations are some key drivers of this market. ADR is responsible for approximately 5% of the hospitalization in
developed countries annually, and this is expected to boost usage rates over the next six years. Pharmacovigilance has witnessed a significant rise in usage rates in the recent
times owing to growing global geriatric population triggering a growth in demand for new drug development. Additionally, health regulatory authorities such as the U.S. FDA
and EMEA (European Medicines Agency) are now emphasizing on electronic submission of data which is also expected to drive the pharmacovigilance market.
BREXIT’s another big issue is medicines. Every month the UK exports 45 million packs of medicines to the EU and EEA countries, and imports more than 37 million. Again,
prolonged disruption at borders could threaten supplies of drugs and other vital healthcare products – both in the UK and elsewhere in Europe. There is more scope with
medicines than with food to increase stocks of things like tablets, but other imported drugs such as insulin often need to be refrigerated and may therefore pose bigger logistical
challenges.
18th Annual Pharmacovigilance 2019 will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues
of the industry. The entire program will cover the detection, analysis and prevention of adverse drug reactions. It will be studied with the help of case studies and industry
experiences. This conference will help the drug safety representatives from the pharmaceutical industry and academic and quality research organisations who wish to under-
stand how to avoid common deficiencies in inspections by learning from the experiences of others; to gain a greater understanding of new and existing pharmacovigilance
requirements, and to improve their organisations’ compliance with pharmacovigilance requirements. Also it can help you control your product’s lifecycle, your patient’s trust,
and your revenue. Hence, this conference will provide an important platform for pharmacovigilance stakeholders to discuss and share best practices in expediting pharma-
covigilance development.
It gives me great pleasure in welcoming all of you to the Virtue Insight’s 18th Pharmacovigilance 2019. I wish and pray that all our efforts will be beneficial to our industries
and to our country at large.
AN EVENT TO VOW
18th Pharmacovigilance 2019 – “Latest developments in pharmacovigilance,
drug safety and risk management”
Get more from the event, with a broader scope bringing the whole communica-
tions value chain together. Enjoy and make the best out of our dedicated network-
ing drinks time, meet the leading international vendors showcasing the products
of tomorrow in the co-located exhibition. Expand your knowledge of the latest
business models and strategies in the high-level conference. Whether you are on
the branded or generic side, you cannot afford to miss this opportunity to bench-
mark your tactics and strategies against the industry leaders who will be the first
to traverse the pathway. Devise an immediate action plan for your biosimilar
prosecution and litigation strategies in light of the barriers to entry, research and
development costs, and regulatory hurdles, which are balanced against an enor-
mous potential for increased profit margins.
KEY THEMES DISCUSSED IN THIS CONFERENCE:-
• Brexit Implications for the UK Pharmaceutical (pharmacovigilance) Industry
• What would ‘no deal’ mean for medicine?
• New Technologies in Pharmacovigilance (AI/ Machine Learning, IoT)
• Quality, Safety and Signal Detection - Future of 2020
• PV Audit & Inspections – Knowing what is to be done
• Drug safety work in the pre-clinical/clinical transition and early clinical
development phase
• Pharmacovigilance in 2020 - future horizons and efficiencies
• Updates towards of legislation, policies, systems, technology, communication
strategies and best practice in PV
• Possible effects of Brexit on Pharmacovigilance
• Benefit/Risk ratio: the common denominator
• Market analysis – What is our current stand? – Moving towards the new
successful PV era
• PV – Risk Management and Planning
• Risk management in the lifecycle of a drug
• Examining developments in GVP measures and status of the new Module VI
• Improving in signal management and their implications
• Latest updates and hot topics relating to the role of the QPPV
• Challenges and Opportunities to optimize the overall PV ecosystem for
maximum benefit
• Quality, Safety and Signal Detection - Future of 2020
• Medical devices – Increasing safety perspective
• Case studies from various countries on the PV frameworks around the world
• Good Clinical Practices and Good Pharmacovigilance practices
• Proper communication - Sponsor – Site – CRO & Patients
• Patient centric approach to help improve patient safety
• Outsourcing activities - How to set it right?
• How to involve patients better to develop drugs
• The developing regulatory framework in advanced and developing markets – EU,
USA & ROW
• Accelerating new medicine introduction in developing world & overcoming
challenges
• Be part of a major networking opportunity
WHY EXHIBIT?
