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Theme: Exploring Latest Trends in Pharmacovigilance and Clinical Trials in the era of COVID-19

pharmacovigilance 2022

Scientific Program 2022

Renowned Speakers

Mayada Alkhakany
Senior Global NTA Manager, Boehringer Ingelheim
Germany

Eliana Silva de Moraes
President Brazilian Regulatory Affairs
France

Antonio Steardo
pharmaceutical and professional consultant,
Italy

KHAUDEJA BANO
EXECUTIVE MEDICAL DIRECTOR, COMBINATION PRODUCT SAFETY HEAD GLOBAL PATIENT SAFETY & PEDIATRICS AMGEN,
USA

Robert Massouh
Director - Risk Management Product Lead at Pfizer,
UK

Dr. Ilke Sipahi
Department of Cardiology, Acibadem University Medical School, Istanbul,
Turkey

MINHONG CHOA
Yonsei University
South Korea

Manal Younus
Head of Iraqi Pharmacovigilance Center, MOH. ISoP Advisory Board Member, CIOMS Executive Board Member, ISoP Middle East Chapter Vice President
Iraq

Aaron Damien Barzey
Associate Director, Scientific Support Galapagos
UK

Rimma Battalova
QPPV Arterium Corporation Kyiv
Ukraine

Joan Dâ€™souza
Regulatory Medical Writer/ Pharmacovigilance/Juris Doctor/ ISoP Chair for Switzerland and Austria/ EMWA volunteer
Switzerland

Loreta Adomonyte
Pharmacovigilance Manager, EduPharma,
Lithuania

pharmacovigilance 2022

Conference Series is organizing splendorous Pharmaceutical conferences welcomes you to attend the 15^th International Conference and Exhibition on Pharmacovigilance & Drug Safety to be held during September 26-27, 2022, Webinar. It focuses on the advancements in Pharmacovigilance, Risk Management, and Drug Safety.

The field of Pharmacovigilance is growing rapidly and its development is making tremendous impacts in medical sciences and pharmaceuticals. 15^th International Conference and Exhibition on Pharmacovigilance & Drug Safety emphasizes on how the importance and significance can be gauged by the fact that it has made huge advancements over the course of time and is continuing to influence various sectors.

Why to attend???

With members from around the world focused on learning about Pharmacovigilance and its advances; this is your best opportunity to reach the largest assemblage of participants from the Pharmacovigilance community. Conduct presentations, distribute information, meet with current and potential scientists, make a splash with new drug developments, and receive named recognition at this 2-days event. World-Renowned Speakers, the most recent techniques, developments, and the newest updates in Pharmacovigilance are Hallmarks of this Conference.

Target Audience:

Pharmacovigilance Students, Scientists
Pharmacovigilance Researchers
Pharmacovigilance Faculty
Medical Colleges
Pharmacovigilance Associations and Societies
Business Entrepreneurs
Training Institutes
Software Developing Companies
Manufacturing Medical Devices Companies
Data Management Companies

Young Scientist Benefits

Our conferences provide best Platform for your research through oral presentations.
Share the ideas with both eminent researchers and mentors.
Young Scientist Award reorganization certificate and memento to the winners
Young Scientists will get appropriate and timely information by this Forum.
Platform for collaboration among young researchers for better development
Award should motivate participants to strive to realize their full potential which could in turn be beneficial to the field as whole.

Deadline for Registrations:

Platform for collaboration among young researchers for better development
Till March 30, 2022 – $399
Till June 30, 2022 – $499
Till August 27, 2022 – $599

Track 1: Pre-Clinical and Clinical Trials

Clinical trials allow the drug to be tested for safety by different ethnic population. Due to the higher medical needs and increasing disease prevalence, developing countries are becoming a hub for clinical trial execution. The clinical trials market has been estimated to reach USD 14.2 billion in 2019 and is projected to reach around USD 22 billion by the year 2022, and the annual growth rate of (7.5%). There are additionally numerous clinical trials started by scholarly clinical scientists. Whether started by industry or by scholastic clinical examiners and research is frequently performed in national, European and overall consortia, which can be expansive ones. Clinical research brings up moral and security issues. Clinical research is exceedingly controlled. To encourage and coordinated efforts crosswise over fringes.

