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genericdrugs 2020

About Conference


Our Organising Committee invites all the participants from all over the world to attend “Global Summit on Generic Drugs and Quality Control” slated on September 07-08, 2020 | Prague, Czech Republic which covers on all aspects of the pharmaceutical sciences, manufacturing, quality with strong emphasis on originality and scientific quality

Generic Drugs 2020 conveys recent developments in Generic drug marketing and production of generic drugs and contract manufacturing. A complete knowledge of a scientific discipline that described the effects of generic drug marketing will now explores the Scope of generic drug marketing in industry. Generic Drugs 2020 provides detailed market, technology, and industry analyses to help readers quantify and qualify the market for prescription generic drugs. Important trends are identified and sales forecasts by product categories and major country markets these are based on industry sources and considered assessment of the regulatory environment, healthcare policies, demographics, and other factors that directly affect the generic drug market. The wider economic environment is also taken into account.

The scope of Generic Drugs discusses the implications of all the above-mentioned trends, in the context of the current size and growth of the generics market, both in global terms and analysed by the most important national markets. The nature and structure of the generics industry is discussed, and an update on M&A activity. With first-generation biopharmaceutical products reaching the end of their patent lives, a whole new market field of bio generics or bio similar is opening up, for those generics companies capable of the technological expertise required. The international landscape is changing for generics as for all pharmaceuticals. China, India, Eastern European countries and Brazil are among rising centres of generic activity.

Scientific Sessions

 

Track-1: Generic Drugs

Generic drugs are replicas of brand-name drugs that have the same dosage, intended use, effects, side effects, route of administration, risks, safety, formulations, manufacturing, excipients color taste and strength as the original drug, and their pharmacological effects are exactly the same as those of their brand-name counterparts. Generic drugs sold without brand names are usually less expensive than branded drugs, even though they are chemically equal to branded drugs and meet the similar standards of the FDA for safety and purity.

 

Track-2: Quantitative Methods and Modeling to Facilitate Generic Drug Development

Modeling and Simulation have been more used in drug development. Model-informed drug development (MIDD) methods can be applied to both brand and generic drug products. MIDD comprises pharmacokinetic, pharmacodynamics models, absorption models, systems pharmacology, quantitative risk modeling, and emergent machine learning tools. Quantitative methods have been used to discuss critical scientific and regulatory issues in all phases of the product lifecycle, from pre-investigational new drug applications and post-approval evaluation of new and generic drugs.

 

Track-3: Usage and Acceptance of Generic Drugs

The major advantage of using generics is the price. Generics cost around 40 to 60 percent less, and you get the same formulation, dosage form and quality of medication. Hospitals and physicians prescribe generics more than brand-name of drugs. In fact, they make up more than 80 percent of prescriptions filled in the U.S. Thus the perspective of patients and medicine consumers of these medicines is an important factor to enhance the use and utilization of generic medicines.

 

Track-4: Biosimilars

A biosimilar is a biologic medical product that is an identical copy of an original product. Biosimilars are almost similar to licensed reference product not withstanding 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. Even though both biosimilars and generic drugs have the same commercial basis, they are two completely different products when it comes to their structure, development and authorization.

 

Track-5: Preformulation Studies

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-6: Concept of Bioequivalence

A generic drug has the same active ingredients, dosage form, strength, and route of administration. The FDA requires applicants of a generic drug to afford evidence that would help establish bioequivalence between their drug and the reference drug. The agency uses two parameters when evaluating bioequivalence one is the rate of absorption and the other is the extent of absorption. When a drug is administered, and serum concentrations are measured at several time points, the AUC can be calculated. The AUC represents the extent of absorption and is a cumulative measure of the drug’s concentration over time.

 

Track-7: Strategies for Promoting Generic Drug Utilization and Development

To facilitate generic drug development, two methods have been developed by researchers and policymakers those are implementing initiatives and offering aids or incentives for generic drug innovations. To approve the generic drug availability and to assist the generic pharmaceutical industry with identifying the most appropriate method for developing drugs and generating evidence needed to support ANDA approval, FDA regularly publishes product specific guidances on how to develop therapeutic equivalents to specific reference listed drugs.

