Sessions And Tracks
Track1: Drug Development and Drug Discovery
Healthcare systems constantly need new pharmaceuticals to treat unmet medical needs in a variety of therapeutic areas, and pharmaceutical industries primarily work to bring new drugs to market through the challenging processes of drug research and development. The process of discovery includes several steps, including the selection of the target and its validation, the identification of hits, the generation and optimization of leads, and the identification of a candidate for further development. Contrarily, development entails improving chemical synthesis and formulation, doing animal toxicology studies, conducting clinical trials, and ultimately receiving regulatory permission. Both of these procedures take a lot of time and money, and the business is currently under pressure due to incredibly strict regulatory requirements, environmental concerns, and decreased profits as a result of patent expirations.
Track2: Pre-Clinical Research
Researchers must ascertain a drug's potential for toxicity, also known as serious harm, prior to testing it on humans. Preclinical research is divided into two categories: in vitro and in vivo.
Preclinical investigations are typically not very big. These studies must, however, offer thorough information on dosage and toxicity levels. Researchers evaluate the results of preclinical testing and determine whether human testing of the medicine is necessary.
Track3: Pharmacovigilance
Pharmacovigilance is the study and practise concerned with the identification, evaluation, comprehension, and avoidance of side effects or any other issue with drugs or vaccines. Before being approved for use, all medications and vaccines go through extensive clinical trials to test their safety and efficacy.
There are four important methods in Pharmacovigilance such as,
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Passive surveillance.
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Active surveillance.
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Cohort event monitoring.
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Targeted Clinical Investigations.
Track4: Clinical Study Designs
The design of trials, experiments, and observational studies in medical, clinical, and other fields of research (such as epidemiology) involving people is known as clinical study design. A clinical study's objective is to evaluate the effectiveness, safety, and/or mechanism of action of an investigational medicinal product (IMP), technique, novel medicine, or technology that is being developed but may not yet have received approval from a health authority (e.g. Food and Drug Administration). A drug, device, or procedure may also be investigated if it has already been approved but needs more research, typically in order to determine its long-term effects or cost-effectiveness.
Track5: Clinical Data Strategy and Analytics
The collection, analysis, and utilisation of data on clinical performance and outcomes are crucial to enhancing the safety and quality of patient treatment. Access to well-defined sets of safety and quality information that have been collected and synthesised into indicators that are simple for physicians, managers, patients, and executives to utilise is necessary for health services.
Clinical Data Strategy is 4 streams of work:
Stream 1: Assessing and keeping track of the effectiveness of Transforming Health
Stream 2: Creating and employing a set of management and clinical standards
Stream 3: Creating and utilising particular clinical indicators for various clinical specialisations
Stream 4: Building knowledge and abilities for managers and clinicians to improve quality using data
Track6: Clinical Data Management
A vital step in clinical research is clinical data management (CDM), which produces high-quality, trustworthy, and statistically sound data from clinical trials. This results in a significantly shorter period of time between drug development and launch.
Track7: Clinical Safety Data
Clinical Safety Data refers to all safety-related information, including safety reports containing details on adverse events, SAEs, compilations and analyses to meet any FDA reporting requirements, and summary tables of laboratory and radiographic data. It also includes results from the Monotherapy Arm.
Track8: Medical Writing
A medical writer, also known as a medical communicator, employs clinical research methods to create clinical trial materials that succinctly and precisely convey research findings, product use, and other medical information. Any one of the five modules of the Common Technical Document is created by the medical writer. In terms of content, format, and structure, the medical writers also make sure that their documents adhere to any applicable regulatory, journal, or other criteria.
Track9: Data and Technology in Clinical Trials
There are numerous major clinical trial challenges that technology has made easier. Faster hiring and greater employee retention, enhanced patient care, enhanced patient data collection, accessibility to non-traditional data sets, and remote patient monitoring are a few of these.
By enabling other researchers to do further studies that offer reliable scientific knowledge regarding the efficacy and safety of the study intervention, clinical trial data aids patients.
Track10: Clinical Trial Management
In order to manage clinical trials for clinical research, the biotechnology and pharmaceutical sectors utilise a clinical trial management system (CTMS). Along with participant contact information, tracking deadlines and milestones, the system maintains and controls planning, executing, and reporting activities.
Track11: Clinical Development and Vaccines
The entire process of introducing a novel drug or device to the market is referred to as clinical development, sometimes known as drug development. It covers pre-clinical research using animals or microbes, clinical trials, and drug discovery and product development (on humans).
In the laboratory, a vaccine candidate goes through development and research for two to five years. First, the pathogen is examined, and it is determined which elements of the virus the human immune system can recognise and respond to in order to develop defence (antibodies). Development of the vaccine and small-scale manufacturing for more animal and human vaccine testing come next.
