Drug Safety and Pharmacovigilance

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9th International Conference and Exhibition on Pharmacovigilance & Drug Safety

July 17-18, 2017 Munich, Germany 

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products. As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation[2]). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.

Signal detection (SD) involves a range of techniques (CIOMS VIII). The WHO defines a safety signal as: "Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously". Usually more than a single report is required to generate a signal, depending upon the event and quality of the information available.

Data mining pharmacovigilance databases is one approach that has become increasingly popular with the availability of extensive data sources and inexpensive computing resources. The data sources (databases) may be owned by a pharmaceutical company, a drug regulatory authority, or a large healthcare provider. Individual Case Safety Reports (ICSRs) in these databases are retrieved and converted into structured format, and statistical methods (usually a mathematical algorithm) are applied to calculate statistical measures of association. If the statistical measure crosses an arbitrarily set threshold, a signal is declared for a given drug associated with a given adverse event. All signals deemed worthy of investigation, require further analysis using all available data in an attempt to confirm or refute the signal. If the analysis is inconclusive, additional data may be needed such as a post-marketing observational trial.

Organizing Committtee 2017

Dr. Esam Ghanem

CEO Vigi-Care BVBA 

Belgium

Dr.Giovan Giuseppe Mattera

Human Safety, head R&D Sigma tau SpA Italy

Dr.Jorge Gonzalez Borroto

Pharmacovigilance Officer Ferrer Internacional S.A Spain

Roger M. Leblanc

Professor  University of Miami USA

Mirko Diksic

Professor McGill University Canada

Emmanuel O. Akala

Professor Howard University US

Susan Welsh

Chief Safety Officer Sanofi USA

Appu Rathinavelu

Executive Director Rumbaugh-Goodwin Institute for Cancer Research USA

Gamal Hassan A. El-Sokkary

Professor Assiut University Egypt

Mohammed Eddouks

Professor Moulay Ismail University Morocco, Africa

Manish Mahajan

AGM- Medical Affairs Cadila Pharmaceuticals India


Program Schedule

Day 1 July 17, 2017

Forum 15

Opening Ceremony

Keynote Forum

conferenceseries.com 09:30-09:50

09:50-10:00 Introduction
10:00-10:45 Title: Impact of the polypill approach in the efficacy and safety of Trinomia®: Post-

marketing pharmacovigilance data after three-years

Jorge I Gonzalez Borroto, Grupo Ferrer Internacional, Spain
Group Photo 10:45-10:55
Networking & Refreshment Break 10:55-11:15 @ Foyer Ballsaal
11:15-12:00 Title: Risk management life cycle approach – key points
Essam Ghanem, Keyrus Biopharma, Belgium
Sessions: Drug Safety | Pharmacovigilance and Risk Management | Biopharmaceutical Sciences |

Adverse Drug Reaction | Good Pharmacovigilance Practice | Clinical Trials on Various Disorders

Session Chair: Jorge I Gonzalez Borroto, Grupo Ferrer Internacional, Spain

Session Co-Chair: Essam Ghanem, Keyrus Biopharma, Belgium

Session Introduction

12:00-12:35 12:35-13:10

Title: The fundamentals and importance of accurate medical review

Anna Stahl, Otsuka Novel Products GmbH, Germany Title: Brexit and the pharmaceutical industry Aaron D Barzey, ADB Medical, UK

Lunch Break 13:10-14:10 @ Restaurant Grat3

Title: Phytochemical and pharmacological study of volatile fractions from Eucalyptus camaldulensis leaves and their potent effects on isolated aortic and tracheal rings

14:10-14:45 Dlzar A Kheder, University of Zakho, Iraq

Title: Adverse drug reaction: Knowledge and practice of pharmacovigilance by healthcare providers in tertiary institutions in Lagos

14:45-15:20 Temitope Oyeneye, Drug Consult Pharmacy, Nigeria

Title: Inhibition of APP gamma-secretase: A promising tool for improving brain development in Down syndrome and APP-linked brain disorders

15:20-15:55 Fiorenza Stagni, University of Bologna, Italy

16:15-16:50 16:50-17:25

Networking & Refreshments Break 15:55-16:15 @ Foyer Ballsaal

Title: Pharmacovigilant actions of pharmacist on potassium cyanide

Gajendra Singh, Pt. B.D. Sharma University of Health Sciences, India Title: Good pharmacovigilance practice Parminder Kaur, RegPak BioPharma Consulting, Netherlands

Panel Discussion 17:25-18:00

Page 2

Day 2 July 18, 2017

Forum 15

Keynote Forum
09:30-10:15 Title: Is the current analysis of MAHs of ‘off-label use’ constructive?
Anika Staack, MEDICE, Germany
10:15-11:00 Title: Pharmacovigilance in 2020-future horizons and efficiencies in data acquisition,

evaluation and risk management

Flic Gabbay, TranScrip, UK
Networking & Refreshments Break 11:00-11:20 @ Foyer Ballsaal
Sessions: Good Pharmacovigilance Practice | Drug Safety | Pharmacovigilance and Risk Management
Session Chair: Anika Staack, MEDICE, Germany

Session Co-Chair: Flic Gabbay, TranScrip, UK

Session Introduction

11:20-11:55 11:55-12:30

12:30-13:05

PV01

Title: How to ensure high quality output in a constantly changing work environment?

