11th Annual Congress on Pharmacovigilance and Clinical Trials
|11th Annual Congress on Pharmacovigilance and Clinical Trials
|March 28-29, 2018
|Orlando, Florida, USA
"Conference Series LLC welcomes you to attend the 11th Annual Congress on Pharmacovigilance and Clinical Trials to be held in 2018 in Orlando, Florida, USA, focusing on safer drug innovations and critical considerations in clinical trials. The field of pharmacovigilance is growing rapidly and its development is making tremendous impacts in medical sciences and pharmaceuticals."
"This will be 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 2-day event. World-renowned speakers, the most recent techniques, developments, and the newest updates in Pharmacovigilance are hallmarks of this conference."
- Pharmacovigilance and Drug Safety
- Pre-Clinical and Clinical Trials
- Pharmacodynamics and Pharmacokinetics
- Clinical Data Management:
- Adverse Event Reporting
- Clinical and Medical Case Reports
- Pharmacovigilance Data Base Management
- Clinical Trial Regulatory Challenges
- Data Quality Management and Analysis
- Design of Clinical Studies and Trials
- Clinical Research
Clinical trial phases
"The entire process of moving a drug from design to clinical trials takes 10 to 12 years on average." Let’s take a closer look at each stage to better understand what goes into early clinical development and preparation for approval of a drug. Preclinical studies Deciding whether a drug is ready for clinical trials (the so-called move from bench to bedside) involves extensive preclinical studies that yield preliminary efficacy, toxicity, pharmacokinetic and safety information. Wide doses of the drug are tested using in vitro (test tube or cell culture) and in vivo (animal) experiments, and it is also possible to perform in silico profiling using computer models of the drug–target interactions. Much like for clinical trials, there are certain types of trials that have to be done, such as toxicology studies in most cases, and other trials that are specific to the particular study compound or question. Understanding that the goal of preclinical trials is to move into the clinical stage is key and the studies should be designed around that goal. Watch our webinar on moving from preclinical to clinical trials. Don't get too worked up on too many preclinical trials that may not be necessary but make sure to consult with experts who can help you decide, which trials you should do and if you are ready to move into clinical stage. At Profil we have a team of experts who can advice you on such questions and who will help you with the transition into clinical trials. Contact us to start the discussion. Phase 0 clinical trial Phase 0 involves exploratory, first-in-human (FIH) trials that are run according to FDA guidelines. Also called human microdose studies, they have single sub-therapeutic doses given to 10 to 15 subjects and yield pharmacokinetic data or help with imaging specific targets without introducing pharmacological effects. Pharmaceutical companies perform Phase 0 studies to decide which of their drug candidates has the best pharmacokinetic parameters in humans. Phase I–IV versus early and late phase clinical trials Clinical trials involving new drugs are commonly classified into four phases. However, they can also be classified as early phase clinical trials and late phase trials because there can be overlap between phases. Profil Germany focuses on phase 1+2 clinical trials as we are a full-service CRO for early clinical development. Phase I Phase I trials are the first tests of a drug with a small number of healthy human subjects. Patients are generally only used if the mechanism of action of a drug indicates that it will not be tolerated in healthy people – for example, if it induces pronounced hypoglycemia. They are primarily designed to assess the safety and tolerability of a drug, but the pharmacokinetics and, if possible, the pharmacodynamics are also measured. The typical phase I trial has a single ascending dose (SAD) design, meaning that subjects are dosed in small groups called cohorts. Each member of a cohort might receive a single dose of the study drug or a placebo. A very low dose is used for the first cohort. The dose is then escalated in the next cohort if safety and tolerability allow. Dose escalation is stopped when maximum tolerability and/or maximum exposure is reached. SAD studies are usually followed by multiple ascending dose (MAD) studies, which have a very similar design, with cohorts and escalating doses. The only difference is that the subjects receive multiple doses of the study drug or placebo. While safety and tolerability are still important endpoints, the multiple dose setting often allows first investigations of the pharmacodynamic effects in addition to the pharmacokinetics. Depending on the risk potential and the safety and tolerability revealed by the SAD study, many MAD studies may already involve patients rather than healthy individuals. That said, it is important to enroll a relatively healthy patient population with as few