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Pharma Biosimilars 2019

Sessions

Track 1: Analytical Strategies of Biosimilar

Biologics and Biosimilar analysis make the one of the most important aspect on the development on biological products. The use of production technologies such as disposable and supply chain logistics can help companies such establish flexibility facility involved in biosimilar analytical methods.

Bioanalytical methods include in all global events of biosimilars for example: GMP protein analysis, pre-clinical and clinical program, Bioassay for comparability and potency testing.

Track 2: Emerging Biosimilars In Therapeutics

In the field of biologics, the new avenue has created towards clinicians because explorations have created for better disease management. In the treatment of ailments like psoriasis, rheumatic arthritis, certain cancer inflammation, bowel diseases etc. showed some good outcomes because of using biologics. Biosimilar insulins which are newly formed are likely to enter the insulin landscape as patents for major branded insulin products ready to expire in the next few years. The emerging biosimilar like filgrastim, peg filgrastim, recombinant blood products, therapeutic products vaccine biosimilar, anti-bodies growth hormones, biosimilar peptide, all these are used to sound knowledge on biosimilars development on drugs.

Track 3: Current Challenges in Developing Biosimilars

For the development of biological calls many changes may occur. Concepts of biologics with considerations at initial stages, clinical developments are essential at early. For the successful development of biologics follow on proper scientific and strategic approaches are need. Most probably, the drug safety factors and labelling requirements are the overcoming challenges and important in continue of late clinical steps. And now it is much required to develop a drug product in according to quality by design.

Track 4: Regulatory Approaches of Biosimilars

biosimilars is likewise called as nonspecific adaptation of biosimilars. The clinically idle compound is not withstanding with biosimilars but rather minor contrasts and profoundly like authorized item; additionally, there Presently a-days in pharmaceutical industry biosimilars is shaped has another buzz. Furthermore, these are no clinically important contrasts between the biologicals and the reference item as far as intensity, wellbeing and immaculateness.  The worldview of customary generics to biosimilars, and different parts of Biosimilar endorsements. Also, these Biosimilars 2019 will give a phenomenal and overall chance to the researchers, accomplices and pharma pioneers from Biopharmaceutical and Biotechnology businesses to improve and to investigate the key market for Biosimilars and Biologics with an unmistakable photo of the administrative approach for biosimilars and biologics. The US biosimilars, European biosimilars, Canada biosimilars, UK biosimilars take a noteworthy part in cross the globe by 2019. Biosimilars development. And these biosimilar conferences will mainly focus on bio similar product development to deliver safe and successfully.

Track 5: Pharmacovigilance challenges in Biosimilars

Same proportion pharmacovigilance for biosimilars has comparatively more different from other products. Biosimilars 2019 session mainly look that have already been announced to include enhanced tracking and follow-up of post marketing surveillance issues, and on FDA initiative planned different changes in AERS, pilots of new developed post market strategies of drug-monitoring and ADR related problems. The guidelines of biosimilars for pharmacovigilance and pharma epidemiology are the points that shall be laid emphasis in the session In USA average annual income mostly spend on biologics comparing to generic drugs for example:16% on biologics and 3% on other drugs.

Track 6: BCS and IVIVC Based on Biosimilars

 These Mainly discusses about different types of drugs and adsorption distribution metabolism excretion pathways. And This biosimilars includes, In vitro diffusion cells for dissolution testing in formulation development, The preclinical testing of ADME in INVITRO. The primary moto of this work was to suggest the biosimilars potential of biopharmaceutical classification system which are known to increase the dissolution. These insoluble drugs which is orally absorbed. These Aims at addressing all such challenges of the pharma formulation sector at biologics and biosimilars at 2019 conference. The solubility includes in biopharmaceutical classification.

Track 7: Globalization of Bio Similar

These tracks mainly deal with biosimilar meetings those who can attend by following biologics/protein/biosimilar product process science, New biosimilar development, portfolio Management, Reasearch&development, biosimilar market, business operations, scientific affairs. This track mainly discusses about Risk-sharing arrangement LATAM market for bio-similar adopting innovative mechanism for generic drugs impact on global bio similar market and cost and riskmanagement.

