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Euro Pharmacovigilance 2022

About conference

We warmly welcome all the participants to attend our event Euro Pharmacovigilance Meet 2022 entitled “3rd European Conference on Pharmacovigilance and Drug Safety” webinar scheduled on June 07-08, 2022,Webinar. Across the theme “COVID-19 Challenges for Pharmacovigilance and Drug Safety “

This conference provides a forum for interaction among attendees with discussion involving discovery of a new drug, Challenges in drug development. Which includes a large range of prompt Keynote presentations, Poster presentations, Oral presentation, Exhibitions, Symposiums & Workshops? It's a right platform for researchers, scientists and delegates to share their expertise, poster collaborations across business and domain, and valuate rising technologies across the globe.

Euro Pharmacovigilance 2022 Meet your target audience with members from around the world focused on learning about Pharmacovigilance and Drug Safety , this is your single best opportunity to reach the largest assemblage of participants from the Pharma and medicinal community, Find out how innovators are closing the gap between product development and adoption, Better identify cyber threats and reduce information security risks, Debate the potential to greater cross-industry and cross-sector collaboration in the race for faster, cheaper, better cures. Conduct demonstrations, distribute information, meet with current and potential Scientists, make a splash with a new research, and receive name recognition at this event Euro Pharmacovigilance 2022. World-renowned speakers, the most recent techniques, tactics, and the newest updates in Pharmaceutical Sciences fields 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

sessions / tracks

Track 1: Pharmacovigilance

Pharmacovigilance defined as the study of activities which relate to the detection, assessment, understanding and prevention of adverse effects. Pharmacovigilance is public health function and study of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines and also a key to drug safety. PV analysis evaluated in Phase I, Phase II, and Phase III a clinical trial which provides drug companies data on the safety assurance of the drug. The aim of pharmacovigilance in industrial areas are essentially the same as those of regulatory agencies; which is to protect patients from unnecessary harm by identifying previously unrecognised drug hazards, refuting false safety signals and quantifying risk to benefit.

Track 2: Impacts of PV on Covid-19

The current challenges posed by the COVID-19 pandemic have also prompted regulatory agencies to reconsider their requirements and have emphasised the importance of electronic reporting to ensure data exchange for patient safety. A strong process for regulatory intelligence maintenance, a rapid change-implementation process and robust system to enter rule-based decisions can contribute to ensure compliance and quality.

Track 3: Good Pharmacovigilance Practices

Good pharmacovigilance practices are measures drawn up to facilitate the performance of pharmacovigilance in the European Union. Application of GVP to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities. They include medicines authorised centrally via the Agency as well as medicines authorised at higher level. Pharmacovigilance system defined as the system used by an organisation to fulfil its legal tasks and responsibilities in relation to pharmacovigilance and designed to monitor the safety of authorised medicinal products and detect change to their risk-benefit balance.

Clinical trial safety

Post-marketing safety

Regulatory submissions for safety

Track 4: Pharmacovigilance risk management plans

Risk management plan explains the knowledge about the safety and efficacy of a medicinal product. The RMP gives information on plans for studies and other activities to gain knowledge on the safety and efficacy of the medicine. It also describes measures to be undertaken to minimise risks associated with the use of product in patients. Marketing authorisation holders are required to have an RMP for any new medicinal product for human use that must be submitted at the time of application for marketing authorisation. For nationally authorised products RMPs must be submitted for review and approval.

Track 5: Pharmacokinetics and pharmacodynamics

Study of what the body does to the drug is known to be Pharmacokinetics, and Pharmacodynamics is the study of what the drug does to the body. Pharmacokinetics refers to the movement of any drug going into, Through, and out of the body. Pharmacodynamics means is to think of the word ‘dynamo’. Dynamo typically refers to energy or power. In terms of pharmacodynamics, it includes how the drug works and how it exerts its power on the body. Where as in pharmaceuticals, pharmacodynamics focuses on receptor binding and chemical interactions.The bio therapeutic is dosed and samples are collected to determine the pharmacokinetic properties of the drug.

