This document provides information about the 6th Annual Pharmacovigilance Conference taking place on March 16-17, 2011 in London. The conference will discuss the latest developments in pharmacovigilance, drug safety, and risk management. It will feature keynote speakers from organizations like Pfizer, Abbott Laboratories, and Novartis. Sessions over the two days will cover topics like benefit-risk assessments, signal detection methodologies, pharmacovigilance during clinical trials, and the transition between pre- and post-marketing safety. The conference is aimed at professionals in fields like pharmacovigilance, drug development, clinical safety, and regulatory affairs.
Reasons to register today:
• Understand the use of isothermal calorimetry to characterise stability of amorphous pharmaceuticals
• Implement the latest technological developments
• Discuss the best approaches to control and stabilise amorphous drug forms
• Examine the quantification of amorphous content
• Gain a clearer insight on amorphous food materials
• Seize this opportunity to network with leaders from pharma-biotech, healthcare and regulatory agencies
Reasons to register today:
• Understand the use of isothermal calorimetry to characterise stability of amorphous pharmaceuticals
• Implement the latest technological developments
• Discuss the best approaches to control and stabilise amorphous drug forms
• Examine the quantification of amorphous content
• Gain a clearer insight on amorphous food materials
• Seize this opportunity to network with leaders from pharma-biotech, healthcare and regulatory agencies
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
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.
This is a conference about drug discovery and drug development. G protein-coupled receptor (GPCR) and protein kinases are the biggest drug targets in medicine. Around half of all drugs, for whatever disease, work by interacting with different GPCRs and kinases.
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.
A generic medicine contains the same active ingredient as the originators product on which it is based and as such is interchangeable with this originators. It offers the same high quality and efficacy, together with affordability. In theory, dosage, indications, cons-indications, side effects and safety guarantees are the same.
The concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004 and came into effect in 2005. The first biosimilar medicine was approved by the European Commission in 2006.
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
Biopharmaceuticals are an essential therapeutic option accounting for a substantial part of the global therapeutic market. With the patents of many blockbuster drugs coming to an end, an opportunity has arisen for the manufacture and approval of biosimilars. Visiongain\'s 9th Biosimilars Conference will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects.
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.
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
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.
This is a conference about drug discovery and drug development. G protein-coupled receptor (GPCR) and protein kinases are the biggest drug targets in medicine. Around half of all drugs, for whatever disease, work by interacting with different GPCRs and kinases.
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.
A generic medicine contains the same active ingredient as the originators product on which it is based and as such is interchangeable with this originators. It offers the same high quality and efficacy, together with affordability. In theory, dosage, indications, cons-indications, side effects and safety guarantees are the same.
The concept of a “similar biological medicinal product” was adopted in EU pharmaceutical legislation in 2004 and came into effect in 2005. The first biosimilar medicine was approved by the European Commission in 2006.
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
Biopharmaceuticals are an essential therapeutic option accounting for a substantial part of the global therapeutic market. With the patents of many blockbuster drugs coming to an end, an opportunity has arisen for the manufacture and approval of biosimilars. Visiongain\'s 9th Biosimilars Conference will look at the multiple facets of biosimilars, ranging from the evolving regulatory landscape and challenges in clinical development, to the legal and economic aspects.
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.
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
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.
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
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.
Similar to 6th annual pharmacovigilance conference (2011) (20)
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
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Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
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Contents of Memorandum of Association:
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Registered Office Clause: It specifies the location where the company's registered office is situated. This office is where all official communications and notices are sent.
Objective Clause: This clause delineates the main objectives for which the company is formed. It's important to define these objectives clearly, as the company cannot undertake activities beyond those mentioned in this clause.
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Legal Requirement: The MOA is a legal requirement for the formation of a company. It must be filed with the Registrar of Companies during the incorporation process.
Constitutional Document: It serves as the company's constitutional document, defining its scope, powers, and limitations.
Protection of Members: It protects the interests of the company's members by clearly defining the objectives and limiting their liability.
External Communication: It provides clarity to external parties, such as investors, creditors, and regulatory authorities, regarding the company's objectives and powers.
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Amendment of MOA:
While the MOA lays down the company's fundamental principles, it is not entirely immutable. It can be amended, but only under specific circumstances and in compliance with legal procedures. Amendments typically require shareholder
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1. 6th Annual
Pharmacovigilance
Examining latest developments in pharmacovigilance, drug safety and risk
management to ensure safer drugs to market
16th - 17th March 2011, Thistle City Barbican, London, UK BOOK NOW!