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Related Associations or Societies:

Societies in USA: International Society of Pharmacovigilance | Drug Safety & Pharmacovigilance | Association of Clinical Research Professionals (ACRP) | American Association of Pharmaceutical Scientists | Association of British Pharmaceutical Industry | the Society of Clinical Research Associates (SOCRA) | Society for Clinical Trials (SCT) | Canadian Association of Professionals in Regulatory Affairs | Clinical Research Society (CRS)

Societies in Europe: European Association for Clinical Pharmacology (EACPT) | International Society of Pharmacovigilance (ISOP) | European Medicines Agency, Pharmaceutical Information and Pharmacovigilance Association (PIPA) | Association of CROs Czech Republic (ACRO-CZ) | European Clinical Research Infrastructures Network (ECRIN) | European Society for Clinical Investigation (ESCI).

Societies in Asia and Pacific: Society of Pharmacovigilance, International Society of Pharmacovigilance: (ISOP) | Indian Society for Clinical Organization Research (ISCR) | Indian Society for Clinical Research | Clinical Trials Society | Society for Clinical Trials Association of Clinical Research | The Society of Clinical Research Associates | Association of Clinical Research Organization | Clinical Research Society | Indian Council of Medical Research (ICMR) | Japan CRO Association (JCROA) | Pan-Asian Clinical Research Association (PACRA) | Central Society for Clinical and Translational Research (CSCTR)

Track 2: Adverse Drug Reactions

Adverse drug reactions can be considered a form of toxicity or enhanced drug effects that occur during appropriate use (eg, when drug metabolism is temporarily inhibited by a disorder or another drug). In the US, 3 to 7% of all hospitalizations are due to adverse drug reactions. ADRs occur during 10 to 20% of hospitalizations; about 10 to 20% of these ADRs are severe. Incidence of death due to ADRs is unknown; suggested rates of 0.5 to 0.9% may be falsely high because many of the patients included had serious and complex disorders. Incidence and severity of adverse drug reactions vary by patient characteristics (eg, age, sex, ethnicity, coexisting disorders, genetic or geographic factors) and by drug factors (eg, type of drug, administration route, treatment duration, dosage, and bioavailability). Incidence is higher with advanced age and polypharmacy.

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Track 3: Pharmacovigilance and Risk Management

Pharmacovigilance and Risk Management comprises set of pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to medicinal and therapeutic products including the assessment of the effectiveness of their clinical interventions and combination therapies. Drug industry need to promote companies in pharmacovigilance practice to use information technology and to review softwares used in pharmacovigilance and clinical trials. Monitoring unlicensed, off labels and orphan drugs is major task in risk management. Many experts from different pharmacovigilance CRO's , pharmacovigilance service providers and industrial delegates are participating in this conference to share their knowledge and discuss about the new updates.

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Track 4: Good Pharmacovigilance Practice

The role of Good Pharmacovigilance Practice and Pharmacoepidemiology in Risk Management is mainly to increase the probability of beneficial effects of a drug in a population than the probability of adverse effects and to maintain the Good Reporting Practices by avoiding the major problems in risk management. Also it is important to concentrate on Signal investigation by gathering the information on new or unknown drug effects that is potentially caused by a medicine and that finally should lead to ensuring safety. The pharmacovigilance and clinical trials services providing companies should have the Pharmacovigilance certification.

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Track 5: Pharmacy Practices and its Challenges

Pharmacy practice is the field of pharmacy which involves developing the professional roles of pharmacists. It includes Disease-state management, Clinical drug interventions, Pharmacy professional development and pharmaceutical care, pharmaceutical compounding and health psychology, patient care, drug abuse prevention, prevention of drug interactions or minimisation of adverse events and drug incompatibility and community pharmacy.

