Recommended Global Pharma Marketing & Industry Conferences
GMP Summit 2018
Good Manufacturing Practice is the part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate of their intended use and as required by the marketing authorization, clinical trial authorization or product specification. Good Manufacturing Practices Conference aims at both production and Quality Control. Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent to pharmaceutical manufacturing in order to ensure the quality, safety and efficacy of products. FDA regulates the quality of pharmaceuticals very carefully. Current trends in the FDA are the main regulatory standard for ensuring pharmaceutical quality.
Role of pharmaceutical inspection convention and co-operation scheme (PIC/S) is to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry. The FDA regulations and CFR are responsible for protecting and promoting public health through the regulation and supervision of all the products available in the market to ensure patient compliance. EU-GMP guidelines are needed to maintain the products quality which is stricter when compared to WHO-GMP guidelines.
cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US FDA. cGMPs provide for systems that assure proper design, monitoring and control of manufacturing processes and facilities. Adherence to the cGMP regulations assure the identity, strength, quality and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.
The purpose of the GxP quality guidelines is to ensure that a product is safe and meets its intended use. GxP guides quality manufacture in regulated industries including food, drugs, medical devices and cosmetics.
Track-4: The Role of 'c' in cGMP
The cGMP requirements were established to be flexible in order to allow each manufacturer to decide individually how to best implement the necessary controls by using scientifically design, processing methods, and testing procedures. The flexibility in these regulations allows companies to use modern technologies and innovative approaches to achieve higher quality through continual improvement. Accordingly, the "c" in cGMP stands for "current," requiring companies to use technologies and systems that are up-to-date in order to comply with the regulations. Systems and equipment that may have been "top-of-the-line" to prevent contamination, mix-ups, and errors 10 or 20 years ago may be less than adequate by today's quality standards.
The role of ICH in designing GCP principles is to provide an ethical treatment to the subjects who are involved in the clinical trials. Conference on Good Clinical Practices is important because it is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. The GLP Principles describe requirements for and provide general guidance on the conduct of all nonclinical health and environmental safety studies, including in vitro studies. Pre-clinical trials assess the toxicity of a drug and examine its potential effects on the human body. These trials are conducted in-vitro which is required to proceed with clinical trials. Good laboratory practices should be followed for these pre-clinical trials.
Track-6: Quality Control
Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria that meets the requirements of the client or customer. A major aspect of quality control is the establishment of well-defined controls. These controls help standardize both production and reactions to quality issues. The role of Quality Impact Assessment and effectiveness checks is an essential operation of the pharmaceutical industry. To perform Quality Control process of project management several quality control tools and software’s are required. Quality control also plays a major role in analytical method development so it would be great to attend the quality control summit.
Track-7: Quality Assurance
Quality assurance is defined as a procedure or set of procedures intended to ensure that a product or service under development meets its specified requirements. A quality assurance system is said to increase customer confidence and a company's credibility, to improve work processes and efficiency, and to enable a company to better compete with others. Quality assurance conferences aim at the need for Effective Internal and External Quality Assurance Auditing and it is required, by all active pharmaceutical ingredient (API)/bulk pharmaceutical chemical, medical device and finished pharmaceutical cGMP regulations published worldwide. Quality assurance testing is done by using software called Quality Metrics.
Validation means establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product, thus meeting its predetermined specifications and quality attributes. Validation is an integral part of quality assurance; it involves the systematic study of systems, facilities and processes aimed at determining whether they perform their intended functions adequately and consistently as specified. The major phases of validation include Pre-validation, Process Validation and Validation maintenance Phase.
Traditional role of contract manufacturing, also known as outsource manufacturing, is to produce one or more components of a final product in which a company relies on the skills of specialist manufacturers. Six sigma is a long-term, forward-thinking initiative designed to fundamentally change the way corporations do business. It is first and foremost "a business process which enables companies to increase profits dramatically by streamlining operations, improving quality, and eliminating defects or mistakes in everything a company does”. Aseptic/sterile production and injectable manufacturing processes require a significant investment in terms of expertise, equipment, process, technology and quality control.