Drug-receptor interaction

Complex chemical interactions

Drug Administration

Track 6: Pharmacovigilance Operations

The PV Operations include Case Management, Alliance and Vendor Management, and Quality and Document Management. Individual have to manage the operation infrastructure required to oversee all aspects of adverse event collection, processing, and reporting from clinical trials. Responsible for development and preparation of the safety sections of protocols, investigator brochures, clinical study reports, and other documents to ensure that the documents are appropriate, feasible, operational and accurately reflect the safety and/or risk-benefit profile.

Pharmacovigilance outsourcing

Standard operating procedures

Post-marketing case processing

Track 7: Drug Safety

Medication Safety is not new in the developed countries in the field of health. All drugs have side effects, but the extent of their impact and severity varies from mild to severe. Side effects are predictable and mentioned in the leaflets for each drug. Some of the drugs side effects are have not been noticed, and the real risk here is whether they would exert a severe deleterious impact on the patients who are using them. Few drugs may not cause adverse symptoms, such as some types of antibiotics; other medications may cause serious symptoms, such as certain cancer drugs, anti-diabetic medications, medications to control elevated blood lipids, and many others.

Methodology

Frequency of adverse drug effects

Drug Safety toxicology

Track 8: PV Inspection and Audit Readiness

To determine that the marketing authorisation holder has personnel, systems and facilities in place to meet their pharmacovigilance obligations, to identify, record and address non-compliance which may pose a risk to public health, to use the inspection results as a basis for enforcement action, where considered necessary. The aim of a pharmacovigilance audit is to use objective evidence to assess the appropriateness and effectiveness of the implementation and operation of a pharmacovigilance system. The audit must be clearly documented and can only rely on verifiable evidence, such as written records and statements.

Track 9: Patient Support Programs

The evolution of technology has increased the access to and potential value of these programs. Many Patient Support Programs include disease information and resources, value-add tools and services, access to nurses or other healthcare professionals via phone or online chat, financial assistance, co-pay or savings programs devices such as blood glucose monitors, wireless health trackers, etc.

Track 10:  Market Research Programs

Medical Affairs, Market Research and Marketing must be sensible about the risks, obligations and PV costs results in such initiatives. Few companies charge back for PV activities, which makes sense as it should be in actual cost of running a survey or disease registry. It is very critical that PV involved at the earliest stages of the Patient Support Programs/Market Research Programs design and approval. This is a way to ensure that the safety data information from the initiatives will be collected and analyzed, and contributed to the signal detection activities, and will be reported to the authorities as needed. The cost for non-compliance is potentially very high.

Safety Monitoring and Reporting

Pharmacovigilance operations

Quality Assurance

Track 11: Artificial Intelligence in Signal Detection

An information that suggests a potential causal association between an intervention and an event, indicating the possibility of unintended outcomes. A signal might uncover rare but dangerous side effect in a marketed drug did not emerge in clinical trials. Generally, signal detection was a reactive process. If an adverse event, such as a heart attack,was reported by a patient or their physician, related to a specific treatment, the report would be studied and actions taken if the signal proved reliable and meaningful to the context of the treatment.    

Proactive signal detection

Passive Wi-Fi sensing system

Artificial Intelligence Detection

Track 12: Drug Development

The process of bringing a new drug molecule into clinical practice is explained as Drug Development. This encompasses all steps from the basic research process to support the commercial launch of the drug. Development refers to the clinical parts of this process, with discovery which is used to explain the nonclinical research components. Researchers identify a promising compound for development, they gather information to conduct experiments on how it is absorbed, distributed, metabolized, and excreted, its potential benefits and mechanisms of action and the best dosage.

Preclinical Studies

Valuation

Modern Drug Development

Track 13: Pharmaceutical Toxicology

Pharmaceutical toxicology lies on the margin of the toxicology and drug discovery, and includes all the research about harmful effects and safety of medicines in relation to the therapeutic benefits. In adding and determination of the direct effect of the potential drug on the functioning of cells,Tissues and organisms. Toxicologists can use computer models and in vivo tests to understand whether metabolism body is likely to affect the toxicity of the drug.