Make Sales
Debut new products
Profile your brand
Meet new business partners
Develop key relationships
Educate pharma and biotech companies
WHO WILL YOU MEET
CEO’s, CTO’s, CIO’s, Presidents, VPs, Directors, Heads, Managers, Scientific Advisors, Consultants of:
Pharmacovigilance, Pharmacoepidemiology, Pharmacogenomics, Drug/Product Safety, Drug Development, Information and Clinical Data Management, Clinical Pharmacol-
ogy, Clinical Safety, Periodical safety update Reports, Risk Management, Research & Development, Quality Assurance, Patient Safety, Signal Detection, Safety Surveillance,
Outcomes Research, Data Analysis, Epidemiology, Medical Affairs, Regulatory Affairs and Compliance, Information technology, Sales and Marketing
“Panel discussions are very interactive as well as address real
world and practical issues”
Head – Medical Affairs, Wockhardt
Organized by
18th Pharmacovigilance 2019
27th & 28th February 2019,
Pestana Chelsea Bridge Hotel,
London, UK
“Ensuring safer drugs to market by analyzing latest developments in
pharmacovigilance, drug safety and risk management”
29 Gary Court,
189 London Road,
Croydon,
Surrey CR0 2DR
+44-2036120886
info.uk@virtueinsight.com
AGENDA
AT A GLANCE
Key Speakers
Conference Info
Booking Details
Floor Plan
Day Two
Day One
4. DAY ONE - 27th February 2019
Organized by
18th Pharmacovigilance 2019
27th & 28th February 2019,
Pestana Chelsea Bridge Hotel,
London, UK
“Ensuring safer drugs to market by analyzing latest developments in
pharmacovigilance, drug safety and risk management”
29 Gary Court,
189 London Road,
Croydon,
Surrey CR0 2DR
+44-2036120886
info.uk@virtueinsight.com
AGENDA
AT A GLANCE
“Very good platform to meet other pharmacovigilance expertise
and interact with them about the advances & opportunites in
pharmacovigilance. Virtue Insights is really good at coordinat-
ing and organizing”
Safety Physician, Sciformix
CHALLENGES & OPPORTUNITIES
11:50 Keynote Panel Discussion: Optimising the PV
ecosystem for betterment
• Discuss on the possible impacts of Brexit
• Staying ahead in the race - Update on PV in EU, USA & RoW -
Current trends for PV, and new and future guidelines
• Pharmacy practice and its guidelines
• Future Drivers for Pharmacovigilance
• New ways to generate evidence including real world evidence
• The role of social media
• Best practices
Moderator:
SUSAN WELSH
Chief Safety Officer
CSL Behring
Panellists:
JABEEN AHMAD
Regional PV Director, EEMEA
Abbvie
CHETAN SHATAPATHY
Principal Pv Physician
AstraZeneca
TANJA PETERS
Global Head of PV Intelligence, Deputy EU QPPV
Boehringer Ingelheim
12:30 – Networking luncheon
QUALITY - SAFETY – SIGNAL DETECTION
13:50 Panel Discussion – Quality, Safety and Signal
Detection - Future of 2020
• Strategies for best practice in Signal Detection
• PRAC signal recommendations
• PSUR and PSUSA recommendations
• How should we approach?
• Using technology to enhance interactive connection with
patients
• Statistical signal detection as a routine pharmacovigilance
practice
• Latest updates and hot topics
Moderator:
SUSAN WELSH
Chief Safety Officer
CSL Behring
08:30 – Coffee and registration – An opportunity to meet and to
network with your conference colleagues.
09:30 SUSAN WELSH
Chief Safety Officer
CSL Behring
Chairperson opening remarks
MARKET TRENDS & WAY FORWARD
09:40 JABEEN AHMAD
Regional PV Director, EEMEA
Abbvie
Pharmacovigilance in Emerging Markets: Inspiration Challenge
Initiatives to build PV capacity in emerging markets have resulted
in an explosion of global PV legislation. This session will examine
the triggers for this dynamic change. The session will provide an
overview of PV capacity building with a global overview of the
regulatory landscape, and the triggers for change. We will evalu-
ate the challenges for pharmaceutical companies and regulatory
agencies, and highlight the need for “right-size” PV systems. The
session will also highlight the ways in we can speak with one
industry voice in this fast-paced environment.
10:20 CHETAN SHATAPATHY
Principal Pv Physician
AstraZeneca
PV Audit & Inspections – Knowing what is to be done
• Data Quality Management and Analysis
• PV Inspection readiness: What to expect? How ready can we
be?