Key Speakers
Dr. Doris I. Stenver, Chief Medical Officer EU Pharmacovigilance, Working Party Delegate, Danish Medicines Agency
Dr. William Gregory, Senior Director, Safety & Risk Management, Pfizer
Dr. Sandip Chaudhuri, Director and Safety Risk Management Lead, Pfizer
Dr. Vicki Edwards, Director, European Pharmacovigilance, Abbott Laboratories
Rashmi Hegde, Director Pharmacovigilance, Abbott Products
Dr. Ute Hoeffner, EU QPPV, Novartis Consumer Health GmbH
Dr. Julia Appelskog, Drug Safety Manager, Johnson & Johnson
Sandeep Bhat, Global Director, Life Sciences and Solutions Head, Matured Markets, MphasiS an HP
Dr. Sumit Munjal ,Consultant Physician - UK (Global) Pharmacovigilance, Johnson & Johnson
Dr. William C Maier, Vice President, Epidemiology/Drug Safety/Risk Management, Registrat-Mapi
Rishi Kiran Chopra, Senior Safety Advisor, GlaxoSmithKline
Dr. Anil K Dhiri, Senior Consulting Technical Manager, Oracle Health Sciences
Véronique Basch, Executive Director, Safety Europe, United Biosource Corporation
Paul Murphy, Healthcare Business Manager, Gael Ltd
Associate Sponsor
Driving the Industry Forward | www.futurepharmaus.com Organised By
Media Partners
To Book Call: +44 (0) 20 7336 6100 | www.visiongain.com/pharmacovigilance
2. Conference Introduction
6th Annual Pharmacovigilance
16th - 17th March 2011, London, UK
Dear Colleague, Associate Sponsor:
rug safety has long been an issue however the concern has risen again in recent years
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isiongain’s 6th Annual Pharmacovigilance Conference is designed to bring together
V
exclusive panel of experts who will discuss various aspects of pharmacovigilance practices
in clinical trails, risk management and drug safety. The conference will feature keynote Media Partners:
addresses on reporting, auditing & inspection, technical advances for the betterment of PharmiWeb.com is the leading industry-sponsored portal for
pharmacovigilance practices, live-licensing and pharmacovigilance in Europe, US and Asia. the pharmaceutical sector. Supported by most of the leading
Whether your interests lie in drug safety, risk management or pharmaceutical corporations, PharmiWeb.com provides dynamic real-time news,
features, events listings and international jobs to industry professionals across Europe
pharmacovigilance, attending this conference will enable you to:
and the US.
• ain insight about the global pharmacovigilance landscape today and perspectives
G
on the future
For further information please email: corporate@pharmiweb.com
• Understand pharmacovigilance during the pre-approval phases BIOTECHNOLOGY EUROPE is owned by BIOTECHNOLOGY
WORLD. It is based and located in Warsaw, Poland.
• Develop pharmacovigilance in clinical trials
Biotechnology World was founded in 2007 to provide the world’s biotech and pharma
• Explore risk management plans: are they a tool for improving drug safety? information and market to make it universally accessible and useful for scientific
• Assess post marketing safety strategy and business processes. Its first step to fulfilling that mission was building the
• Implement new statistical tools for monitoring the safety of marketed drugs BIOTECHNOLOGY EUROPE platform that will allow a quick spread of information in
• Examine advances in inspection, reporting and auditing different channels. BIOTECHNOLOGY EUROPE offers companies completed internet
• Learn signal detection methodologies to support effective safety management public relations, publication and marketing solutions. One of the mains goals of
BIOTECHNOLOGY EUROPE is to integrate the Biotech and Pharma Sector in Europe to
• Make the most of inspections and best practices in maintaining constant vigilance global biotechnology, pharmaceutical and life science activities.
• eview current principles and practices of regulatory pharmacovigilace in Europe and US
R For further information please visit: www.biotechnology-europe.com
• Improve pharmacovigilance in Asia
Future Pharmaceuticals has forged powerful relationships
Driving the Industry Forward | www.futurepharmaus.com
• Hear about role of Live-Licensing/In-Life Testing in drug development with key industry leaders to provide a platform for successful
• Evaluate role of electronic data capture in clinical trails brand recognition, and for senior decision-makers to have the means to procure and
• tay ahead by learning advances in computing and electronic communications in
S plan implementation strategies based on the topics covered. Positioned to be an
pharmacovigilance authoritative resource within top pharma companies as well as small, specialty, and
• vercome challenges in pharmacovigilance for orphan, rare indications and biosimilars
O biotech, Future Pharmaceuticals magazine is geared to create a deep penetration into
• Be part of a major networking opportunity a highly targeted and responsive audience, bridging the gap between the industries’
top issues and the solutions top-tier vendors can provide.
I look forward to meeting you at the conference
Best regards For further information please visit: www.futurepharmaus.com
InPharm is the online platform for exclusive pharmaceutical
news, comment, contracts, services, jobs and events and is
home to InPharmjobs.com, Pharmafile and Pharmafocus.
