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 delivery, Sustained 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 Europe: European 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 USA: American 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 Europe: Royal 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 Pacific: Chemical 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
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.