Safety assessment of pharmaceuticals

Safety Sciences of Drugs

Immunotoxicity

Biomedical Analysis

Track 14: Drug Tolerance

Drug tolerance is revealing of drug use but is not necessarily associated with drug dependence or addiction. The process of tolerance development is reversible that can involve both physiological factors and psychological factors. Drug tolerance should not be disordered with drug tolerability, which refers to the grade to which over adverse effects of a drug can be tolerated by a patient.

Behavioral tolerance

Pharmacodynamic tolerance

Drug tolerance mechanism

Track 15: Regulatory Efforts

Regulatory affairs experts play a significant role in communication between their company and different regulatory bodies such as the FDA, Singapore HSA, etc. We provide a wide range of regulatory affairs services, including assessing and repayment, to our client. 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.

Food, drug and cosmetic laws

Regulatory Authorities

Generic drug submissions

Regulatory Guidelines

Track 16: Adverse drug reactions

Adverse drug reactions can be considered a form of toxicity .toxicity is most commonly applied to effects of over absorption. For information on toxicity of specific drugs see the table Symptoms and Treatment of Specific Toxins. Adverse drug reactions are usually classified as mild, moderate, lethal (see table Classification of Adverse Drug Reactions [ADRs]. Severe or lethal ADRs may be specifically mentioned in black box notices in the physician prescribing information provided by the manufacturer.

Life-threatening

Assessing and reporting adverse drug reactions

Classification of various adverse drug reactions

Track 17: Bio-Pharmaceutics

Bio Pharmaceutics conferences plays an important role in drug discovery like drug disposition, Innovations in clinical development, Pharmaceutical technology, Pharmaceutics and drug delivery, Drug design, Targeted drug, gene deliverySustained drug delivery system, Routes of administration, Fundamental drug development.

For more information visit: Pharmaceutical Conferences

Related Conferences:

12th European Chemistry Congress June 06-07, 2022 Rome, Italy; 32nd Annual European Pharma Congress April 25-26, 2022 Barcelona, Spain; 11th International Conference on Cosmetology & Beauty February 07-08, 2022 London, UK; 23rd International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems February 21-22, 2022 Berlin, Germany; 9th World Congress and Exhibition on Antibiotics and Antibiotic Resistance March 07-08, 2022 Barcelona, Spain; 23rd Euro-Global Summit on Toxicology and Applied Pharmacology March 09-10, 2022 Barcelona, Spain; 23rd International Conference on Industrial Chemistry and Aqua Technology May 16-17, 2022 London, UK; 20th International Conference and Exhibition on Materials Science and Chemistry March 21-22, 2022 Rome, Italy.

Related Societies:

Bio Pharma Societies in USA:   International Biopharmaceutical Association, Consumer Healthcare Products Association (CHPA), Generic Pharmaceutical Association (GPhA), International Pharmaceutical Expedient Council, Pharmaceutical Research and Manufacturers of America (PhRMA) Synthetic Organic Chemical Manufacturers Association (SOCMA), Biotech Industry Association (BIO), Parenteral Drug Association (PDA), Chinese Biopharmaceutical Association, Pharma & Biopharma Outsourcing Association (PBOA), SAFE-BioPharma Association and The BioPharmaceutical Emerging Best Practices Association (BEBPA)

Bio Pharma Societies in EuropeEuropean Federation of Pharmaceutical Industries and Associations (EFPIA), European Biopharmaceutical Enterprises (EBE), European Association of Pharma Biotechnology, International Federation of Pharmaceutical Manufacturers & Associations, European Federation of Biotechnology, EuropaBio and European and Developing Countries Clinical Trials Partnership

Bio Pharma Societies in Asia:  The Hong Kong Association of the Pharmaceutical Industry, International Pharmaceutical Manufacturers Group, International Research-based Pharmaceutical Manufacturers Association, Japan Pharmaceutical Manufacturers Association, Korea Pharmaceutical and Bio-Pharma Manufacturers Association, Korean Research-based Pharmaceutical Industry Association, Organization of Pharmaceutical Producers of India, Pharmaceutical Association of Malaysia, Pharmaceutical and Healthcare Association of the Philippines, China Pharmaceutical Innovation & Research Development Association, Pharmaceutical Research & Manufacturers Association, R&D-based Pharmaceutical Association Committee, Singapore Association of Pharmaceutical Industries