Anika Staack, MEDICE, Germany Title: Efficiency gain in business models for global pharmacovigilance: Automation and

burying the silos

Mandar Kelkar, TranScrip, UK Title: Safepreg papyrus: A scoring system for safer medication use during pregnancy and

the evaluation of 1000 drugs

Gamal Hussein, South College School of Pharmacy, USA

Title: Screening for the postpartum depression among newly delivered women

Jaya Gurung, Al-Ameen College of Pharmacy, India Title: Determining the incidence of potential drug interactions in a general hospital not using

Lunch Break 13:05-14:05 @ Restaurant Grat3
Poster Presentations 14:05 -14:50 @ Meeting Halls
Poster Judge: Essam Ghanem, Keyrus Biopharma, Belgium

computerized prescribing; and assessing the influence on prescribers' actions

PV02 Saed Amarneh, Laniado Hospital, Israel

Title: Evaluating low-dose Aspirin use in diabetic patients

Wijdan H Ramadan, Lebanese American University, Lebanon Sessions: Regulatory Affairs | Biopharmaceutical Sciences | Adverse Drug Reactions

PV03

14:50-15:25 15:25-16:00

16:20-16:55 16:55-17:30

Title: Under-reporting of adverse drug reactions: A problem that also involves medicines subject to additional monitoring. Preliminary data from a single-centre experience on novel oral anticoagulants

Anna Patrignani, Senigallia Hospital, Italy Title: Screening for the postpartum depression among newly delivered women Jaya Gurung, Al-Ameen College of Pharmacy, India

Networking & Refreshments 16:00 -16:20 @ Foyer Ballsaal

Title: Pharmacovigilance and the surveillance of adverse drug reactions

Samira Saleh, Future University, Egypt Title: Overview of pharmacovigilance Mario Adel Barsoum, Ahram Canadian University, Egypt Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products.[1] The etymological roots for the word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy (the condition that this definition only applies with the doses normally used for the prophylaxis, diagnosis or therapy of disease, or for the modification of physiological disorder function was excluded with the latest amendment of the applicable legislation[2]). Medication errors such as overdose, and misuse and abuse of a drug as well as drug exposure during pregnancy and breastfeeding, are also of interest, even without an adverse event, because they may result in an adverse drug reaction.[3]

Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In fact, in order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority. (See Adverse event reporting below.)

Ultimately, pharmacovigilance is concerned with identifying the hazards associated with pharmaceutical products and with minimizing the risk of any harm that may come to patients. Companies must conduct a comprehensive drug safety and pharmacovigilance audit to assess their compliance with worldwide laws, regulations, and guidance.[4] Closing & Award Ceremony

Market Analysis

Market Analysis - Drug Safety 2018

U.S. Pharmacovigilance showcase estimate was esteemed over USD 1 billion of every 2015, and anticipated to witness 10.7% CAGR from 2016 to 2024 to outperform USD 2.5 billion by 2024. Rising death rates attributable to antagonistic medication occasions and developing patient concerns relating to wellbeing and viability of medications will drive industry development. 

Europe Pharmacovigilance advertise estimate was esteemed over USD 793 million of every 2015, with desires to achieve USD 1.8 billion by 2024, seeing 9.9% CAGR from 2016 to 2024, attributable to developing interest for customized drugs and expanding level of rivalry from Biosimilars and generics. 

APAC Pharmacovigilance advertise estimate was USD 835 million of every 2015 and foreseen to surpass USD 2.4 billion by 2024. Developing interest for strict social insurance controls, nearness of immense patient base and expanding number of clinical trials directed on different ailments and Disorders will support provincial Pharmacovigilance piece of the pie. 

Europe was the second biggest buyer of Pharmacovigilance benefits in 2013. Asia Pacific Pharmacovigilance advertise is relied upon to witness the speediest development amid the figure time frame. Accessibility of extensive pool of instructed and financially savvy work drive, the nearness of great business condition and the execution of government activities went for enhancing human services get to are a few variables representing its quick development. Clinical Research Statistics propose that cost related with clinical trials led in the Asia Pacific locale is around half to 70% less expensive than that of trials directed in European nations. 

Russian Pharmacovigilance Market measure is relied upon to surpass USD 8 billion by 2024; as per another examination report by Global Market Insights The Russian pharmaceutical market stays one of the quickest developing on the planet with a normal yearly development rate (from 2008 to 2014) of around 14 rate focuses (pp). 