 

Track-8: Challenges for Manufacturing of Generic Drugs

The main challenges for generic manufactures are strengthening the existing regulatory system especially for enabling more detailed and universal classification of drugs and chemicals between branded generic and generics. High R&D cost and investment in research is also a major stumbling block in this direction.

 

Track-9: GMP, GCP and Quality Control

Good manufacturing practice is a method that provides guidance for manufacturing, testing, and quality assurance to ensure that a manufactured product is safe for human consumption or use. Currently Good Manufacturing Practices is aimed primarily at managing and reducing the risks integral in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. FDA regulates the quality of pharmaceuticals very carefully. In Recent trends FDA is the main regulatory standard for ensuring pharmaceutical quality.

 

Track-10: Quality Control

Quality control (QC) is a method to set of quality criteria that meets the requirements of the customer. A major feature of quality control is the establishment of well-defined controls. The major role of Quality Impact Assessment measures 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. These controls help standardize both production and reactions to quality issues.

 

Track-11: Formulation Development

Formulation development performs a key function of product improvement which can determine patentability, lifecycle and, in the end, the fulfillment of a pharmaceutical product. Companies integrate method improvement features and personnel into their product improvement cycle in lots of one-of-a-kind methods. Optimization of existing formulations is needed to create new merchandise, Reduce costs, to capitalize on developments with greater profitability, novel formulations for stepped forward transport of existing dosage paperwork, to quick recalculate formulations based totally on defined standards, to create compliant merchandise quicker by the use of present tested formulas.

 

Track-12: Quality Assurance, Quality Control and Audit

Quality manipulate is a system meant to ensure that a synthetic product to a described set of quality criteria that meets the requirements of the purchaser or customer. A primary issue of great control is the status quo of well-defined controls. These controls assist standardize both production and reactions to best problems. The function of Quality Impact Assessment & effectiveness checking is a crucial operation of the pharmaceutical enterprise. To Perform Quality Control technique of project management numerous good manage equipment and software programs are required. Quality manipulate additionally performs a major role in analytical method improvement.

 

Track-13: Generics and Biosimilars Industry Strategy

The "Generic medication Market: 2015-2030 Opportunities, Challenges, methods & Forecasts" report presents Associate in Nursing in-depth assessment of the generic medication and Analysis of key therapeutic areas and leading generic medication pufecosystem together with technology, European Biosimilars Market social science, key trends, market drivers, challenges, investment potential, regulative landscape, leading therapies, Pharmaceutical trade opportunities, future road map, Following key trends, market drivers, challenges, Analysis of key therapeutic areas and leading generic trends ,value chain, scheme player profiles and methods and regulative landscape of world trends throughout the world Biosimilars medicines. The report presents market size forecasts for biosimilar exchangeability & generic medication from 2017 to 2030.

 

Track-14: Drug Discovery and Designing

Drug design, now and again referred to as rational drug design or actually rational layout, is the inventive method of locating new medicinal drugs based on the expertise of an organic goal. The drug is most usually a natural small molecule that activates or inhibits the characteristic of a biomolecule and biosimilar together with a protein, which in turn consequences in a healing benefit to the patient. In the most basic feel, Pharmaceutical drug design includes the Drug interactions of molecules which are complementary in form and charge to the bimolecular goal with which they have interaction and therefore will bind to it.

 

Track-15: Global Generic Trends

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-16: Global Generic Drug Market Strategy

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.

 

Track-17: New Approaches to Maximize Competition Generic Drugs

Building the market for usual medicines is a key method to containing drug prices within the US, one that USP actively supports via our requirements-setting work. That is why FDA Commissioner Scott Gottlieb’s management and the efforts of FDA team of workers to encourage established drug development and beautify its approval system.  Increased get right of entry to universal drug treatments will facilitate the availability of existence-saving treatment plans, whilst supporting to ensure low-cost and sustainable charges to patients and the healthcare machine, and upholding the FDA’s fashionable for proof-primarily based, technology-based totally regulation.

 

Track 18: Generic Drug Market

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.

