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Global Summit on Generic Drugs and Quality Control, will be organized around the theme “Current and Future Global Drug Market Trends and Manufacturing”
Generic Drugs 2020 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Generic Drugs 2020
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Spurring innovation is required for development in generics field, advanced scientific methods, quality data and the use of sophisticated quantitative methods and computational methods are to be implemented, A specific category of drugs that are at times been difficult to make equivalent generics(complex generics) represent some very expensive drugs and are widely used generics, the products with complex active ingredients such as peptides, polymeric compounds, complex mixtures of Active pharmaceutical ingredients(API) Complex formulations such as liposomes, colloids etc. Drugs with complex route of delivery such as topical drugs and ophthalmological products that are often formulated as suspensions.
- Track 1-1Mechanism-informed modelling
- Track 1-2Modelling and simulation
- Track 1-3complex drug-device combination products e.g.; auto-injectors, metered dose inhalers
- Track 1-4Complex drug-device combination products – orally-inhaled and nasal drug products
- Track 1-5Quantitative methods and modeling-informed regulatory decision making
Bioequivalence (BE)/ bioavailability(BA) studies play a major role in drug development both for new drug and their generic equivalents, these studies are also done before the approval of drug (post approval period) and are expressed in systemic exposure measures, such as Area under plasma Concentration-Time curve(AUC) and maximum concentration C-max these measures are assumed to relate with safety and efficacy out comes that may expressed by biomarkers. This (BA), (BE) studies provide important information in overall set of data that ensures the safety and effectiveness to the practitioners and patients.
- Track 2-1Research Activities
- Track 2-2Scientific Advances
Preformulation studies mainly focus on the concepts of physicochemical properties of drug. These properties not only affect their therapeutic efficacy but also the growth process of their specific dosage form. The Preformulation studies investigations confirm that there are no significant barriers to the compound’s development as a Marketed Drug or Generic drug. Preformulation Studies specifies the physical, chemical and mechanical properties of a new drug substance, in order to develop stable, safe and effective dosage form.
- Track 3-1sophisticated quantitative methods and computational modeling in drug development
- Track 3-2Quantitative methods and modeling (QMM)
- Track 3-3Quantitative Clinical Pharmacology (QCP) in generic drug development
- Track 3-4A network pharmacology-based approach to analysis
Some chronic disorders require long term supervision and expensive medical care,Though repeated drug administration can help managing such conditions relapses and require re-hospitalization, this condition remains a challenging situation for both practitioners and patients, for this type of conditions long acting injectables which provide sustained release of drug are suggested.
Mostly the concept of generics in confined to oral drugs and biologics mostly injectables, the reason for this is molecular complexity and manufacturing process.
- Track 4-1Mass spectrometry in evaluation of generics
- Track 4-2Bioequivalence of Endogenous Substances
- Track 4-3In vitro Bioequivalence
- Track 4-4Mass spectrometry in evaluation of generics
- Track 4-5Polymeric long acting injectables
- Track 4-6FDA approved biocompatible polymers
In the veterinary pharmaceutical market, the rise in the generic drugs for animal health care is the latest trend, the economic benefit of generic drugs is enabling the pet lovers to take care of their pets more efficiently.in the recent years FDA is approving the many number of generic drugs for the cats and dogs which has led to the adoption of generic drugs by the veterinarians, it is estimated that about 80% of the veterinarians are prescribing the generic drugs to save the pet owners money. However, the lower margin of profit given by the generic drugs compared to the branded drugs needs to be looked in by the veterinary practitioners.
- Track 5-1Current market situation and recent developments
- Track 5-2Advantages and disadvantages
- Track 5-3Existing regulatory policies
- Track 5-4History and feedback from professionals
The purpose of QA is to assure that medicine reaching every consumer or patient is safe, effective, and meets quality standards. A comprehensive quality assurance program includes both technical and managerial activities, many areas within a health care system are involved with quality assurance, including procurement, pharmacy, medical, nursing departments, as well as drug therapeutics committee by obtaining quality products which are safe and effective through structured selection and procurement methods, maintaining quality of products through the appropriate storage, monitoring and distribution and prescribing methods.
- Track 6-1Quality assurance
- Track 6-2Quality accessing
- Track 6-3Gmp
- Track 6-4Certification
- Track 6-5Appropriate storage
It’s clear that generic drugs manufacturers of have great chances of succeeding, but their journey comes with several challenges such as bringing product into the market as fast as possible, providing cost effective drugs while being profitable, marketing the product.