• Risk based selection criteria for auditing
• Methodologies, scope and oversight
• Preparing and managing safety data exchange agreements
• Relationship to other GxPs
10:50 – Morning Coffee/Tea & Discussion
11:20 VINEET KACKER
Co-Founder, Global Technical Director and QPPV
APCER Lifesciences
Risk management in the lifecycle of a drug
Day One
Day Two
Floor Plan
Booking Details
Conference Info
Key Speakers
5. DAY ONE - 27th February 2019
NETWORKING DRINKS
Meet with your industry peers for a
relaxed drink at the end of day one
Organized by
18th Pharmacovigilance 2019
27th & 28th February 2019,
Pestana Chelsea Bridge Hotel,
London, UK
“Ensuring safer drugs to market by analyzing latest developments in
pharmacovigilance, drug safety and risk management”
29 Gary Court,
189 London Road,
Croydon,
Surrey CR0 2DR
+44-2036120886
info.uk@virtueinsight.com
AGENDA
AT A GLANCE
“Very well organized and the sessions were so well placed. Got
enough time for networking and well time managed”
Country Safety Lead, Pfizer Limited
Panellists:
EMANUEL LOHRMANN
Lead Safety Physician
Boehringer Ingelheim
ALEJANDRA PADOVANI
Safety Scientist
Roche
FRANCK SCHWARTZ
QA Global Inspection, Intelligence Lead - Compliance and
Regulatory Affairs
Novartis
MIRCEA CIUCA
Global Head Medical & Clinical Drug Safety
Vifor Pharma
14:30 DORIS STENVER
Chief Medical Officer, Member of the Pharmacovigi
-lance Risk Assessment Committee (PRAC)
Danish Medicines Agency
PRAC activities update
15:00 POLINA DOMBURE
Member of the Board
Inpharmatis
Automation and Centralisation of Local Literature Search in
Pharmacovigilance: Prudenta
• Why should we automate and centralise
• How Prudenta makes this task easy
• What are the key benefits of Artificial Intelligence in PV
15:20 – Afternoon Tea/Coffee
15:50 JOHN SOLOMON
Head of Pharmacovigilance - UK & Ireland
Sanofi
Post approval risk minimisation challenges and solutions
• Risk minimisation as a key objective for the safer use of
medicines by patients.
• Effective pharmacovigilance can positively impact public
safety and perception.
• Multi-factorial and innovational considerations are critical to
achieve success in this evolving discipline.
IMPACT OF TECHNOLOGY
16:20 MIRCEA CIUCA
Global Head Medical & Clinical Drug Safety
Vifor Pharma
New technologies in Pharmacovigilance
• Artificial intelligence/Machine learning in Pharmacovigilance
• Can PV keep up with the pace of innovation?
• Are stakeholders and PV systems ready to embrace AI?
• Information technology in pharmacovigilance
• Decision process
• Conclusions / Discussion
16:50 – Chairperson’s closing remarks and end of conference
17:00 - 18:00 Networking Drinks - Take your discussions
further & build new relationships in
a relaxed & informal setting
FOR DELEGATE REGISTRATIONS:-
Our potent conference agenda delivering the latest information
and the world class leaders as speakers attract delegates to attend
from around the world. We aim for our attendees to be equipped
with knowledge of latest developments & enable them to network
with the industry key personnel.
Delegate Registration - delegate.uk@virtueinsight.com
Day One
Day Two
Floor Plan
Booking Details
Conference Info
Key Speakers
6. DAY TWO - 28th February 2019
Organized by
18th Pharmacovigilance 2019
27th & 28th February 2019,
Pestana Chelsea Bridge Hotel,
London, UK
“Ensuring safer drugs to market by analyzing latest developments in
pharmacovigilance, drug safety and risk management”
29 Gary Court,
189 London Road,
Croydon,
Surrey CR0 2DR
+44-2036120886
info.uk@virtueinsight.com
AGENDA
AT A GLANCE
“Informative session focusing on new and grey areas of Phar-
macovigilance patient care being the utmost priority on minds
of all the pharma company new aspect discussion and light
on the grey areas had open new arena for Pharmacovigilance
thank you”
Drug Safety Associate, Cipla
08:30 – Coffee and registration – An opportunity to meet and to
network with your conference colleagues.
09:30 SUSAN WELSH
Chief Safety Officer
CSL Behring
Chairperson opening remarks
PV FOR 2020
09:40 EMANUEL LOHRMANN
Lead Safety Physician
Boehringer Ingelheim
Monitoring of additional risk management measures.
• Assessing effectiveness of risk minimisation measures is
essential to gain feedback to justify existing approach, or to
direct steps to improve risk management measures
• Process parameters, behavioural and safety outcomes in focus
of monitoring of risk minimisation measures
• Both quality of the collected information and time to collect
such information are essential
PATIENT SAFETY
10:20 PHILLIP EICHORN
Senior Director (Worldwide Safety and Regulatory)
Pfizer
Safety/PV considerations in Patient Support Programmes and
Market Research Programmes
• What types of programmes can generate reportable safety
information?
