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2nd International Conference on Generic Drugs and Biosimilars, will be organized around the theme “Merger and Acquistion Scenerio in Pharmaceutical Industry”

Generics-Biosimilars 2017 is comprised of keynote and speakers sessions on latest cutting edge research designed to offer comprehensive global discussions that address current issues in Generics-Biosimilars 2017

Submit your abstract to any of the mentioned tracks.

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A nonexclusive medication (nonspecific medications, short: generics prescriptions) is a medication characterized as "a medication item that is tantamount to a brand/reference recorded medication item in measurements frame, quality, quality and execution attributes, and planned utilize." It has likewise been characterized as a term alluding to any medications showcased under its concoction name without publicizing or to the compound cosmetics of a generic medication as opposed to the promoted mark name under which the medication is sold. Despite the fact that they may not be connected with a specific organization, nonspecific medications are liable to the directions of the administrations of nations where they are apportioned. Worldwide nonspecific is marked with the name of the maker and the received name (non-restrictive name) of the medication. A nonspecific medication and OTC Drugs must contain indistinguishable dynamic fixings from the first definition.

  • Track 1-1Generic drug manufacturing
  • Track 1-2 Generic drugs Europe
A nonexclusive pharmaceutical  is a medication that is precisely the same as the brand-name tranquilizes, however must be delivered after the brand-name medication's patent has terminated. A Generic   medication  and OTC Medications is the same as a brand-name tranquilize in:
  • measurement
  • wellbeing 
  • quality
  • the way it works
  • the way it is taken
  • the way it ought to be utilized
A medication organization grows new medications and pharmaceutical as brand-name tranquilizes under patent assurance where there is not a single prescription mistake are in sight. This thus secures the interest in the medication's advancement by giving the medication organization the sole appropriate to make and offer the brand-name sedate while the patent is essentially.
  • Track 2-1OGD and OPQ review
  • Track 2-2OPQ update
  • Track 2-3OGD update

Biosimilars the Generic form of organic is the new popular expression in pharmaceutical industry. Biosimilars are exceptionally like authorized reference item not withstanding minor contrasts in clinically idle parts; additionally there are no clinically significant contrasts between the organic and the reference item as far as wellbeing, virtue, and strength. This track incorporates: Licensing of Biosimilars, Biomarkers direction, Patent issues, BLA petitioning for Biosimilars, Regulatory prospects of BRIC nations, a worldview of customary generics to Biosimilars, Biologics& Bio waiver endorsement for Biosimilars and different parts of Biosimilar endorsements.

  • Track 3-1Bio-analytics for Biosimilars
  • Track 3-2Extrapolation and Interchangeability
  • Track 3-3Legal Considerations for Biosimilars
  • Track 3-4Biosimilar Uptake and Market Considerations
  • Track 3-5Challenges and regulatory approach for biosimilars
  • Track 3-6Future of next generation biosimilars

Pharmacology is the branch of solution and science worried with the investigation of medication action where a medication can be comprehensively characterized as any man-made, characteristic, or endogenous (from inside body) particle which applies a biochemical and additionally physiological impact on the cell, tissue, organ, or living being (once in a while the word pharmacon is utilized as a term to envelop these endogenous and exogenous bioactive species). Sedate improvement is the way toward conveying another pharmaceutical medication to the market once a lead compound has been distinguished through the procedure of medication revelation. It incorporates pre-clinical research on microorganisms and creatures, petitioning for administrative status, for example, by means of the United States Food and Drug Administration for an investigational new generic medication to start clinical trials on people, and may incorporate the progression of acquiring administrative endorsement with another medication application to showcase the medications and Increase Global  Pharma Market

  • Track 4-1Clinical pharmacology and Drug addictions
  • Track 4-2Characterization of biologically active compounds
  • Track 4-3Recent advancements in research and developments
  • Track 4-4Recent advances in computer aided drug design
  • Track 4-5Novel Approaches in drug discovery

A clinical trial is an examination study that tests another restorative treatment or another method for utilizing a current treatment to check whether it will be a superior approach to counteract and screen for analyse or treat a disease1. For any new medication to enter in clinical trial, it must pass preclinical studies. Preclinical studies  of Biosimilars include in vitro (i.e. test-tube or Laboratory) studies and trials on creature populaces. Extensive variety of measurements of the study medication is given to creature subjects or to an in-vitro substrate with a specific end goal to acquire preparatory adequacy, poisonous quality and pharmacokinetic data and includes Preclinical Studies in Phase I-IV.