Bio Pharmaceutics Journals: European Journal of Pharmaceutics and Biopharmaceutics, International Journal of Biopharmaceutics, Journal of Biopharmaceutics and Biotechnology, Biopharmaceutics and Drug Disposition, Journal of Pharmacokinetics and Biopharmaceutics, Journal of Biopharmaceutical Statistics, Journal of Biopharmaceutics and Therapeutic Challenges, Journal of applied biopharmaceutics and pharmacokinetics, Journal of Applied Biopharmaceutics and Pharmacokinetics, Statistics in Biopharmaceutical Research, EBR - European Biopharmaceutical Review, Russian Journal of Biopharmaceuticals

Track 18: Drug Targeting and Design

Drug Design, often referred to as rational drug design or simply rational design, is the inventive process of finding new medications based on the knowledge of a biological target. The drug is most commonly an organic small molecule that activates or inhibits the function of a biomolecule such as a protein, which in turn results in a therapeutic benefit to the patient. In the most basic sense, drug design involves the design of molecules that are complementary in shape and charge to the biomolecular target with which they interact and therefore will bind to it. Drug design frequently but not necessarily relies on computer modeling techniques. This type of modeling is sometimes referred to as computer-aided drug design. Finally, drug design that relies on the knowledge of the three-dimensional structure of the biomolecular target is known as structure-based drug design. In addition to small molecules, biopharmaceuticals and especially therapeutic antibodies are an increasingly important class of drugs and computational methods for improving the affinity, selectivity, and stability of this protein-based therapeutics have also been developed

For more information visit: Pharmaceutical Conferences

Related Conferences:

12th European Chemistry Congress June 06-07, 2022 Rome, Italy; 32nd Annual European Pharma Congress April 25-26, 2022 Barcelona, Spain; 11th International Conference on Cosmetology & Beauty February 07-08, 2022 London, UK; 23rd International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems February 21-22, 2022 Berlin, Germany; 9th World Congress and Exhibition on Antibiotics and Antibiotic Resistance March 07-08, 2022 Barcelona, Spain; 23rd Euro-Global Summit on Toxicology and Applied Pharmacology March 09-10, 2022 Barcelona, Spain; 23rd International Conference on Industrial Chemistry and Aqua Technology May 16-17, 2022 London, UK; 20th International Conference and Exhibition on Materials Science and Chemistry March 21-22, 2022 Rome, Italy.

Related Societies:

Drug Discovery Societies in USAAmerican Association of Pharmaceutical Scientists (AAPS), American Peptide Society (APS), American Society for Biochemistry and Molecular Biology (ASBMB), American Society for Pharmacology and Experimental Therapeutics (ASPET), Biophysical Society, American Association for Clinical Chemistry (AACC), American Crystallographic Association (ACA), American Institute of Chemical Engineers (AIChE)

Drug Discovery Societies in EuropeRoyal Society of Biology, Association of the British Pharmaceutical Industry (ABPI), The BioIndustry Association, British Pharmacological Society (BPS), Biochemical Society, The Physiological Society, International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), European Photochemistry Association, European Federation for Medicinal Chemistry (EFMC), European Federation for Pharmaceutical Sciences (EUFEPS), European Federation for the Science and Technology of Lipids (EuroFedLipid), Euroscience and International Pharmaceutical Federation

Drug Discovery Societies in Asia and PacificChemical Society of Thailand, Singapore National Institute of Chemistry, Serbian Chemical Society (SCS), Integrated Chemists of the Philippines, New Zealand Institute of Chemistry, Malaysian Institute of Chemistry, Association of Latvian Chemical and Pharmaceutical Industry (LAKIFA), Kuwait Chemical Society