Consistently Australia spends more on its wellbeing $121.4 billion on wellbeing in 2009-10 which represented 9.4% of aggregate spending on all merchandise and enterprises in the economy. This found the middle value of out to $5479 per individual. As an extent of GDP, Australia spending in 2009 was substantially less than that of the United Sates (17.4%), marginally not as much as the UK (9.8%), New Zeeland (10.3%) and Canada (11.4%) and near the OECD middle (9.6%) 

South Africa's Pharmacovigilance showcase esteemed at USD 37 million Increasing medication reaction and the expansion in ceaseless ailments and clutters is driving the worldwide Pharmacovigilance advertise estimate. An examination provide details regarding worldwide Pharmacovigilance Market Size and may different fields inside the business evaluated Pharmacovigilance Market Size income to be over USD 3 billion of every 2015 and is conjecture to surpass USD 8 billion by 2024; With South Africa's Pharmacovigilance advertise measure assessed over USD 37 million and expected for more than 5% development. 

Spain Pharmacovigilance showcase measure was esteemed over USD 230 million of every 2015 and should witness 10.2% CAGR from 2016 to 2024, to outperform USD 550 million by 2024. Rising interest for new medication improvement, developing geriatric populace and expanding outsourcing by pharmaceutical organizations should fuel territorial industry development. India Pharmacovigilance advertise development was over 14% from 2016 to 2024, and anticipated that would achieve USD 668 million by 2024. Pharmacovigilance showcase anticipated that would achieve a market size of $8 Billion by 2024. 

Contract outsourcing market measure was esteemed over USD 1 billion of every 2015, ready to develop at 12.2% from 2016 to 2024 and outperform USD 4 billion by 2024. Outsourcing accomplishes better Pharmacovigilance through administrative undertakings consistence, better quality, upgraded efficiency and enhanced key results. 

With the quick advancing administrative condition and stricter rules in Asia, guarantee that the organization's medication security and hazard administration strategies consent to appropriate laws, controls, and direction. 

Japan, South Korea, Malaysia, Thailand is seeing quick development and is expected to grow at a CAGR of more than 13% amid the estimate time frame because of substantial talented workforce and steady test to orchestrate Pharmacovigilance framework in creating economies. 

Japan is the world's second biggest pharmaceutical market, with yearly offers of roughly 6.45 trillion Yen (US $64.5 billion), after the USA. The Japanese pharmaceutical market creates 67% of the Asia-Pacific market and brags of a sound PV framework set up. 

Japan is seeing fast development and is expected to extend at a CAGR of more than 13% amid the conjecture time frame because of expansive gifted workforce and steady test to orchestrate Pharmacovigilance framework in creating economies 

Korea, one of the principle techniques for observing the Drug security of showcased drugs is unconstrained detailing arrangement of suspected ADRs. Reconsideration and re-assessment framework are in constrained for observing the wellbeing of new market endorsement drugs and for those medications presently under showcasing. Provincial PV focuses are assigned from Korean Food and Drug Administration (KFDA) for encouraging ADR observation. Over late years, with the improvement of data innovation, there has been an expanded enthusiasm for building up information digging framework for recognizing signals from Health Insurance Review Agency database. Pharmacovigilance Market Expected to Reach USD 6.10 Billion of every 2020 

China Pharmacovigilance is the national market with the best volume of wellbeing information prepared every year. In some ways this isn't amazing, given how crowded the nation is. Then again, the whole Pharmacovigilance program began fifteen years back in 1989, so there has been tremendous advancing in getting the program to this stage so quickly. Vision pick up trusts this is just the begin of a mainstream increment in the requests of medication security checking in China. In 2013, Pharmacovigilance spending in China was $0.34bn; by 2018 this figure will have ascended to $0.66. Pharmacovigilance spending will increment at a CAGR of 14.0% for the initial five years of the gauge. In the vicinity of 2018 and 2024 spending will keep on growing, at a minimal lessened CAGR of 12.5% 

Development in spending will be driven by a general increment in volume of ADRs detailed and recorded in China throughout the following ten years. This information will require corresponding increment in staffing levels at all purposes of the pharmaceutical store network. Controllers will likewise need to expand their staffing levels to adapt to the expanded workload for observing medication wellbeing. Vision gain suspects an expanded interest for analysts and informatics frameworks to quickly distinguish developing medication wellbeing signals. By 2024, spending on Pharmacovigilance operations in China will have come to $1.34bn every year, an expansion of 294% through the span of ten years. The Chinese Pharmacovigilance market will be the second biggest national market in 2024, having obscured Germany amid 2020. 

Brazil Pharmacovigilance piece of the pie was over 60% of local income for 2015, with target slated to surpass USD 300 million by 2024. South Africa Pharmacovigilance advertise estimate was more than USD 37 million and expected for more than 5% development. 

UAE Pharmacovigilance advertise is required to achieve a market size of $8.23 billion by 2022.

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