Once the branded drug goes off patient, the generic manufacturers go for a race to claim their share of the market, those first out in the market will get the highest attention.so this market players are looking for new versions of generic drugs by adding the value to the existing product rather than investing huge money for research and development of new drug.
- Track 7-1Discussion on super generics
- Track 7-2Abbreviated new drug application (ANDA)
- Track 7-3Patent term and approval of generic drugs
- Track 7-4Production and marketing
- Track 7-5To achieve the proposed revenue
Global health care expenditure is growing steadily and use of generic medicine is encouraged as cost cutting measure by many countries and their governments, as generic medicines are generally low expensive than their proprietary counterparts due to many reasons which include skipping necessity to research and development cost, less market competition.
But there are increased discussions in people with perceived doubts regarding the quality and equivalence of generic drugs, while there have been many reviews that have reported the views individually from professionals but not even a single review critically evaluating and appraising.
- Track 8-1optimal dosage form
- Track 8-2pharmaceutical formulation development
- Track 8-3Awareness
- Track 8-4past experience with medications
Although the faster approvals of generic product is encouraging, there are still many challenges to bring new economic and affordable product into the market that enables manufactures to make some profits and stay afloat as the cost of making generic drugs is same as branded drugs, yet branded drugs enjoy the greater profits because of patent protection.
It is also a challenge for health care personnel as there will be existence of several generic alternatives to a branded drug. To switch from a renowned branded drug to generic drug will be a challenging task for a chronic patient and polypharmacy users and elderly people who can easily be confused, especially due to the difference in morphology.
- Track 9-1Opportunities and challenges
- Track 9-2Regulations needed to balance the competitive marketplace
- Track 9-3Bringing affordable Generic to market
- Track 9-4Quality control and bioavailability
A biosimilar is a biologic medical product that is an identical copy of an original product. Biosimilars are practically identical to licensed original reference product with minor differences in clinically inactive components; also, there are no clinically meaningful differences between the biological and the reference product in terms of safety, purity, and potency. Although both generic drugs and biosimilars have related commercial basis, they are two completely different products when it comes to their structure, development and authorization. Biosimilars are becoming an increasingly significant in the field of pharmaceuticals industry worldwide, the challenges to develop and demonstrate biosimilars should overcome the inherent differences in the bioprocess manufacturing and biological, physiochemical characterization of a biosimilar compared with several different reference products. The technological difficulties to make copy of products while concentrating on regulatory and market demands is required to help innovation in the direction of attaining productive manufacturing process.
- Track 10-1Biosimilars in Therapeutics
- Track 10-2Biosimilars Development
- Track 10-3Biosimilars Pipeline
- Track 10-4Clinical Trials of Biosimilars
- Track 10-5leading generic trends
- Track 10-6Analysis of key therapeutic areas
Good Manufacturing Practice is the role in quality management that ensures the products are reliably produced and controlled according to the quality standards and appropriate to their intended use as mandated by the marketing authorization, product specification or clinical trial authorization. GMP aims at both Quality Control and production. (cGMP) Current Good Manufacturing Practices is aimed predominantly at managing and minimizing the risks in pharmaceutical manufacturing to ensure the quality, efficacy of products and safety. FDA, TGA, ANVISA, CDSCO, CFDA, MHRA, MFDS, MCC, NAFDAC, EMCDDA are the Regulatory body’s that control the quality of pharmaceuticals very carefully.
- Track 11-1Importance of CGMP
- Track 11-2CGMP regulations
- Track 11-3Principles of quality management
It is a systemic approach for ensuring quality of pharmaceuticals with predefined objectives. The focus of this concept is that quality should be built into product with understanding of the product and the process by which its manufactured along with knowledge of risk involved in manufacturing it and how severe those risks can be, while quality by design (Qbd) have been used to advance product and process quality in industry, this has been adapted by the Us Food And Drug Administration.