• How useful are these data?
• Can we manage/mitigate risk of unintentionally stimulating
such information?
• How to promote quality of safety-related information from
these programmes
10:50 – Morning Coffee/Tea & Discussion
11:10 HARIS SHAIKH
Senior Director PV
Orchard Therapeutics
Risk management for advanced therapy medicinal products
(ATMPs)
• An introduction to ATMPs
• Global differences and similarities in the risk management
(RM) legislations for ATMPs
• Identification of the Safety and Efficacy Risks for ATMPs
• Pragmatic Risk Management Approach
• PV and risk minimisation measures
SPONSOR – SITE – CRO - PATIENTS
11:50 Keynote Panel Discussion – Proper communication -
Sponsor – Site – CRO & Patients
• Maintaining relationships: Sponsor – Site – CRO & Patients
• Tips for improving communication between sponsors and
CROs
• How Improved communications could change the clinical
research industry
• Importance of patients involvement in the communication
• Communication - Best practices
• Training and Preparedness
• Considerations for good PV outsourcing practices
Moderator:
SUSAN WELSH
Chief Safety Officer
CSL Behring
Panellists:
MIROSLAVA NOVAKOVA
Medical Advisor
Sanofi Pasteur (Slovak Republic)
HEINZ WEIDENTHALER
VP, Clinical Strategy, QPPV
Bavarian Nordic
HARIS SHAIKH
Senior Director PV
Orchard Therapeutics
12:30 – Networking luncheon
RISK MANAGEMENT & PLANNING
13:30 Panel Discussion – PV – Risk Management and
Planning
• Implementation and maintenance of RMP’s – Overcoming its
challenges
• Risk management in different jurisdictions
• Risk communication: Interface between pharmacovigilance,
sales and marketing
• Benefit/Risk ratio: the common denominator
• How effective is your risk management
• New approaches to managing benefit-risk
• Updating signal management processes in big pharma
• GDPR and data privacy with regards to EU regulations
Moderator:
SUSAN WELSH
Chief Safety Officer
CSL Behring
Day One
Day Two
Floor Plan
Booking Details
Conference Info
Key Speakers
7. DAY TWO - 28th February 2019
Organized by
18th Pharmacovigilance 2019
27th & 28th February 2019,
Pestana Chelsea Bridge Hotel,
London, UK
“Ensuring safer drugs to market by analyzing latest developments in
pharmacovigilance, drug safety and risk management”
29 Gary Court,
189 London Road,
Croydon,
Surrey CR0 2DR
+44-2036120886
info.uk@virtueinsight.com
AGENDA
AT A GLANCE
“Very nice opportunity to share current challenges
within its own organisation with other Pharmacovigi-
lance agents and hear about future initiatives to make
our contribution to PV, safety, more efficiently moving
forward.”
Associate Director, Pharmacovigilance Operations,
INCYTE Biosciences International
Panellists:
RICARDA TIEMEYER
Head of Drug Safety & PoC Medical Information
Roche
MICHAEL BEAN
Senior Director, Regulatory Compliance R&D
Johnson & Johnson
VINEET KACKER
Co-Founder, Global Technical Director and QPPV
APCER Lifesciences
14:10 STEINAR MADSEN
Medical Director
Norweigen Medicines Agency
Why does pharmacovigilance sometimes fail and where could
the fault lie?
• Risk blindness - industry or drug authorities?
• It’s not my fault – but whom to blame?
• Hard to detect adverse reactions
• Do we learn from previous experiences?
REGULATION OVERVIEW & UPDATE
14:50 Panel Discussion: PV - Regulatory Updates
• Key current changes and their impact on current PV
• Impact of Brexit – Regulatory aspect
• Pharmacovigilance and the role of regulatory affairs: How to
achieve compliance across the business
• Future Legislation: Pharmacovigilance – Industry Vision
• PV System Legislation Updates
• Current PV practices in the EU & US
• Enhancing communication between regulators, regional
authorities and patients
Moderator:
MILIND ANTANI
Leader, Pharma and Healthcare
Nishith Desai Associates (India)
Panellists:
JACKIE ROBERTS
Executive Director Regulatory, Pharmacovigilance and Medical
/ QPPV
Accord Healthcare
DAVID JEFFERYS
Sr. VP Regulatory
Eisai
YUUNG YUUNG YAP
Senior International Regulatory Counsel, EU and International
Regulatory Law
Pfizer
RAJ BHOGAL
Regulatory Inspection Lead, Safety & International Global
Quality
Takeda
15:40 – Afternoon Tea/Coffee
16:00 ALINA TUDOR
Associate Director, Senior PV Physician/Deputy
EUQPPV
Norgine
Outsourcing activities - How to set it right?