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Track 6: Biopharmaceutical Sciences

In Clinical Pharmacology and Biopharmaceutics track we will discuss about the Rational drug management of cancer, diabetes and cardiovascular disorders, and Management of psychiatric disorders and autoimmune disorders. Along with clinical trials Bioavailability and bioequivalence studies also plays major role in clinical research. The global market for Bio pharmaceutics in 2013 was $305.1 million, which is expected to reach about $326.3 million by year-end 2014. The projected PAT instrumentation market is expected to be valued at around $450.6 million by 2019 at a compound annual growth rate (CAGR) of 6.7% for the period of 2014 to 2019.

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Track 7: Clinical Trials on Various Disorders

Clinical Trials on various diseases include Clinical Trials in long chronic diseases like AIDS, Benign and Malignant Tumours, Cardiovascular diseases, Diabetes, Clinical Trials on Monoclonal and Polyclonal Antibodies, Neurological, Physiological and Psychological Disorders

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Track 8: Data Quality Management and Analysis

Good data quality management in pharmacovigilance can be relied only on information gathered from the collection of individual case safety reports and other pharmacoepidemiological data. Quality management consists of quality planning, quality control, quality assurance and quality improvements. The pharmacovigilance data processing cycle starts with data collection and, in computerised systems, data entry; the next step is data storage and maintenance; followed by data selection, retrieval and manipulation. The resulting data output is analysed and assessed. Finally, conclusions are drawn and decisions are made. The quality of a pharmacovigilance data system can be defined as a measure of excellence or a state of being free from defects, deficiencies and significant variations and the data quality management includes all the activities that organizations use to direct, control and coordinate the quality of data.

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Track 9: Pharmacovigilance Significance & Scope

Concept of Pharmacovigilance and its Significance enhances the impact of pharmacovigilance on patient welfare and public health and to know what is pharmacovigilance. This track gives a brief discussion on Pharmacovigilance role in healthcare system. Pharmacovigilance legislation gives an outlook on the rules and laws to follow in Pharmacovigilance practice. The Role of Pharma industries in the improvement of pharmacovigilance system is very crucial to maintain the safety data, Detection and Evaluation of drug safety signals through manual and medical devices reporting. Pharmacovigilance scope also deals as Ecopharmacovigilance (EPV), pharmacoenvironmentology and pharmacovigilance in herbal medicines.

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Track 10: Diversity in Industrial Clinical Trials and Clinical Research

The clinical trial industry is constantly evolving with diversified clinical research technologies and new clinical studies are being launched at an ever-growing pace. Clinical trials have always been a vital part of the medicine development process, as they provide clinical data on the best ways for treating pathological disorders and diseases. The importance of diversity in industrial clinical trials and clinical research is to ensure that industrial clinical trials are doing due diligence and being as strategic as possible in their results. This diversity makes us to better understand the unmet medical needs of patients.

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Track 11: Clinical Research and Statistics

In Clinical Research, Statistics plays a prominent role in regulatory submissions. Statistical analysis of Pharmacovigilance can be achieved by several guidelines mainly ICH guidelines. Adverse Drug Reactions reports can also be considered for the regulatory submission.

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Track 12: Case Report in Clinical Trials

Case Report in Clinical Trials plays a key role in Clinical Research. Case reports may be on unexpected association between diseases, disorders or symptoms. An unexpected event in the course of observing, treating a patient, possibilities of pathogenesis of a disease or an adverse effect. Unique or rare salient features of a disease or therapeutic approaches or a notable variation of the anatomical structures.

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Track 13: Drug Safety

Drug Safety heavily focuses on adverse drug reactions which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. 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.

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. Ultimately, drug safety 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.

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Track 14: Clinical Data Base Management

There is an advantage in centralising all safety data, clinical data, analysis and reporting with one provider. Pharmacovigilance Software tool provides comprehensive analysis of adverse events arising from the use of Pharmaceutical products (Medicinal Product, Medical Device, Vaccines, Non-Drug Therapy and Veterinary Medicinal Product). The drug safety database allows the risk- benefit analysis of medicinal products taking into account new and emerging information, in the context of cumulative information. Pharmacovigilance since beginning has been a compliance driven activity, wherein your regulatory compliance determines company’s risk assessment scores. A drug safety database offers scheduling of alerts for expedited cases, follow-up cases and PSUR/PADER reports submission to meet regulatory timeline compliance.