Track-10: Storage, Distribution, Transportation
Cold chain storage is a temperature-controlled supply chain. An unbroken cold chain is an uninterrupted series of storage and distribution activities which maintain a given temperature range. It is used to help extend and ensure the shelf life of pharmaceutical drugs. Good distribution practice (GDP) deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption. Supply Chain integrity, enable qualified firms to expedite the importation of active pharmaceutical ingredients and finished drug products.
Track-11: Formulation Development
Formulation development is to be done only after successful completion of pre-formulation studies. Optimization of existing formulations is required to create new products, reduce costs, to capitalize on trends with greater profitability, novel formulations for improved delivery of existing dosage forms, to quickly recalculate formulations based on defined criteria, to create compliant products faster by using existing validated formulas. Product/process optimization is the practice of making changes or adjustments in a process such as Conjoint Analysis, typically used in industrial process optimization.
Track-12: GMP in Food Industry
The Quality control in typical food processing industries have a significant role in assuming a high quality, safe and nutritious food supply for the public, for their good health and for the economic benefits derived from trade of safe and high quality food. Quality control conference also plays a major role in food industry. Hazard Analysis and Critical Control Points (HACCP) is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. Food, Drug, and Cosmetic Act is a set of laws giving authority to the US-FDA to oversee the food safety, safety of drugs, and cosmetics. Cleaning, disinfection and hygiene should be strictly maintained in food industry.
Track-13: GMP in Microbiology and Biotechnology
Microbiological assay is defined as the determination or estimation of concentration or potency of an antibiotic by means of measuring and comparing the area of zone of inhibition or turbidity produced by test substance with that of standard over a suitable microbe under standard conditions. FDA 510k Testing regulation is found in 21 CFR 807 includes information required in a 510(k). The 510 (k) is not a form. Cleaning, disinfection and hygiene should be strictly maintained in Microbiology and Biotechnology.
Track-14: Softwares in GMP and GCP
The use of GMP software systems in regulated industries is vital throughout all aspects of the manufacturing process. Quality management software provides a flexible and configurable platform for tracking and managing quality and regulatory compliance events to ensure that manufacturing activities are continually measured, monitored and improved upon. In addition to managing all aspects of the audit process, GMP software solution manages the associated findings or observations, corrective and preventive actions (CAPAs), risk assessment, risk management and the analysis and approvals of changes. This software also manages deviations, process validation, complaint handling, manufacturing incidents, training records and more.
An administrative science driven administrative procedure is crucial as a component of today's biopharmaceutical item early advancement arranging. An all-around arranged administrative methodology will adjust the proposed clinical advancement arrangement with business targets, and pre-emptively distinguish challenges, and also, proposed elective/creative ways to deal with new item improvement which influence new measures for confirmation era supporting proceeding with improvement and worldwide business sector approval. An administrative methodology characterizes key issues/difficulties to proactively talk about Regulatory powers which furthermore characterize key system points of reference that are frequently considered business impetuses driving speculator intrigue and financing. In particular, very much arranged and all around kept up administrative technique, with proactive and collective cooperation with administrative powers, is regularly a separating element for industry pioneers putting up monetarily fruitful and creative items for sale to the public in today's aggressive commercial centre. Administrative procedure is a noteworthy segment of fruitful biopharmaceutical item improvement. Covance Global Regulatory Affairs gets ready and keeps up administrative science driven and item particular worldwide administrative systems for some item sorts, e.g., drugs, biologics, drug-gadget mixes, antibodies, quality treatments, cell-treatments, over a scope of restorative territories and full administrative technique support for item improvement activities.
Excipients play an important role in formulating a dosage form. These are the ingredients, which along with active pharmaceutical ingredients make up the dosage forms. Excipients act as protective agents, bulking agents and can also be used to improve bioavailability of drugs in some instances, Excipients affect the physicochemical characters of the active pharmaceutical ingredient which may lead to formation of molecular complexes, increase in rate of chemical degradation etc.
GMP Summit 2018 is the learning of ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Advanced studies are being made to improvise quality of products, reduce safety risk and cost, and enhance international credibility and public image and many more.
Good Reasons Not to Miss GMP Summit 2018
1. You can listen to Industry manufacturing experts.
2. The program focuses both on scientific value and impact on the industrial world.
3. You can meet companies and stakeholders in the pharmaceutical product development field.
Who Should Attend and Who You’ll Meet ?