Sonia Tomar For further information please visit: www.In-Pharm.com
Conference Producer
Who will attend? Sponsorship and exhibition opportunities
VP’s, Directors, Heads, Managers, Scientific Advisors, Consultants of:
• Pharmacovigilance This event offers a unique opportunity to meet and do business with some
• Pharmacoepidemiology of the key players in the pharmaceutical and biotech industries. If you have
• Pharmacogenomics
• Drug/Product Safety a service or product to promote, you can do so at this event by:
• Drug Development
• Information and Clinical Data Management • Hosting a networking drinks reception
• Clinical Pharmacology
• Clinical Safety • Taking an exhibition space at the conference
• Periodical safety update report
• Risk Management • Advertising in the delegate documentation pack
• Research & Development
• Quality Assurance • Providing branded bags, pens, gifts, etc.
• Patient Safety
• Signal Detection If you would like more information on the range of sponsorship or exhibition
• Safety Surveillance
• Outcomes Research
possibilities for visiongain's 6th Annual Pharmacovigilance Conference, please
• Data Analysis contact us:
• Epidemiology
• Medical Affairs Ronald Magali, +44 (0)20 7549 9934
• Regulatory Affairs and Compliance
• Information technology ronald.magali@visiongainglobal.com
• Sales and Marketing
1
Gold Sheet, a trade publication on drug quality that analyzes FDA data.
2
Visiongain report: Pharmacovigilance and Other Pharma Regulatory Developments 2010-2020
3. Day 1
6th Annual Pharmacovigilance
Wednesday 16th March 2011
09:00 Registration and refreshments 14:20 Benefit/Risk assessments and striking the right balance
• Developing systems in harmony with regulatory developments
09:30 Opening address from the chair • aintaining constant vigilance and making the best pre and post
M
marketing safety judgements
09:40 The global pharmacovigilance landscape today
• aking accurate determinations of whether a product is in fact safe and
M
and perspectives on the future what can alter the determinations
T
oday we have unprecedented opportunities to understand emerging
Dr. Sandip Chaudhuri
profiles of biopharaceutical products; early understanding keeps patient
Director and Safety Risk Management Lead
safety as the highest priority and at the same time facilitates access to
Pfizer
medicines by patients who need them. This session will provide perspectives
on some of the emerging trends in global pharmacovigilance:
15:00 Afternoon Refreshments
• How have ICH and CIOMS set the stage?
• o more digitised data and new controlled vocabularies inform or add
D 15:20 Discover the benefits of using an electronic
more hay? Quality Management System (QMS) within
• Are there global implications of the new EU legislation?
Pharmacovigilance
Dr. William Gregory T
o illustrate the benefits of an electronic QMS for the Pharmacovigilance
Senior Director, Safety & Risk Management sector, and to demonstrate how the effective management of your
Pfizer compliance processes can turn into a business benefit.
10:20 Audit and Inspection • lectronic QMS ‘v’ Manual System - why should you migrate to an
E
• Making most of inspections electronic version?
• Best practices in maintaining constant vigilance • nalysis & Feedback on Compliance processes - how can it help staff and
A
Senior Management?
Dr. Vicki Edwards
• Ensuring Quality is organisation wide - why and how can this happen?
Director, European Pharmacovigilance
• chieving and maintaining compliance with industry standards/
A
Abbott Laboratories
regulations - how and why an electronic QMS is more cost effective
11:00 Morning refreshments and efficient
Paul Murphy
11:20 Pharmacovigilance during the pre-approval phases: Healthcare Business Manager
an evolving pharmaceutical industry model Gael Ltd
• Pharmacovigilance during pre clinical trails
• Practical pharmacovigilance analysis strategies 15:40 Principles of signal detection
• redicting the clinical relevance of drug interactions from pre-approval studies
P Signals have qualitative and quantitative aspects:
• Methodological aspects of quantitative signal detection
12:00 Key transition between pre and post marketing • Role and approach to qualitative signal detection
safety in the EU D
ifferent categories of adverse effects need different methods for detection
P
eri-approval transition time is key in pharmacovigilance for a smooth C
urrent pharmacovigilance is predominantly based on spontaneous
transition. Activities include the preparation of documents to be provided reporting and is mainly helpful in detecting
together with the application, but also strong planning and preparation • ype B effects (usually unrelated to dosage, serious, unexpected
T
of the post marketing safety system and operations. Challenges remain and unpredictable)
especially for companies performing this transition for the first time. • nusual Type A effects (related to the pharmacological effects and
U
The presentation will focus on: are dosage- related)
• Risk Management Plan E
mploy data mining techniques to analyse large volumes of adverse
• Company Core Safety Information event report data
• Detailed Description of the PV System Other sources of signals:
• QPPV role at transition time • prescription event monitoring
• Post marketing documents and activities: getting operations ready • large automated data resources
Véronique Basch • patient registries
Executive Director, Safety Europe • Case-control surveillance and follow-up studies
United Biosource Corporation Outline of limitations of methodology and data
K
ey messages from the european medicines agency guideline on the uses of
12:40 Networking lunch statistical signal detection methods in the eudravigilance data analysis system
13:40 Risk management plans: are they a tool for Dr. Anila Verma
Director-Drug Safety & Pharmacoepidemiology
improving drug safety?