complications and concomitant diseases as possible. Finally, food effect studies are often conducted to investigate the potential impact of food intake on the absorption of the drug. These studies are usually run as a crossover study, with volunteers being given two identical doses of the drug, one after fasting and one after a meal. Phase II Phase II trials are performed on larger groups of patients and are designed to assess the efficacy of the drug and to continue the phase I safety assessments. Most importantly, phase II clinical studies help to establish therapeutic doses for the large-scale phase III studies. Phase II studies are sometimes divided into phases IIA and IIB. Phase IIA is designed to assess dosing requirements whereas phase IIB focuses on drug efficacy. The exact design of phase II studies depends heavily on the compound's mechanism of action. A proof-of-concept study should be included in phase II if it has not already been done during the MAD-study in phase I. In addition, a treatment study with several different doses of the compound in comparison with a placebo and/or an active comparator over a treatment duration of 12 to 16 weeks is usually an essential part of the phase II program. Phase III Phase III investigates the efficacy of a new drug over 6 to 12 months in a large patient population (several hundred patients or more) under conditions that reflect daily clinical life much more closely than the phase I or II trials. These trials are usually done on an outpatient basis with no in-house days and include an active comparator, at least in the case of metabolic diseases, because exposing patients to several months of placebo treatment would not in general be ethical. Because of their size and comparatively long duration, Phase III trials are the most expensive, time-consuming and difficult trials to design and run, especially in therapies for chronic medical conditions. Therefore, drugs that do not show promising results in phase II are often not pursued in phase III. In fact, only 18% of drugs in phase II proceed to phase III. Phase IIIA studies are used for the approval of the drug. The results of these studies are fully included in the submission package to regulatory authorities. Between submission and approval, phase IIIB studies are often performed to obtain additional safety data or to support marketing claims for the drug. Phase IV Phase IV trials are also known as post-marketing surveillance trials involving safety surveillance (pharmacovigilance) and ongoing technical support after approval. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive purposes or other reasons.
Sessions/Tracks With the grand success of Pharmacovigilance Series of Conferences in UK, USA in consecutive years over the last several years which met with great achievement in Business Conferencing. It’s glad to announce 8th Global Pharmacovigilance & Drug Safety Summit during July 6-7, 2017 in Kuala Lumpur, Malaysia with the theme “Innovations in Pharmacovigilance for Systematic safety and Management”.This is a 2 day Mega Event offering Exhibition, at venue to showcase the new and emerging technologies with Keynote presentation, Oral, YRF (Student Presentation), poster, e-poster Presentations. Track 1: Drug Safety
Concept of drug safety is also known as Medication Safety in the field of health. It is associated with adverse effects of Pharmaceutical products involving many other scientific aspects, such as the side effects of drugs, the quality of medications, medication error in usage of drugs, lack of efficacy of drugs, and counterfeit drugs. Patient Safety, Drug Interaction (drug–drug and food–drug interaction) Drug Pharmacokinetic, and Adverse Drug Reaction are several terms involved with Drug Safety. Companies have to conduct a complete drug safety and pharmacovigilance audit to gauge their compliance with international standards of laws, regulations, and guidance.
In this track we will be focusing on, "Drug Safety Updates, Drug Safety Solutions, Training, Surveillance, Services & Software, Reporting & Monitoring. Related Drug Safety Events | Drug Safety Conferences | Pharmacovigilance Conferences"
8th International Conference on Proteomics and Bioinformatics, May 22-24, 2017 Osaka, Japan ; Pharmacovigilance & RMS Summit June 6-7,2017, Washington, USA; 8th Asian Biosimilars Congress August 14-16, 2017 Osaka, Japan; Risk Mangement and Pharmacovigilance Summit 2017, September 12-14, 2017 Vienna; 19th International Conference on Biomarkers and Clinical Research September 7 - 8, 2017, Tokyo, Japan; Global Pharmaceutical Regulatory Affairs Summit October 24-26 2017, Prague; 9th Annual Congress on Drug Formulation & Drug Design, October 19-20, 2017 Seoul, South Korea; 16th Annual Medicinal & Pharmaceutical Sciences Congress October 19-20, 2017 Seoul, South Korea; 3rd International Conference on Transcriptomics, October 30 - November 01, 2017 Bangkok, Thailand ; 19th International Conference on Clinical Research Informatics, Management and Health Science, Kyoto, Japan; Pharmacovigilance Europe 2017, May 24-25 2017, London UK