  • Track 5-1Preclinical and Clinical Development
  • Track 5-2Optimising biosimilar clinical trial design
  • Track 5-3Biosimilars development and impact on clinical practice
  • Track 5-4Non-Clinical Studies in biosimilars development

Good Manufacturing Practice is that part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to 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 . Fact about Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. FDA regulates the quality of pharmaceuticals very carefully. Current Trends in the FDA is the main regulatory standard for ensuring pharmaceutical quality, Patent AccessIntellectual property & FDA Regulations.

  • Track 6-1Facts About Current Good Manufacturing Practices (cGMPs)
  • Track 6-2Current GMP guidelines
  • Track 6-3Good clinical practices & Good Laboratory Practices
  • Track 6-4Current regulations and quality Standards
  • Track 6-5International Regulatory Affairs

A patent is an arrangement of select rights conceded by a sovereign state to an innovator or appointee for a constrained timeframe in return for point by point open divulgence of a creation. An innovation is an answer for a particular mechanical issue and is an item or a procedure. Licenses are a type of protected innovation. Regulatory affairs  is a comparatively new profession which developed from the desire of governments to protect public health by controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics and complementary medicines. Regulatory Affairs  is involved in the development of new medicinal products from early on, by integrating regulatory principles and by preparing and submitting the relevant regulatory dossiers to health authorities.

  • Track 7-1Lifecycle management of drug products
  • Track 7-2Patents and disputes case studies
  • Track 7-3Identification techniques adulterated and misbranded drugs
  • Track 7-4FDCA (Federal Food, Drug, and Cosmetic Act )
  • Track 7-5Exemption in prescription and OTC drugs
  • Track 7-6Environmental health hazards

Quality control, or QC for short, is a procedure by which elements audit the nature of all variables required underway. ISO 9000 characterizes quality control as "A piece of value administration concentrated on satisfying quality requirements, Quality control underscores testing of items to reveal deformities and answering to administration who settle on the choice to permit or deny item discharge, though quality affirmation endeavours to enhance and balance out creation (and related procedures) to maintain a strategic distance from, or possibly minimize, issues which prompted to the defect(s) in the principal place.[citation needed] For contract work, especially work granted by government organizations, Pharmaceutical Industry quality control issues are among the top purposes behind not recharging an agreement manufacturing, Other elements have added to the feeling that the pharmaceutical business imaginative execution has declined. Over the previous decade, a developing offer of the business' R&D yield has comprised of incremental enhancements to existing generic medications  instead of new sub-atomic substances. Execution measures that consider just altogether new medications, for example, the quantity of NME endorsements every year—miss that move and underestimate the business' R&D Field

  • Track 8-1New Product Development
  • Track 8-2Patent innovations
  • Track 8-3The Global R & D and Regulatory Landscape
  • Track 8-4 Regulatory landscape of generic drugs throughout the globe

Pharma Pricing & Market Access general change in Pharma Industry   in connection to payers is the move from volume to esteem. In estimating terms, this is a move from a compensation for-pill to a compensation for-execution show. Basically, instalment will be allowed to items that exhibit esteem as far as enhanced wellbeing results or brought down social insurance cost Generic Medication and in addition that perform superior to less productive and less compelling contenders. Specialists bring up that numerous healing facility methodologies are as of now measured on execution, thus the same ought not to out of the ordinary with pharmaceutical items

  • Track 9-1Generic Market and Business Opportunities
  • Track 9-2Analysis of key therapeutic areas and leading generic drugs
  • Track 9-3Regulatory landscape of generic drugs throughout the globe
  • Track 9-4Market forecasts are provided for sub markets and their subcategories

Health economics is a branch of Pharmacoeconomics concerned issues identified with productivity, viability, Quality  esteem and conduct in the generation and utilization of wellbeing and social insurance. In expansive terms, wellbeing financial analysts concentrate on the working of medicinal services frameworks and wellbeing influencing practices, for example, smoking and so on and a huge concentration of wellbeing financial aspects of Pharmaceutical Industry and  microeconomic assessment of the estimation of individual medications & Global Pharma Market . The states in Europe evaluate certain new and existing pharmaceuticals and gadgets utilizing financial assessments by wellbeing innovation by health technology assessments