Directors/Senior Directors/Executive Directors and Vice Presidents/ Senior Vice Presidents /patents/attorney/Executive Vice Presidents and Heads/Leaders/Partners of
Clinical Research Sites
Pharma/Biotech/Biosimilars/Medical Devices manufacturing departments
Quality Analysts, Consultants
Clinical research associates, Quality control analysts, Medical Directors, Principal Investigators, Methodologists, and other Regulatory professionals along with Academicians: University Faculties like Directors, Senior Professors/Assistant Professors/ Associate Professor, Research Scholars, scientists who are related to clinical and medical research.
Industry professionals with responsibilities in:
· Current Good Manufacturing Practices
· Quality Assurance
· Clinical Trial Management/Clinical Trial Supplies
· Clinical Research & Development
Global Market Analysis for GMP:
The global market for pharmaceutical and biopharmaceutical contract manufacturing, research and packaging was $219.9 billion in 2012. This market is estimated to reach $242.2 billion in 2013 and $374.8 billion by 2018, a five-year compound annual growth rate (CAGR) of 9.1%.
• Global spending on medicines is forecast to reach nearly $1.3 trillion by 2018
• 21 pharmerging countries will increase their contribution to growth over the next five years and account for nearly 50% of absolute growth in 2018.
• The pharmerging markets will expand at a compound annual growth rate of 8-11% through 2018
• Total global spending will reach $1.3 trillion in 2018, an increase of $290-320 billion from 2013, driven by population growth, an aging population, and improved access in pharmerging markets.
• A compound annual growth rate of 4-7% on a constant currency basis, will be slightly higher than the 5.2% recorded over the past five years
Global Market Analysis for GCP:
"Good clinical practice", was developed under the auspices of the International Conference on the Harmonization of the Technical Requirements for the Registration of Human Pharmaceuticals (ICH process) and is applicable in the European Union, the United States and Japan.
The Global Clinical trial management system Market is expected to reach Significant Market Size by the end of the forecasted period and is expected to grow at a CAGR of ~15%.
IMS Market Prognosis 2012 predicted the pharma market in Asia (excluding Japan) to reach $350 billion by 2016 – $80 billion of this from China, but the majority from these other less talked about markets. This accounts for 30% of the $1.2 trillion that makes up the global pharma market. Each country’s government has recognized the opportunity this industry can bring to national development, and are therefore focused on supporting and investing in the sector.
Global Market Analysis for Regulatory Affairs:
Regulatory Affairs Department is the backbone of Pharmaceutical Industry. It is the revenue generator for pharmaceutical Industry. The Regulatory Affairs department is an important part of the pharmaceutical companies.
More than 15 years span is required to develop and launch a new pharmaceutical product in the market. The Regulatory Affairs Agencies explains expenditure spent on each drug annually is $850 million in US. The Indian Pharmaceutical industry is one of the fastest growing industries in India, with a compounded annual growth rate (CAGR) of over 13 % in last 5 years and it is expected to grow at a higher rate in coming 10 years where India spends around $300 million, united kingdom $700 , Brazil $200 million , France $550, Italy $400. As per cabinet decision in June 2010 Japan amended a new policy i.e., Health power strategy through “Life Innovation” with an expenditure spent on each drug was $450 million.
Internally it cooperates with other department like drug development, manufacturing, marketing and clinical research. Externally, it is the key interface between the company and the regulatory authorities. Industrialized regulatory affairs are to drive compliance, speed to market, and cost efficiency.
· Market revenue in terms of US$ Million for the period between 2013 and 2023 along with the compound annual growth rate (CAGR %) from 2015 to 2023 are provided for all the segments, considering 2014 as the base year.
· Product development, research, and commercialization units are being set up at an increased rate across emerging economies owing to cheap resources and raw material costs.
· The vast population base of Asia Pacific also makes it a lucrative regional market for the medical industry. These factors are acting in favor of the regulatory affairs outsourcing markets in these regions and will help strengthen the market’s foothold in the next few years.
· As a result, the market for regulatory affairs outsourcing market in emerging economies will offer the most lucrative and sustained growth opportunities for the global market.
· The market is expected to expand at a 15.8% CAGR in Asia Pacific and 11.1% CAGR across Latin America from 2015 to 2023.
· The global regulatory affairs outsourcing market is expected to reach USD 12.4 billion by 2025.