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Track 15: PV Consulting’s and Business opportunity

Due to the changing resources necessary to fulfil the regulatory requirements, some companies also choose to outsource or out task regulatory affairs to external service providers. Regulatory Affairs department is constantly evolving and growing and is the one which is least impacted during the Acquisition and Merger, and also during recession. The global pharmacovigilance market and Business opportunity was valued at USD 2,408.0 million in 2013 and is expected to grow at a CAGR of 12.6% during the forecast period. Phase III clinical trials market was the second largest and was valued at over USD 750.0 million in 2013.

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Track 16: Regulatory Affairs

Regulatory Affairs for clinical trials is the major part in the clinical trials approaches. Every clinical trial must be analysed according to the Regulatory Affairs Guidelines. There are several Regulatory Affairs departments depending upon the countries within ever growing pace of companies. Global Harmonization in standards has led to consistent approach in regulatory submissions and hence its review.

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Track 17: Entrepreneurs Investment Meet

Initial investment, capital requirements, business financing, current trends and the amount of time will take to get your business up and running. Pharmacovigilance 2017 focus in collaboration and communication among the Pharma Professionals, Business Entrepreneurs, CEO’s and Pharma Industrial Persons.

Pharmacovigilance Journals

Top Pharmaceutical Universities around the world:

Europe Pharmacovigilance Universities:

Pharmacovigilance Companies :

Europe Pharmcovigilance Conpanys Europe:

Pharmacovigilance Jobs:

Pharmacovigilance Associate – Unicon Labs | Global Drug Safety Risk Management Lead | Senior Drug Safety Assisstant - Katalyst Healthcares & Life Sciences | Drug Safety Associate Bioclinica | Senior Manager, Clinical Drug Safety Pacira Pharmaceuticals | Senior Drug Safety Associate Covance | Manager, Drug Safety & Pharmacovigilance Avanir Pharmaceuticals | Director, Drug Safety Miragen Therapeutics | Global Regulatory Affairs-GI Takeda Pharmaceutical, Manager | Compliance Monitoring and Risk Management Shire Pharmaceuticals | Risk Management Plan Manager in Novartis | | Junior Research Fellow in South India Textile Research Association | Formulations R&D in Celon Laboratories Ltd | Associate Global Trial Director in Novartis.

Pharmacovigilance 2022 welcomes attendees, presenters, and exhibitors from all over the world to Paris, France. We are delighted to invite you all to attend and register for the “15^th International Conference and Exhibition on Pharmacovigilance & Drug Safety” which is going to be held during September 26-27, 2022, Webinar. The Organizing Committee is gearing up for an exciting and informative conference program including plenary lectures, symposia, workshops on a variety of topics, poster presentations and various programs for participants from all over the world. We invite you to join us at the Pharmacovigilance 2022, where you will be sure to have a meaningful experience with scholars from around the world. All the members of Pharmacovigilance 2022 Organizing Committee will look forward to meet you at Online conference.

Importance and Scope: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The main purpose of Pharmacovigilance is to improve the patient's safety and enhance his care in terms of the use of medicines, including paramedical interventions. Pharmacovigilance also supports public health programs by providing reliable information for the efficient assessment of the risk-benefit profile of medicines, contribute to the assessment of benefits, uses, side effects, harm, effectiveness and risk of medicines, encouraging the safe, rational and more effective (including cost-effective) use of various medicines. Promote education, understanding and clinical training in Pharmacovigilance and its effective availability to the public

The Global Pharmacovigilance Market is expected to reach USD 5.51 billion by 2021. Increasing incidence rates of adverse drug reaction (ADR) 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.

