10th Pharmacovigilance Congress
"Conference Series LLC organizing gratifying Pharmaceutical conferences welcomes you to attend the 10th Pharmacovigilance Congress to be held during September 20-21, 2017 in Charlotte, USA focuses on the advancements in Pharmacovigilance, Drug Safety and Risk management. The field of Pharmacovigilance is growing rapidly and its development is making immense impacts in medical sciences and pharmaceuticals. Pharmacovigilance Congress accentuates 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. The main theme of 10th Pharmacovigilance Congress was “Ensuring Drug Safety in Healthcare System”.Impact of advanced therapies and technologies on pharmacovigilance practice and risk management in compliance with the latest regulatory framework.10th Pharmacovigilance Congress will be organized around the theme “Impact of advanced therapies and technologies on pharmacovigilance practice and risk management”Pharmacovigilance Congress 2017 is comprised of keynote and speakers sessions on latest cutting-edge research designed to offer comprehensive global discussions that address current issues in Pharmacovigilance Congress 2017 .The Pharmacovigilance conference organised yearly by Medicines for Europe, is a unique event where key stakeholders gather with the aim of promoting patient safety and undertaking to continue work towards a more efficient pharmacovigilance system. In the spirit of constructive cooperation, this event brings together representatives from the industry and regulators as well as healthcare professionals and patient organizations.Morning sessions reflect on achievements so far and focus on the milestones ahead. An open dialogue between key stakeholders has proven to be the right approach for making significant progress towards better pharmacovigilance for better public protection.[1]
Contents
Conference Headlights:
- Pre-clinical and clinical trials.
Preclinical research also named preclinical studies and nonclinical studies is a stage of research that begins before clinical trials, and during which important feasibility, iterative testing and drug safety data is collected. The main goals of pre-clinical studies are to determine the safe dose for the First-in-man study and start to assess product's safety profile. Products may include new or iterated or like-kind medical devices, drugs, etc.. Clinical trials are conducted to collect data regarding the safety and efficacy of new drug and device development. There are several steps and stages of approval in the clinical trials process before a drug or device can be sold in the consumer market, if ever. Postmarketing study commitments are studies required of or agreed to by a sponsor that is conducted after FDA has approved a product for marketing. FDA uses postmarketing study commitments to gather additional information about a product's safety, efficacy, or optimal use. Clinical trials are also known as clinical research studies that follow a pre-defined plan or protocol. Researchers design clinical trials (Clinical study designs) to answer specific research questions related to a medical product. Clinical trials, particularly those looking at new drugs, often start after successful animal studies. The most promising treatments then move into clinical trials. There are four categories of clinical trials. The fourth occurs after the FDA has cleared a certain drug or therapy and continues to track the safety of the treatment. Phase 1, Phase 2, Phase 3 and Phase 4. A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. Test potential treatments in human volunteers to see whether they should be approved for wider use in the general population. A treatment could be a drug, medical device, or biologic, such as a vaccine, blood product, or gene therapy. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research.
- Adverse drug reactions
The Adverse Drug Reactions, Drug Interactions and Pharmacovigilance course is a one-week module of the MSc in Experimental Therapeutics. Offered by the Department of Oncology and the Department for Continuing Education’s CPD Centre, the teaching will be led by Dr Michael Theodorakis, Radcliffe Department of Medicine, University of Oxford, and will feature face-to-face lectures and tutorials from some of the country's leading clinicians and scientists.
- Clinical trials on various disorders
The module can be taken as a stand-alone short course. It includes group work, discussions, guest lectures, and interaction and feedback with tutors and lecturers.
- Pharmacovigilance and risk management - The World Health Organization (WHO)
Defines pharmacovigilance as the science and activities relating to the detection, evaluation, understanding, and prevention of adverse reactions to medicines or any other medicine-related problems. The definition and scope of pharmacovigilance have evolved to recognize the importance of a systems approach for monitoring and improving the safe use of medicines.A simpler definition describes pharmacovigilance as the processes and science of monitoring. The safety of medicines and taking action to reduce risk and increase benefit.2 Therefore, the assessment of benefit versus risk must begin during the preclinical evaluation of a medicinal product and must extend throughout its full life cycle. Therefore it is essential in building capacity for clinical trials to understand the components, the functions, and the processes required for full and effective pharmacovigilance and risk management.