  • Track 10-1Lifecycle management of drug products
  • Track 10-2Patents and disputes case studies
  • Track 10-3INDA Rules and Regulations
  • Track 10-4Cost-minimization analysis

The "Generic Drugs Market: 2015 - 2030 - Opportunities, Challenges, Strategies & Forecasts" report presents an in-depth assessment of the generic drugs and Analysis of key therapeutic areas and leading generic drugs  pufecosystem including technology, economics, key trends, market drivers, challenges, investment potential, regulatory landscape, leading therapies, Pharmaceutical Industry  opportunities, future road map, Following key trends, market drivers, challenges, Analysis of key therapeutic areas and leading generic trends ,value chain, ecosystem player profiles and strategies and  Regulatory landscape of global trends  throughout the globe The report also presents market size forecasts for generic drugs from 2017 through to 2030. The forecasts are segmented for over 10 therapeutic areas, 3 brand classifications, 5 regions and 25 leading countries.

  • Track 11-1Major market trends & Featured regional market trends
  • Track 11-2Clinical development strategies for biosimilars
  • Track 11-3Advances in Biosimilar Production & Technologies
  • Track 11-4Scale Up of Biosimilars
  • Track 11-5Business Development in biosimilar
A nonexclusive pharmaceutical  is a medication that is precisely the same as the brand-name tranquilizes, however must be delivered after the brand-name medication's patent has terminated. A Generic   medication and OTC Medications is the same as a brand-name tranquilize in:
  • measurement
  • wellbeing 
  • quality
  • the way it works
  • the way it is taken
  • the way it ought to be utilized
A medication organization grows new medications and pharmaceutical as brand-name tranquilizes under patent assurance where there is not a single prescription mistake are in sight. This thus secures the interest in the medication's advancement by giving the medication organization the sole appropriate to make and offer the brand-name sedate while the patent is essentially
  • Track 12-1Pharmacokinetic and pharmacodynamics properties of generic drugs
  • Track 12-2Implementation of TRIPS in developing countries
  • Track 12-3Trends for investing in biopharma manufacturing
  • Track 12-4Market size forecasts for generic drug

Biosimilars are interlinked with FDA activities that have as of now been declared to incorporate upgraded following and follow-up of post market issues, arranged changes in AERS, and pilots of new post advertise medicate observing systems. Current difficulties in pharmacovigilance, adverse medication responses with pharmaceutical items, Biosimilar rules for Pharmacovigilance practice and pharmacoepidemiology are the focuses that should be laid accentuation in this session.

  • Track 13-1Improve Pharmacovigilance through Patient and Provider Education
  • Track 13-2Regulatory updates and key drivers for registration approvals in US, EU and China
  • Track 13-3Regulatory requirement for biosimilar IND filing in the US

Biosimilars are surmounting pharmaceutical business division from most recent three decades and deals appear to extend coherently. Advances in the biotechnology prompt to change and exposure of new natural items (biosimilars) to treat diverse life-debilitating illnesses. Biosimilars are organic medications that are conveyed after expiry of the patent of affirmed pioneer and include Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics through Abbreviated New Drug Applications (ANDAs).

  • Track 14-1Overview of the current and emerging local trends
  • Track 14-2Key changes in the pipeline of biopharma products
  • Track 14-3Highlighting opportunities and challenges in Biomanufacturing

Biosimilar engineers and their outsourcing accomplices must know about the picked nation's administrative scene, and have broad information of any current biosimilar endorsement pathway and the most recent administrative organization rules. Furnishing administrative experts with endorsements of investigation (CoA) for a U.S.- advertised comparator could challenge. As opposed to European practice, U.S. makers tend not to make CoAs accessible to parties required in the production network or bolster the improvement of a contender by discharging CoAs for clumps acquired for clinical trials. Giving family proclamations to the reference item more often than not is acknowledged as an option.

  • Track 15-1 Product Similarity for Biosimilars & Analytical Challenges
  • Track 15-2Role of Medical Affairs in Biosimilars
  • Track 15-3Regulatory strategy for generics and biosimilars

Biotherapeutics more often than not alludes to helpful materials created utilizing organic means, including recombinant DNA innovation. Biotherapeutics are fundamentally operators, used to treat and maintain a strategic distance from human malady by interrelating with the microbial environment of the host. Biotherapeutics can target particular particles inside the human body, and have a decent reputation with patient wellbeing. Fabricating biotherapeutics is mind boggling, as they are bigger mixes in both size and structure, and can be touchy to ecological conditions.