Pharmacovigilance Market, by Phases of Drug Development:

Preclinical Studies
Phase I
Phase II
Phase III
Phase IV or Post Marketing Surveillance

Pharmacovigilance Market, by Type of Methods:

Spontaneous Reporting
Intensified ADR Reporting
Targeted Spontaneous Reporting
Cohort Event Monitoring
EHR Mining

Pharmacovigilance Market, by Type of Service:

In-House
Contract Outsourcing

Conference Highlights

Drug Safety
Adverse Drug Reactions
Pharmacovigilance Significance & Scope
Good Pharmacovigilance Practice
Pharmacovigilance and Risk Management
Pharmacokinetics and Pharmacodynamics
Pre-Clinical and Clinical Trials
Clinical Trials on Various Disorders
Diversity in Industrial Clinical Trials and Clinical Research
Clinical Research and Statistics
Case Report in Clinical Trial
Data Quality Management and Analysis
PV Data Base Managemaent
PV Consultings And Bussiness Opportunity
Regulatory Affairs
Growth Strategies in Pharma
Pharmacy Practices and its Challenges
Entrepreneurs Investment Meet

Global pharmacovigilance market, by clinical trials, 2012 – 2021 (USD Million)

Pharmacovigilance 2021

We gratefully thank all our wonderful Speakers, Conference Attendees, Students, Media Partners, Associations and Exhibitors for making Pharmacovigilance 2022 Conference the best ever!

The 14th International Conference and Exhibition on Pharmacovigilance & Drug Safety, hosted by the Conference Series llc LTD was held during September 15-16, 2022 as Webinar based on the theme “Exploring Latest Trends in Pharmacovigilance and Clinical Trials in the era of COVID-19". Benevolent response and active participation were received from the Organizing Committee Members along with Scientists, Researchers, Students and leaders from various fields of Pharmaceutics and Drug Delivery Systems, who made this event a grand success.

Conference Series expresses its gratitude to the conference Moderator, namely Patricia , Pharmacovigilance Program Coordinator.

The conference was initiated with the Honourable presence of the Keynote forum. The list includes:

Dr. Robert Weber, Oracle Health Sciences, Germany

Dr. Chaitanya N. Hiremath, Founder, President & CEO of APODvision, Inc., Massachusetts, USA

Dr. Kai Heib, CEO of INTLAB , Switzerland

Dr. Massoud Toussi, IQVIA, Paris, France

Dr. Lingli Zhang, West China Second University Hospital, Sichuan University, China

Karl-Dietrich Hatz, CMOO of INTLAB, Switzerland

Dr. TURKI ALOZAYB, Pharm D, ALMAAREFA UNIVERSITY, Saudi Arabia

Francesca Rollo, Viatris company , Italy

And delegates and students more…

The meeting reflected various sessions, in which discussions were held on the following major scientific tracks:

Pre-Clinical and Clinical Trials

Adverse Drug Reactions

Pharmacovigilance and Risk Management

Good Pharmacovigilance Practice

Pharmacy Practices and its Challenges

Biopharmaceutical Sciences

Clinical Trials on Various Disorders

Pharmaceutical Excipients

Drug Design and Development

Pharmaceutical Analysis

Drug Product Manufacturing

Smart Drug Delivery Systems

Regulatory Affairs

Entrepreneurs Investment Meet

Conference Series Group offers it’s heartfelt our esteemed Media Partners:

Conference Locate.com; THE PHARMA WORLD; The British Society of Toxicological Pathology (BSTP); Crowd Reviews; Tabeeby; CourseForDoctors.com; and Atlas of Science

Also other eminent personalities who supported the conference by facilitating the discussion forums. Conference Series also took privilege to felicitate the Keynote Speakers, Organizing Committee Members, Chairs and Exhibitors who supported this event.

With the grand success of Pharmacovigilance 2021, Conference Series is proud to announce the 15th International Conference and Exhibition on Pharmacovigilance & Drug Safety " to be held during September 26-27, 2022, Webinar.

For More details visit: https://pharmacovigilance.pharmaceuticalconferences.com/

Conference Highlights

To share your views and research, please click here to register for the Conference.

To Collaborate Scientific Professionals around the World

Conference Date	September 26-27, 2022
Sponsors & Exhibitors	~~Click here for Sponsorship Opportunities~~
Speaker Opportunity Closed	Day 1
Poster Opportunity Closed	Click Here to View