 

 

 

Market Analysis

Around 70 per cent of market share (in terms of revenues), generic drugs form the largest segment of the Indian pharmaceutical sector. India exports 20% of global generic drugs market, (in terms of volumes) making the country the largest provider of generic medicines globally and is expected to expand further in coming years. The share of generic drugs is expected to growing domestic generic drug market is expected to reach US$ 27.9 billion in 2020. Due to their competition in generic drugs, growth in this market gives a great opportunity for Indian firms. Generic drug market is expected to grow in further coming few years, with many drugs going off-patent in the US and other countries.  India is a leading country in the world's generic drugs market, exporting US$17.3 billion worth of drugs in the 2017–18 year. India’s exports of generic drugs to the United States and the European Union. In most of the Countries the Launch of the Drug in  to the market under control of a National Drug Regulatory Authority(NDAI). It is the General procedure any pharmaceutical company. The Marketing Authorization will able to establish the quality, safety, efficacy of the Drug. Central Drug Standard Control organization also known as Drug Controller General of India is having the sole responsibility to give a Authorization to the new Drugs. A Generic Drug also needs to seek approval from Drug Controller General of India.

 

Scope and Importance:

After the expiry of patent or marketing rights of the patented drug, generic drugs are marketed. Generic drugs are available at affordable prices with maintaining quality. These ‘Generic formulations balance public interest as critical disease like cancer, AIDS etc. It is widely accepted both developed and developing countries. An estimated half of all prescriptions in the USA are now filed with approved generic drugs. In order to market drugs, U.S. generic manufacturers must have a permit and approval from the Food and Drug Administration (FDA) indicating that the active ingredient is approximately the same as that of the brand name. The determination of drug approval is made according to whether it is pharmaceutically equivalent, bio-available, and bioequivalent. World Health Organization (WHO) provided a definition for counterfeit drugs.

 

Societies Associated with Generic Pharma:

  • Canadian Generic Pharmaceutical Association (CGPA)
  • International Generic Pharmaceutical Alliance - IGPA
  • European Generic Medicines Association
  • Generic Pharmaceutical Association - FiercePharma
  • British Generic Manufacturers Association
  • Generic Pharmaceutical Association (GPhA)

 

European Associations:

  • European Association of Faculties of Pharmacy (EAFP)
  • European Association for Health Information and Libraries (EAHIL)
  • European Association of Hospital Pharmacists (EAHP)
  • European Biosafety Association (EBSA)
  • European Federation for Medicinal Chemistry (EFMC)
  • European Federation for Pharmaceutical Sciences (EUFEPS)
  • European Pharmaceutical Students Association (EPSA)
  • European Society of Clinical Pharmacy (ESCP)
  • European Society of Regulatory Affairs (ESRA)
  • Pharmaceutical Group of the European Union (PGEU)

 

Worldwide Associations and Society

  • Controlled Release Society (CRS)
  • Institute of Pharmacy Management International (IPMI)
  • International Academy of Compounding Pharmacists (IACP)
  • International Association for Pharmaceutical Technology (APV)
  • International Federation of Pharmaceutical Manufacturers Associations (IFPMA)
  • International Federation of Pharmaceutical Wholesalers (IFPW)
  • International Pharmaceutical Excipients Council (IPEC)
  • International Pharmaceutical Federation (FIP)
  • International Pharmaceutical Students Federation (IPSF)
  • International Society for Medical Publication Professionals (ISMPP)
  • International Society of Oncology Pharmacy Practitioners (ISOPP)
  • International Society for Pharmaceutical Engineering (ISPE)
  • International Society for Pharmacoepidemiology (ISPE)
  • International Society for the History of Pharmacy (ISHP)
  • International Society for the Study of Xenobiotic (ISSX)
  • International Society of Pharmaceutical Compounding (ISPhC)
  • International Young Pharmacists' Group (YPG)
  • Parenteral Drug Association (PDA)
  • Regulatory Affairs Professionals Society (RAPS)
  • Society for Bimolecular Sciences (SBA)
  • Society for Cell Science (SFCS)
  • Society for Translational Oncology (STO)

To Collaborate Scientific Professionals around the World

Conference Date September 07-08, 2020

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