• Outsourcing PV: How to be easily ready for a quick upscaling
in the portfolio, without jeopardizing safety
• Safety Database outsourcing: one model fits all?
• Risk-benefit evaluation: how best can this be outsourced?
• Secret recipe for a successful relationship between the MAHs
and the PV vendors
16:30 - 16:40 – Chairperson’s closing remarks and end of the
conference
FOR SPONSORSHIP OPPORTUNITIES:-
Sponsorship or exhibition is the best way to speed network with decision
makers. The world leader speakers in our conferences attract niche delegates
from all over the world. This would be a wonderful opportunity to reach the
right audience and save money and time on all your other advertising gim-
micks. To give you an advertising edge we constantly update the industry
pioneers via emails/news letter about the event and advertise the event via
different forms of media.
Sponsorship Enquires - sponsor.uk@virtueinsight.com
Day One
Day Two
Floor Plan
Booking Details
Conference Info
Key Speakers
8. FLOOR PLAN - Book your stalls now before they run out !!!
Note :- The floorplan is subject to change at the discretion of the organisers.
REGISTRATION
DESK CONFERENCE HALL
Exhibition Area
Coffee / Tea / Networking Area
1 2
7 6 5
48
1
2
3
4
5
6
7
8
3
Organized by
18th Pharmacovigilance 2019
27th & 28th February 2019,
Pestana Chelsea Bridge Hotel,
London, UK
“Ensuring safer drugs to market by analyzing latest developments in
pharmacovigilance, drug safety and risk management”
29 Gary Court,
189 London Road,
Croydon,
Surrey CR0 2DR
+44-2036120886
info.uk@virtueinsight.com
AGENDA
AT A GLANCE
“This conference was very good for the pharmacovigilance
professionals as well as business people. Organising this
event and the event management was nicely done by
Virtue Insight”
IT Administrator, Oviya Med Safe Pvt. Ltd
Day One
Day Two
Floor Plan
Booking Details
Conference Info
Key Speakers
9. For Multiple Bookings - Photocopy this form and send it to delegate.uk@virtueinsight.com; Tel:+44 2036120886
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TERMS AND CONDITIONS:
Payment terms: Virtue Insight requires the full amount to be paid before
the conference. We may refuse entry to delegates who have not paid
their invoice in full.
Cancellations: Delegates and vendor are subject to the following charges
and refunds upon withdrawal or cancellation.Between 2-3 month’s prior
75% cancellation fee/ 25% refund.Less than 2 months prior to the event
Full cancellation fee / No refund.
Administration Fee: If you cancel your participation (once confirmed)
and haven’t paid the attendance fee you will be liable to pay an admin-
istration fee of £200 + VAT
Substitutions/Name Change: If you are unable to attend you may nom-
inate, in writing, another delegate to take your place at any time prior to
the start of the event. This can be done at not extra cost.
Presentation: If you cannot attend the conference, you can still purchase
the presentations for £400 + VAT
Indemnity: Virtue Insight reserves the right to make alterations to the
conference/executive briefing content, timing, speakers or venue with-
out notice. The event may be postponed or cancelled due to unforeseen
events beyond the control of Virtue Insight. If such a situation arises, we
will refund your registration fee and we will try to reschedule the event.
Fee: The conference fee includes lunch, refreshments and conference
papers provided on the day. This fee does not include travel or hotel
accommodation.
Special Offer:
VENUE
Pestana Chelsea Bridge Hotel
Address: 354 Queenstown Rd,
London SW8 4AE, UK
Phone: +44 20 7062 8000
MAP & DIRECTIONS
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HERE
for more details
Organized by
18th Pharmacovigilance 2019
27th & 28th February 2019,
Pestana Chelsea Bridge Hotel,
London, UK
“Ensuring safer drugs to market by analyzing latest developments in
pharmacovigilance, drug safety and risk management”
29 Gary Court,
189 London Road,
Croydon,
Surrey CR0 2DR
+44-2036120886
info.uk@virtueinsight.com
AGENDA
AT A GLANCE
“The conference was interesting and was a good platform
for networking. The audience and the panelists were
from varying backgrounds giving an insight to various
challenges being faced by the Indian industry”
Manager - BD, ELC Research
Day One
Day Two
Floor Plan
Booking Details
Conference Info
Key Speakers