Amgen
• RMP for an OTC drug - a contradiction?
• RMP upon request of a Health Authority – Who needs to be informed
16:20 Closing remarks from the chair
• Process within the Company, departments involved and responsibilities
• Evaluation and assessment of risk minimisation
Dr. Ute Hoeffner
EU QPPV 16:50 Networking drinks
Novartis Consumer Health GmbH Take your discussions further and build new relationships
in a relaxed and informal setting.
Due to unforeseen circumstances the programme may change and visiongain reserves the right to alter the venue and/or speakers c Copyright visiongain Ltd, 2011
4. Day 2
6th Annual Pharmacovigilance
Thursday 17th March 2011
09:00 Registration and refreshments 13:40 Improving Pharmacovigilance in Asia
• Current status of Asia Pacific regulations relating to Pharmacovigilance
09:30 Opening address from the chair • mportant insights on rapidly evolving Pharmacovigilance regulations
I
in these markets
• ole of Harmonisation in Asian Pharmacovigilance regulations
R
09:40 Strategies to improve pharmacovigilance practices
• trategic challenges in the evolution of Asian Pharmacovigilance
S
• Societal trends with impact on pharmacovigilance
regulations in next decades
• New pharmacovigilance legislation
Rashmi Hegde
• Communication and transparency Director Pharmacovigilance, Asia-Middle East-Australia-Canada
• Stakeholder involvement Abbott Products
Dr. Doris I. Stenver
Chief Medical Officer, EU Pharmacovigilance Working Party Delegate 14:20 Advances in computing and electronic
Danish Medicines Agency communications in pharmacovigilance
Configurable of the Shelf (COTs) vs Customised
10:20 Pharmacovigilance of biopharmaceuticals: • Implication of ICH E2BR3(HL7)
challenges remain • Software as Service (SaaS)
• The importance of pharmacovigilance of biopharmaceuticals • Electronic Health Record
• Challenges to ADR processing during postmarketing and clinical trials • Signals and Data Mining
• Unique aspects of safety concerns T
he presentation will focus on software selection, emerging standards
• To be prepared for the unexpected and importance of electronic health records for signals and data mining.
Additionally, the idea of a “Clearing House” for single case management
Dr. Julia Appelskog
will be floated
Drug Safety Manager
Johnson & Johnson Dr. Anil K Dhiri
Senior Consulting Technical Manager, Oracle Health Sciences
GBU Consulting
11:00 Morning refreshments
15:00 Afternoon refreshments
11:20 Regulatory Pharmacovigilace in Europe current
principles and practice
15:20 The Internet and drug safety: what are the
• uropean Medicines Agency and National competent authorities - role in
E implications for pharmacovigilance?
European Pharmacovigilance
H
ow many use the internet / smart phones / Social Media (S.M),
• ey responsibilities of Committee for Medicinal Products for Human Use
K
and how many access manufacturer information through these
(CHMP) and Pharmacovigilance Working Party (PhVWP)
platforms, how many are pro-digital, anti-digital or not sure)
• arketing authorisation procedures – Centralised/Decentralised/Mutual-
M
• The social media age
recognition/National
• New initiatives • The pharma social media debate
Dr. Sumit Munjal • The implications for pharmacovigilance
Consultant Physician - UK (Global) Pharmacovigilance
• The future of social media in pharma
Johnson & Johnson
Rishi Kiran Chopra
Senior Safety Advisor
12:00 New EU Pharmacovigilance and Risk Management GlaxoSmithKline
Laws in Europe: What you need to do to prepare
• Imminent changes to PV and Risk Management Laws in EU – detail 16:00 Social media consideration within pharmacovigilance
• Likely Impact on Pharmaceutical Companies Dr. Sandeep Bhat
• hat you need to do now and in the future to thrive in the new environment
W Director, Life Sciences
Hewlett-Packard
Dr. William C Maier
Vice President, Epidemiology/Drug Safety/Risk Management
Registrat-Mapi 16:40 Chair’s closing remarks
12:40 Networking lunch 16:50 End of Conference
5. Registration Form
6th Annual Pharmacovigilance
16th - 17th March 2011, London, UK
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