Drug Discovery Journals: American Journal of Drug Discovery and Development, Nature Reviews Drug Discovery, Drug Discovery Today, Expert Opinion on Drug Discovery, Current Pharmaceutical Design, Current Drug Discovery Technologies, International Journal of Drug Discovery, Drug Metabolism and Pharmacokinetics, International Journal of Drug Development and Research (IJDDR) and Drug Development Research, Journal of Computer-Aided Molecular

Design, Drug Design, Development and Therapy, Journal of Drug Discovery, Development and Delivery, The Open Drug Discovery Journal and Drug Development and Industrial Pharmacy

Track 19: Pharmacokinetics and Pharmacodynamics in Drugs

Pharmacokinetics is currently defined as the study of the time course of drug absorption, distribution, metabolism, and excretion. Clinical pharmacokinetics is the application of pharmacokinetic principles to the safe and effective therapeutic management of drugs in an individual patient. Primary goals of clinical pharmacokinetics include enhancing efficacy and decreasing toxicity of a patient’s drug therapy. The development of strong correlations between drug concentrations and their pharmacologic responses has enabled clinicians to apply pharmacokinetic principles to actual patient situations.

Pharmacodynamics refers to the relationship between drug concentration at the site of action and the resulting effect, including the time course and intensity of therapeutic and adverse effects. The effect of a drug present at the site of action is determined by that drug’s binding with a receptor.

For more information visit: Pharmaceutical Conferences

Related Conferences:

12th European Chemistry Congress June 06-07, 2022 Rome, Italy; 32nd Annual European Pharma Congress April 25-26, 2022 Barcelona, Spain; 11th International Conference on Cosmetology & Beauty February 07-08, 2022 London, UK; 23rd International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems February 21-22, 2022 Berlin, Germany; 9th World Congress and Exhibition on Antibiotics and Antibiotic Resistance March 07-08, 2022 Barcelona, Spain; 23rd Euro-Global Summit on Toxicology and Applied Pharmacology March 09-10, 2022 Barcelona, Spain; 23rd International Conference on Industrial Chemistry and Aqua Technology May 16-17, 2022 London, UK; 20th International Conference and Exhibition on Materials Science and Chemistry March 21-22, 2022 Rome, Italy.

Related Societies:

Pharmacokinetics Societies in USA: AACP (American Association of Colleges in Pharmacy), American Association of Pharmaceutical Scientists-AAPS, American College of Clinical Pharmacy (ACCP), ACPE – Accreditation Council for Pharmacy Education, AMCP (Academy of Managed Care Pharmacy), American Pharmacists Association (APhA), American Society of Consultant Pharmacists -ASCP, ASHP – American Society of Health-System Pharmacists, AZO (Alpha Zeta Omega), BPS (Board of Pharmacy Specialties), CPA – Connecticut Pharmacists Association

Pharmacokinetics Societies in Europe: European Association of Employed Community Pharmacists in Europe (EPhEU), Pharmaceutical Group of the European Union (PGEU), Danish Association of Pharmaconomists, Pharmaceutical Society of Ireland, National Pharmacy Association, Pharmaceutical Society of Northern Ireland and Royal Pharmaceutical Society (RPS), International Pharmaceutical Federation (FIP) and International Pharmaceutical Students' Federation (IPSF)

Pharmacokinetics Societies in Asia and Middle East: Australian College of Pharmacy, Pharmaceutical Society of Australia, The Pharmacy Guild of Australia, The Society of Hospital Pharmacists of Australia, Chinese Pharmaceutical Association, The Pharmaceutical Association of Israel and Kuwait Pharmaceutical Association

Pharmacokinetics & Pharmacodynamics Journals: Drug Metabolism and Pharmacokinetics, Journal of Pharmacokinetics and Pharmacodynamics, Journal of Pharmacokinetics & Experimental Therapeutics, Clinical Pharmacokinetics and International Journal of Pharmacokinetics

Market Analysis

The global Pharmacovigilance (PV) and drug safety software market is expected to reach US$ 262.02 Mn in 2027 from US$ 151.07 Mn in 2018. The Pharmacovigilance (PV) and drug safety software market is estimated to grow with a CAGR of 6.4% from 2019-2027.