- Good pharmacovigilance practice - Good pharmacovigilance practices (GVP)
A set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in the EU Member States. They cover medicines authorised centrally via the Agency as well as medicines authorised at the national level.
- Pharmacovigilance significance and scope
The main aim of pharmacovigilance is to provide complete and clear information related to drug safety and various risks and benefits associated with them. Pharmacovigilance can help in providing information of unintended and severe adverse events which could not be provided by clinical trials involving in-vivo method.
- Case report in clinical trials
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. There are two types of CRFs used in clinical research, that is, traditional paper CRF and improvised electronic CRF (eCRF). Paper CRF is the traditional way of data capture and a better option if studies are small or vary in design, whereas eCRFs are considered if studies are large with similar designs. In the current global scenario, eCRFs are preferred over paper CRFs as they are less time-consuming, and also encourage the sponsor/pharmaceutical company to carry out large multicentric studies at the same time due to the ease of administration. It is designed in such a way that data entry can be done with zero/minimal errors. Moreover, the regulatory authorities are readily accepting submissions in which validated electronic data capture (EDC) systems are used.
- Drug safety
- 'Data quality management and analysis
- Diversity in industrial clinical trials and clinical research
- Clinical research and statistics
- Bio pharmaceutical sciences
- PV consulting and business
- Opportunity
- Regulatory affairs
- Pharmacy practices and challenges
- Entrepreneurs Investment meet
Conference Highlights
Drug Safety
Adverse Drug Reactions
Clinical Data Management
Case Study
Good Pharmacovigilance Practice
Pharmacovigilance Risk management plans and new risk- benefit analysis tools
Pharmacokinetics and Pharmacodynamics
Overview of Clinical Trials and Post Marketing
Preclinical and Clinical Trials on Various Disorders
Case Report in Clinical Trials
Pharmacovigilance on Biopharmaceutics
PV Data Base Managemaent
PV Consultings And Bussiness Opportunity
Regulatory Affairs
Growth Strategies in Pharma
Pharmacy Practices and its Challenges
About Conference:
Conference organized by Conferenceseries
ConferenceSeries Ltd organizing gratifying Pharmaceutical conferences, welcomes you to attend the 10thPharmacovigilance Congress to be held during September 20-21, 2017 in Charlotte, North Carolina, USA focuses on the advancements in pharmacovigilance and risk management.
The field of Pharmacovigilance is growing rapidly and its development is making tremendous impacts in medical sciences and pharmaceuticals. Pharmacovigilance Congress 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 name recognition at this 3-day 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
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.
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 name recognition at this 3-day event. World-renowned speakers, the most recent techniques, developments, and the newest updates in Pharmacovigilance are hallmarks of this conference. The Pharmacovigilance conference organised yearly by Medicines for Europe, is a unique event where key stakeholders gather with the aim of promoting patient safety and undertaking to continue work towards a more efficient pharmacovigilance system. In the spirit of constructive cooperation, this event brings together representatives from the industry and regulators as well as healthcare professionals and patient organisations. Conference Series invites all the participants across the globe to attend '10th Pharmacovigilance Congress ' during September 20-21, 2017 Charlotte, USA. which includes prompt keynote presentations, Oral talks, Poster presentations and Exhibitions.PVCON 2017 aims to provide a forum for international researchers from various areas of pharmacy, pharmaceutical sciences, by providing a platform for critical analysis of new data, and to share latest cutting-edge research findings and results about all aspects of Pharmacy meeting.Pharmacovigilance domain is experiencing a rapid growth. Morning sessions reflect on achievements so far and focus on the milestones ahead. An open dialogue between key stakeholders has proven to be the right approach for making significant progress towards better pharmacovigilance for better public protection.
E-Mail us at
pharmacovigilancecongress@conferenceseries.net
willthomas@conferencesamerica.org
pharmacovigilance@conferencesamerica.org
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