- Track 12-1New risk-based pharmaceutical quality assessment system (PQAS)
- Track 12-2Question-based Review (QbR) for generics
- Track 12-3ICH activities- ICH Q8, Q9 and Q10, Q11, Q12, Q13, Q2(R2)/Q14
- Track 12-4CPPs: Critical Process Parameters
The global pharma marketplace is experiencing essential auxiliary modifications with essential ramifications for India and Indian groups. North America continues on being the most important Pharma Market promotes it on earth including to about 33% of the $1 trillion in every year worldwide pharma deals in esteem phrases. Be that as it may, with the quick pace of improvement in Pharma Industry offers in Asia within the direction of the maximum latest five years and the European Biosimilars Market everyday development in the medium-term destiny, the focus of gravity for the pharma market is step by step shifting towards biosimilar manufacturers Europe is probably going to soon surpass North America as some distance as fashionable pharma offers. This is a pattern that might be going to proceed for year’s Biosimilars interchangeability to return because of expansive macroeconomic drivers, as an example, population and profits development biosimilar drugs. Beyond any doubt Japan and China accepted biosimilars will maintain on dominating pharma offers in Asia. For instance, with yearly pharma gives of over $eighty billion, China is as of now more than 5 times the extent of the Indian local pharma show off concerning esteem. Be that as it could, short every year marketplace profits development quotes of extra than 10-12 for each penny in countries, for example, India are likely going to peer an extending enthusiasm by global Pharma Industy corporations in different European Pharma markets such as from all global Pharmaceutical Industry.
- Track 13-1Growth in Biosimilars
The global generic drugs market reached value of US$340 Billion in 2018, registering a CAGR of 6.6% during 2011-2018. A generic drug is a medicine that contains the similar active ingredient and has an bioequivalent therapeutic effects like original drug. It is also identical in case of safety, quality, dosage, strength, route of intake, usage, effects, form, quality and side effects. These drugs can be produced only after the patent expiration of the brand-name drug. As compared to branded drugs, the production of generics cheaper as it does not require the repeated clinical (human) and animal studies to understand the effectiveness and safety of the medicine. The Global market for generic drugs should reach the target value $533 billion by 2021 from $352 billion in 2016 at a compound annual growth rate (CAGR) of 8.7%, from 2016 to 2021. Global drug markets for generic drugs, includes such as antibacterial, antidepressants, anticancer agents, anti-arthritics, cardiovascular drugs, Drugs for respiratory conditions, including asthma and COPD.
Intellectual property has different forms in case of access to medicine, patent is an public policy, where government aims to provide monopoly to a company in the market as an compensation for Research and development and also providing benefits to public in from of technological advancements, extensive patent protection delays and controls the competition in generic drug market ,patent expiry dates are critical for the timing of generic entry into the market.
- Track 15-1Formulation patent.
- Track 15-2Patents on manufacturing processes
- Track 15-3Patents on different crystal forms
- Track 15-4Patents on combination products
- Track 15-5Investigational New Drug (IND)
- Track 15-6New Drug Application (NDA)
- Track 15-7Abbreviated New Drug Application (ANDA)
- Track 15-8Over-the-Counter Drugs (OTC)
- Track 15-9Patents and disputes case studies
- Track 15-10Identification techniques adulterated and misbranded drug
According to the FDA 2016 generic drug user fee amendment, a complex generic drug is a product that that has, complex active ingredients e.g. (peptides polymeric compounds, complex mixtures of active pharmaceutical ingredient, naturally sourced ingredients) or a complex formulation such as (liposomes, colloids). drugs with the complex route of administration tropical drugs such as dermatological drugs, pomological drugs which are basically formulate as suspensions or emulsions, and complex dosage form (e.g. long acting injectables, metered-dose inhalers, transdermal) drug device combinations and drugs whose complexity concerning approval pathway.
- Track 16-1complex active ingredient
- Track 16-2complex dosage form
- Track 16-3complex route of delivery
- Track 16-4Complex drug-device combination
A generic drug is a pharmaceutical product, usually intended to be interchangeable with an innovator product that is manufactured without a license from the innovator company and marketed after the expiry date of the patent or other exclusive rights. Already prevalent in the U.S., Europe and much of the developing world, generic drugs are now finding their way into previously untapped markets such as Japan, largely driven by regulatory efforts to reduce healthcare costs. Generic drugs will account for nearly $350 Billion in revenue by the end of 2015. The market is further expected to grow at a CAGR of 12% over the next 5 years. As the market consolidates; larger players continue to grow their market share on the heels of acquisitions and mergers. Well established players are particularly keen to capitalize on joint ventures in untapped markets such as Japan.