The market is driven by factors such as, rising incidences of adverse drug reactions (ADRs) and globalization of Pharmacovigilance. However, expensive technology may limit the growth of the market to a certain extent.

The Pharmacovigilance (PV) and drug safety software are used to recognize the cause of drug withdrawal and helps to inhibit unnecessary future events. These software are beneficial to those involved in drug making process like clinical research organization and pharmaceutical companies. These software help companies to manage huge data generated due to adverse drug reaction events. Help to maintain data for regulatory inspection and approval. These software lets global information to be shared rapidly and economically

The global Pharmacovigilance market size was estimated at USD 4.31 billion in 2018 and is anticipated to witness a CAGR of 13.3% over the forecast period. Increasing incidence of Adverse Drug Reactions (ADRs) is expected to accelerate the demand for Pharmacovigilance (PV) services.

Growing prevalence of chronic diseases is another major contributor for the growth of the market. Treatment of these chronic diseases require uptake of combination of drugs resulting in ADR. PV services are used to curb this problem. According to the statistics published in the Journal of American Medical Association (JAMA), in 2014, ADR was one of the leading causes of mortality in U.S., resulting in more than 100,000 deaths every year.

Global Pharmacovigilance and Drug Safety Software Market: Overview

Increasing approvals for new molecules and biosimilars

New molecules and biosimilars undergo drug safety assessments before their launch in the market. This is to ensure that the drugs comply with safety standards as per regulations. This rise in approval of new molecular entities and biosimilars as well as registered activities of clinical trials globally has resulted in a surge in the adoption of Pharmacovigilance and drug safety software which will subsequently lead to the expansion of the global Pharmacovigilance and drug safety software market at a CAGR of close to 7% during the forecast period.

Outsourcing Pharmacovigilance and drug safety research to CROs

To reduce the operational costs and provide revenue-generating opportunities to the vendors, Pharmacovigilance, and drug safety operations are being outsourced to developing economies such as India, China, and the Philippines. This trend is expected to have a positive impact on the overall market growth.

Past Conference

Conference Series LLC ltd is a renowned organization that organizes highly notable conferences is successfully affixed its “3rd European Conference on Pharmacovigilance and Drug Safety ” (Euro Pharmacovigilance 2022) slated during June 07-08, 2022 at Hotel Agora Moriguchi in Osaka, Japan.

Our “3rd European Conference on Pharmacovigilance and Drug Safety” was based on the theme of “Promulgating the prevention of adverse drug reaction” which has covered the below scientific sessions:

Clinical Research and Statistics

Adverse Drug Reactions

Causality Assessment

Hospital and Industrial Pharmacy

Clinical Trials Pharmacovigilance

Pharmacovigilance Significance & Scope

 Pharmacovigilance Practice

Drug Safety

Clinical Trial Protocols

Diversity in Industrial Clinical Trials and Clinical Research

Clinical Database Management

PV Consulting’s And Business opportunity

Bio pharmaceutics

Regulatory Affairs

Analysis of Data quality and Management

Entrepreneurs Investment Meet

The Conference received acknowledgments & immense support was extended by the keynote lectures mentioned below:

Jacob Joseph, Howard Medical School, USA

Ujwala Vilas Salvi, Nucleon Therapeutics LLP, Mumbai (India)

Chi Chen, Partner at E&Y,CHINA

Rajiv Joshi, Director and Assuranc. ,E &Y

Carole Gabay¸ DRcomGroup ,China

Fawad Piracha, Regeneron Pharmaceuticals, Inc ,USA

Conference Series LLC Ltd wishes to acknowledge with its deep sincere gratitude to all the supporters from the Editorial Board Members of our Open Access Journals, Keynote speakers, Valuable speakers, students, delegates for their contribution to make this event a huge success.

We once again thank you all for the enormous exquisite response. This inspires us to continue organizing events and conferences for furthering the pharmacovigilance Research. Conference Series LLC ltd therefore, is glad to announce its Annual Meet on Pharmacovigilance & Drug Safety scheduled during March 24-25, 2022 Rome, Italy.

 

To Collaborate Scientific Professionals around the World

Conference Date June 07-08, 2022

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