Track12: Digital Technology in Clinical Trials
Utilizing digital technology to enhance participant access, engagement, trial-related measurements, and/or interventions, as well as to enable concealed randomised intervention allocation, is the idea behind a "digital clinical trial," which has the potential to transform clinical trials and reduce their cost.
Track13: Transitional and Experimental Clinical Research
With the help of translational research, scientific advancements made in the lab, clinic, or field are turned into fresh medical procedures and methods that enhance community health.
Clinical trials are research projects conducted on human subjects with the goal of assessing a therapeutic, surgical, or behavioural intervention. They are the main method used by researchers to determine whether a new treatment, such as a new medication, diet, or medical gadget (such as a pacemaker), is safe and effective in humans.
Track14: Post Marketing Surveillance
Postmarketing surveillance, a crucial component of the science of pharmacovigilance, is the process of keeping track of a pharmaceutical drug's or medical device safety after it has been put on the market. Post marketing surveillance can further refine, or confirm or deny, the safety of a drug or device after it has been used in the general population by large numbers of people who have a wide variety of medical conditions. Because drugs and medical devices are approved on the basis of clinical trials, which involve relatively small numbers of people who have been selected for this purpose and typically do not have other medical conditions that may exist in the general population.
Track15: Regulatory Affairs
Regulatory affairs (RA) scientists are involved with overseeing the process of getting a drug or product through the FDA review and approval process and onto the market. Since every step in the process of product development is highly regulated, those in RA work at each step to move a drug from research and development through FDA approval. They act as liaison between companies and the Food and Drug Administration (FDA).
Track16: Globalization of Clinical Trials
A variety of studies are now being conducted on a global basis as a result of the globalisation of clinical research, which has led to a sharp rise in the number of clinical trials in developing nations. Therefore, the process of expanding clinical trials internationally may be advantageous because, for instance, it provides participants with access to novel treatments; however, it necessitates discussion and oversight of ethical issues related primarily to ensuring the integrity, welfare, and safety of research participants; to the bioethical frames of reference of autonomy, nonmaleficence, beneficence, justice, and fairness.
Track17: AI in Clinical Trials
By examining medical records and social media posts, AI can find cohorts that are appropriate for clinical studies. By employing AI technology to notify medical professionals and patients about trial chances and by making entrance requirements simpler so that they are more approachable for potential participants, trial recruitment can be sped up.
Track18: Drug related problems in healthcare
Medication errors (errors in the prescription, dispensing, or administration of a drug, whether or not they have negative effects) and adverse drug reactions are two examples of issues related to drugs (any response to a drug which is noxious and unintended, and which occurs at doses normally used in humans for prophylaxis, diagnosis or therapy of disease, or for the modification of physiological function).
Track19: Oncology Clinical Research
Clinical trials are research projects that contrast the best successful treatment currently available for a particular type or stage of cancer with a novel strategy. This could be a novel medication, a medicine cocktail, or an alternative method of administering tried-and-true treatments.
Track20: Latest technologies in Biomedical Research
The greatest way to move science forward, develop new products and therapies, treat, cure, and prevent illness is currently through an integrated approach using chemical, scientific, and PC simulations, in vitro tests, whole animal models, human epidemiological studies, and clinical trials. Concoction, mechanical, numerical, and PC simulations are most useful during the planning stages of research where they help strengthen ideas about new research directions. These are strong test models, but research centre testing cannot be replaced by them. PC replicas are an efficient research tool since they speed up and make use of already available material. Research centre data on the efficacy and safety of novel treatments or vaccines are used in human examinations to evaluate them in carefully planned clinical trials with knowledgeable human participants.
Market Analysis
Therapeutic Trials the market size was USD 53.9 billion in 2021, and it is anticipated to increase at a CAGR of more than 4.9% from 2022 to 2030. The global market is expanding primarily because to the rising prevalence of chronic diseases and the rising demand for the creation of novel medications and treatments.
SOCIETIES AND ASSOCIATIONS:
Association of the British Pharmaceutical Industry
American College of Clinical Pharmacology
Association of Clinical Research Professionals
American Society for Clinical Pharmacology and Therapeutics
British Association of Research Quality Assurance
Clinical Contract Research Association
Consortium of Independent Review Boards
The Center for Information & Study on Clinical Research Participation
Drug Information Association
European Forum for Good Clinical Practice
The Institute of Clinical Research
International Federation of Associations of Pharmaceutical Physicians
International Society for Clinical Biostatistics
Pan-Asian Clinical Research Association
Public Responsibility in Medicine and Research
Statisticians in the Pharmaceutical Industry
Regulatory Affairs Professionals Society
Society for Clinical Data Management
Society for Clinical Data Management
Society of Clinical Research Associates
Society of Pharmaceutical Medicine
Society for Applied Pharmacological Sciences
The Organization for Professionals in Regulatory Affairs