  • Track 16-1Advancements in Biotherapeutics
  • Track 16-2 Biotech and Biosimilar Products
  • Track 16-3Antibody based therapeutics
  • Track 16-4Therapeutic Antibodies and Fc Fusion Proteins

Biosimilars are surmounting pharmaceutical business division from most recent three decades and deals appear to extend coherently. Advances in the biotechnology prompt to change and exposure of new natural items (biosimilars) to treat diverse life-debilitating illnesses. Biosimilars are organic medications that are conveyed after expiry of the patent of affirmed pioneer and include Hatch-Waxman act is the amendment to Federal, Food, Drug and Cosmetics act which established the modern system of approval of generics through Abbreviated New Drug Applications (ANDAs).

  • Track 17-1Key Aspects in Technical Development
  • Track 17-2Analysis of the Biosimilar Development Pipeline
  • Track 17-3Legal Issues and Implementation of the BPCI Act

Biosimilar engineers and their outsourcing accomplices must know about the picked nation's administrative scene, and have broad information of any current biosimilar endorsement pathway and the most recent administrative organization rules. Furnishing administrative experts with endorsements of investigation (CoA) for a U.S.- advertised comparator could challenge. As opposed to European practice, U.S. makers tend not to make CoAs accessible to parties required in the production network or bolster the improvement of a contender by discharging CoAs for clumps acquired for clinical trials. Giving family proclamations to the reference item more often than not is acknowledged as an option.

  • Track 18-1Case studies of biosimilar approvals/rejections
  • Track 18-2Challenges in clinical development
  • Track 18-3Analytical Development and Quality Control

Biologic restorative items created through rDNA innovation as recombinant protein-based solutions that have been in clinical use since the mid-1980s as unique biopharmaceuticals have extraordinarily added to the treatment of extreme metabolic and degenerative infections. The late close of the information assurance or licenses for the greater part of them made open doors for the advancement of duplicate adaptations of unique biopharmaceuticals with comparative biologic movement (named biosimilars). Generation of these new items is relied upon to take care of overall demand, advance market rivalry, keep up the impetuses for development, and maintain the human services frameworks.

  • Track 19-1Analysis of the Biosimilar Development Pipeline
  • Track 19-2Physicochemical Biosimilar Comparability Studies
  • Track 19-3Biosuperior Development Strategies

With an expected $67 billion worth of licenses on organic items lapsing before 2020 and governments forced to diminish quickly rising human services costs, biosimilars speak to a noteworthy open door for the pharmaceutical business. Biosimilars are exceptionally like their authorized reference item not withstanding minor contrasts as excipients in the plan; likewise there are no wonderful contrasts between the biologicals and the reference item as far as wellbeing, immaculateness, and strength. However, until a global development strategy is adopted, regulatory, therapeutic and legal challenges remain.

  • Track 20-1 Impact of FDA Guidance on Substitution Policies
  • Track 20-2Chronicles of a Biosimilar Production Facility 
  • Track 20-3challenges in developing monoclonal biosimilars
  • Track 20-4 Impact of FDA Guidance on Substitution Policies
  • Track 20-5Chronicles of a Biosimilar Production Facility 
  • Track 20-6challenges in developing monoclonal biosimilars

A biosimilar is an organic item very like an affirmed natural item, known as a kind of perspective item, with no clinically significant contrasts as far as wellbeing and viability. In the U.S., if a natural compound exhibits practically identical information to a U.S. Nourishment and Drug Administration (FDA)- authorized item from expository, preclinical and clinical reviews, it will be acknowledged as a biosimilar after termination of trend-setter licenses through a curtailed course. Tradable natural items are likewise biosimilars, however should meet extra criteria to coordinate the reference item. Interchangeable can be substituted for the reference item without a medicine from a social insurance supplier.

  • Track 21-1Biosimilar Product Reimbursement and Pricing
  • Track 21-2Biosimilar Regulatory Updates and Legal Implications
  • Track 21-3Biosimilar Market Access and Commercialization