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As per available reports about10 relevant journals, 71 Conferences, 6 workshops are presently dedicated exclusively to regulatory issues and about 1543 articles are being published on regulatory issues.
The pharmaceutical sector is a dynamic, research-intensive industry that is fundamentally influenced by a web of regulations designed to a)promote research and innovation in the design and production of drugs, b) protect consumers from potentially harmful effects of drugs, and c)to control public and private expenditure on drugs. These objectives are sometimes in conflict and may require a balancing of the interests of producers and consumers. Since most consumers have some form of health insurance, their incentives to control their purchasers of pharmaceuticals or to purchase from the most efficient pharmacist are limited. Health insurers seek to control pharmaceuticals expenditure through various policies such as co-payments, lists of approved drugs and maximum reimbursement levels for different drugs. If reimbursement levels for pharmacists are set at a national or regional level, incentives for entry by new pharmacists are excessive in certain locations, typically leading to restrictions on the establishment of new pharmacies. Well thought out reform of this industry has the potential to reduce pharmaceutical expenditures while maintaining the quality of the drugs consumed.
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Scope and Importance
Center for Regulatory Effectiveness - Emerging Regulatory Issues: The mission of the CRE is to ensure that the public has access to data and information used to develop federal regulations, and to ensure that information which federal agencies disseminate to the public is of the highest quality. Here it keeps a record of all the federal regulations includind issues related to Drug Regulations. The Emerging Regulatory Issues section is designed to make readers aware of societal developments which have the potential to lead to federal government regulation. Although any individual topic might not ultimately result in an agency rulemaking, awareness of such issues may be beneficial from a regulatory strategy standpoint. Also by being aware of such potential problems, industry can craft its own workable solutions before regulatory solutions are imposed from outside. CRE welcomes insights on these topics and suggestions of other issues which might be added to this list.
FDA/Center for Drug Evaluation and Research - Guidances & Enforcement Information: The mission of CDER is to assure that safe and effective drugs are available to the American people. Here it gives information on Regulatory & Scientific Guidances and legislation on drug products. Guidance, Compliance, & Regulatory Information: Affordable Care Act (ACA 6004), Bioequivalence Recommendations for Specific Products, Compounding, Drug Compliance Programs, Guidances (Drugs), Newly Added Guidance Documents, Nicotine-Containing Products, Notice to Industry: Postmarketing Requirements - Postmarket studies and clinical trials, Office of Compliance, The Office of Prescription Drug Promotion (OPDP), PLR Requirements for Prescribing Information, Regulatory Guidance Drug Registration and Listing, Unapproved Prescription Drugs: Drugs Marketed in the United States That Do Not Have Required FDA Approval, Warning Letters and Notice of Violation Letters to Pharmaceutical Companies.
World Health Organization - Drug regulation: The mission of WHO is the attainment by all peoples of the highest possible level of health. Here it gives ingormation on various means to achieve Effective drug regulation.Medicines regulatory support: Effective medicines regulation promotes and protects public health by ensuring that: medicines are of the required quality, safety and efficacy; medicines are appropriately manufactured, stored, distributed and dispensed; illegal manufacturing and trade are detected and adequately sanctioned; health professionals and patients have the necessary information to enable them to use medicines rationally; promotion and adverting is fair, balanced and aimed at rational drug use; access to medicines is not hindered by unjustified regulatory work.
The market was valued at US$1.56 billion in 2013 and is estimated to reach a value of US$4.49 billion by the end of 2020.With the help of regulatory affairs outsourcing, life science, pharmaceutical, and medical device manufacturing companies are able to get their drugs or devices approved or launched in the global market. Regulatory affairs outsourcing by biopharmaceutical companies has minimized losses due to recalls and product approval delays. Regulatory affairs service providers also provide effective services such as clinical trial services, medical writing, and pharmacovigilance to biotech, pharma, and medical device companies.
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This page was last updated on 14th Sep, 2015
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