Track 8: Clinical Development of Biosimilars

Risk Management, quality affairs, Case studies, clinical models, Transgenic animals Targeted cell-line development, clinical biosimilar tracks are major diseases of clinical trials. The pkd/docx studies toxicological studies and Aspects of genotoxicity tests. And These tracks are designed especially for those who are having more knowledge on clinical studies and clinicians’ prospects for biosimilars. These guidelines on the above-mentioned topics are also to be thrown effect upon at this biosimilars conference

Track 9: Bioequivalence assessment

The active ingredient from the pharma product and its absorption into the systemic circulation is mainly focus on equivalence release. Bioequivalence assessment includes strategies of topical dosage forms and bio equivalence approaches for transdermal dosage form and assessment of respiratory dosage form.

Track 10: Biosimilars Research Pipeline

The biological medical product is a biosimilar manufactured by a different company by the copy of an original product. The original biosimilar innovator products are officially approved biosimilar can be manufactured when the originally product patient expire. This session shall be highly useful for the biosimilar industry researchers to update themselves on the latest research updates from all over the world. Not only these sessions and also there are many ways to find the exact place for all the biosimilar exhibitions associated with present generation of biosimilars and biologics.

Track 11: Intellectual Property Rights

That any pharma product has successfully pass through the regulatory affairs scanners before launched in the market need less to mention. Biosimilars and biologics are no exceptions. The companies developing these biosimilars and biologics apart from regulatory aspects tend to enjoy monopoly over their product. Intellectual Property Rights (IPR) and patents are ultimate tools to the biosimilar manufacturers for safeguarding their interests. 2016 was a record year for development of Biosimilars & biologics in US. In this year 16 IPR petition was filed. So, expected scenario of 2017 would be a boom in Biosimilar and biologics field

Track 12: Brexit Effect on Biosimilar

The negative tendency of biosimilars Brexit impact. The hindrance towards the cost cutting approach taken by the NHS is a major setback towards approval and launch of biosimilars in market. With Britain being among foremost clinical preliminary focuses is claimed to see a diminishing in the eagerness of the makers and specialists to do any further preliminaries in Britain. Additionally, Brexit will cause the primary rationale of British Biosimilars Association (BBA) to fall back-which went for expanding the utilization of Biosimilars.

Track 13: Drug Delivery and Development

Medication Delivery Companies and Market session is starting to change for little, large, and medium scale pharmaceutical, Co biopharmaceutical Manufacturing and Industries, bland medications organizations, contract sedate conveyance organizations which can show from improvement to assembling. Tending to these dangers is an extraordinary test, because of the many-sided quality of the Clinical bio therapeutics themselves.

Track 14: Current Agency Expectations for Approval for Biosimilars

Biosimilars are a generally new subset of biopharmaceuticals, with the biotechnology business at last developing to such an extent that off-patent nonexclusive compose items progressively will enter real markets. Up until now, more than 20 biosimilars for a set number of reference items have been affirmed in real markets, principally the European Union. Just two items have been formally endorsed as biosimilars in the United States. The parent field of biopharmaceuticals itself keeps on displaying a poor supporting framework of data assets. Those biopharmaceutical and biosimilar data assets that do exist for the most part are restricted in number, assorted variety, and advancement

Track 15:  Biological Medicine:

Organic Medicine works with the science of the body and its regular recuperating capacities and in addition the otherworldly, passionate and physical parts of malady. Sickness implies that the body's direction isn't working legitimately and should be brought once again into its normal powerful state where the invulnerable framework is in full control. It in this manner searches for main drivers for the showing side effects of sickness the hidden elements making a man give a specific disease. These underlying drivers may comprise of a few elements which have developed after some time and can incorporate; consume less calories, sustenance sensitivities, intestinal unsettling influences, family history, push, ecological elements, substantial metals, dental issues, hyperacidity, injury, introduction to microscopic organisms or infections or electromagnetic aggravation

 

To Collaborate Scientific Professionals around the World

Conference Date Feb 28-March 01, 2019

For Sponsors & Exhibitors

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