Global Summit on Generic Drugs and Quality Control September 07-08, 2020 Prague, Czech Republic

Track 1:Best Practices & Strategies for Generic Drug Development 

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 2:Modernization of Bioequivalence Standards for Generic Products

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 3: Application of Quantitative systems pharmacology (QSP)

QSP is a quantitative platform that covers a broad-spectrum of tools, of which physiologically based models and quantitative clinical pharmacology (QCP) describes drug deposition and associated variability in human beings. In generic drugs, QP approaches integrate biological, physiological and drug properties to set up clinically relevant bioequivalence (BE). QCP approaches are essential to evaluate design and sensitivity to reduce cost and time of complex drug development.

Track 4: Bioequivalence approaches for complex injectable API and formulations

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 is confined to oral drugs and biologics mostly injectables, the reason for this is molecular complexity and manufacturing process

Track 5: Generic Animal Drug

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 6: Pharmaceutical Quality Assurance

The purpose of Quality Assurance 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 7: Challenges of Manufacturing Generic Drugs

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 8: Acceptance of Generic Drugs by People

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 9: Challenges of Marketing Generic Drugs

Although the faster approvals of generic product incouraging, 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 10: Biosimilars

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 11: Current Good manufacturing practices (CGMP)

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 12: Quality by Design (QbD) for generic drugs

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 13: Super Generic drugs and Bio Betters

In order to improve investment returns the pharmaceuticals have started focusing on re-innovating in the form of value-added generics (Super Generics) and value-added biologics (bio betters). The Re-innovated product offers advantages in terms of patient convenience by new route of delivery, dosage form, pharmacokinetic profile, stability, efficacy, safety, process of manufacturing.

Track 14: Patent Access& Intellectual property& FDA Regulations

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: Complex Generic Drug Product

According to the FDA 2016 generic drug user free 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.

Generic Drug Market by Brand (Branded Generic and Pure Generic) for Central Nervous System (CNS), Dermatology, Respiratory, Cardiovascular, Oncology, and Other Therapeutic Applications - Global Industry Perspective, According to the market analysis report, the International Generic Drug market estimated to be across 200.20 Billion USD in 2015 and is expected to reach approximately USD 380.60 billion by 2021, growing at a CAGR of about 10.8 % from 2016 and 2021.

It is driven by the factors such as cost-effectiveness and135 billion worth patented drugs expiry and Government initiatives has given it a competitive lead over the branded drugs in the market, Nearly $150 Billion USD worth drug patents are about to expire in 2020 which can drive Generic drug market into profits.

North America is beholder of the largest share in the generic drug market, In US 89% of the prescribed drugs are Generic and the demand is high for generic drugs, In the Asia pacific region India and China dominated the Generic drug market in volume, total Indian generic drugs market was around 21billion USD in the year 2015 mainly due the Indian companies getting international regulatory approvals like U.S FDA, MHRA.UK, TGA Australia and MCC South Africa. Brazil was the largest Generic market in Latin America it is due to the sale of Generic medicine was accounted for 23% and will remain to be dominant in forecast period due to high demand and increasing development in the pharma sector. Europe is observed to show significant growth in Generic drug market as result of prevalence of chronic diseases and government support.

With members from around the world focused on learning about Generic Drugs and Quality Control; this is your best opportunity to reach the largest assemblage of participants from the Generic Drugs Community. Conduct presentations, distribute information, meet with current and potential scientists, make a splash with new Techniques in Generic Drugs and Quality Control, and receive name recognition at this 2-day event.

Important Dates & Links

Abstract Submission:

1st Deadline: February 19, 2020

2nd Deadline: April 22, 2020

3rd Deadline: June 24, 2020

For online Abstract Submission, PS: Generic Drugs2020 Abstract

Registration:

1st Early Bird: Feb 29, 2020

2nd Early Bird: March 28, 2020

Final Date: September 20, 2020

For online Registration, PS: Generic Drugs2020 Registration

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