7th European Biosimilars Congress May 15-16, 2017 Munich, Germany

7^th European Biosimilars Congress 2017 organizing Committee invites you to attend the largest assemblage of biologics and biosimilars researchers from around the globe during May 15-16, 2017 at Munich, Germany. 

European Biosimilars Congress is a global annual event. This European Biosimilars Congress 2017 will bring together scientists, researchers, business development managers, CEOs, directors, IP Attorneys, Regulatory Officials and CROs from around the world. The passage of biosimilars through a decade at Europe finds much requirement for discussion also focussing the latest developments in the field of biologics and biosimilars. A comprehensive approach for the discussion has been taken up as listed below under several tracks and sub-tracks below:

Track 1: Current Challenges of Biologics

The development of biologics calls for overcoming lot many challenges. With initial steps of concepts of biologics, their considerations, essentials for early clinical developments it is very much needed that proper scientific and strategic approaches are taken for the successful development of follow-on-biologics. Moreover, the need for overcoming the challenges continues in the late clinical steps, drug safety factors and labelling requirements. Also it is much required now to develop a drug product in accordance to quality by design (QbD).

This Euro biosimilars conference will look at the multiple facets of current challenges in biosimilar development. This biosimilar conference will focus on multiple aspects of biosimilar product development to successfully deliver safe, potential and efficacious biologic products to the market.

Related Biosmilar Events| Biosimilar Conferences:

12^th World Pharma Congress October 16-18, 2017 Budapest, Hungary; 8^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit June 26-27, 2017 San Diego, California, USA; World Congress on Biotherapeutics and Bioanalytical Techniques September 11-13, 2017 Dallas, USA; 11^th World Congress on Pharmaceutical Sciences and Innovations in Pharma Industry February 27- 28, 2017 Amsterdam, Netherlands.

BioSim-Spanish Association of Biosimilars |International Generic and Biosimilars Medicines Association | British Biosimilars Association | Asociación Española de Biosimilares | Generic Pharmaceutical Association |Medicines for Europe

Track 2: Emerging Biosimilars in Therapeutics

The explorations in the field of biologics have created a new avenue for the clinicians towards better disease management. The emerging biologics   have already manifested fruitful outcomes in treatment of ailments like those of psoriasis, rheumatic arthritis, certain cancers, inflammatory bowel disease (IBD) etc.

Emerging Biosimilar insulins are likely to enter the insulin landscape as patents for major branded insulin products start to expire in the next few years. The main theme of this track is to have sound knowledge in the emerging biosimilars like Recombinant blood products, therapeutic proteins, vaccines, Biosimilar anti-bodies, Growth hormones, Biosimilar peptides, therapeutic proteins and other biosimilar developments.

Related Biologics Conferences| Biologics Meetings:

3^rd International Conference and Expo on Drug Discovery & Designing September 25-27, 2017 Vienna , Austria; 13th International Conference and Exhibition on Pharmaceutical Nanotechnology July 24-25, 2017 Rome, Italy; International conference on Biotech Pharmaceuticals October 23-25, 2017 Paris, France; 5th International Conference and Exhibition on Pharmacognosy, Phytochemistry & Natural Products July 24-26, 2017 Melbourne, Australia.

Pro Generika | German Association of Generic Manufacturers| German Association of Research-Based Pharmaceutical Companies | German Association for the Pharmaceutical Industry | Generics and Biosimilars Initiative | The Biosimilars Resource Center | The Alliance for Safe Biologic Medicines

Track 3: Analytical Strategies for Biosimilars

Analysis of biosimilars and biologics forms to be one of the most important aspect towards the biologics and biosimilar development process. Biosimilars analytical methods for process development and validation as well as use of production technologies such as disposables and supply chain logistics can help companies establish facility flexibility.
This biosimilars global event also includes Bioanalytical methods, Formulation, Bioassay for comparability and potency testing, GMP protein analysis, LC/MS analysis for discovery, preclinical, and clinical programs.

Related Biosimilar Conferences| Biologics Workshops:

12^th World Pharma Congress October 16-18, 2017 Budapest, Hungary; 8^th World Congress on Bioavailability & Bioequivalence: BA/BE Studies Summit June 26-27, 2017 San Diego, California, USA; World Congress on Biotherapeutics and Bioanalytical Techniques September 11-13, 2017 Dallas, USA; 11^th World Congress on Pharmaceutical Sciences and Innovations in Pharma Industry February 27- 28, 2017 Amsterdam, Netherlands.

Generics and Biosimilars Initiative | The Biosimilars Resource Center | The Alliance for Safe Biologic Medicines |British Biosimilars Association | Asociación Española de Biosimilares | Generic Pharmaceutical Association |Medicines for Europe

Track 4: Regulatory Approach and Legal Issues of Biosimilars

Biosimilars are the generic version of biological. It is the new buzz word in pharmaceutical industry. Biosimilars are highly similar to licensed reference product not withstanding minor differences in clinically inactive components; also there are no clinically meaningful differences between the biologicals and the reference product in terms of safety, purity, and potency. This track includes: Licensing of biosimilars, Biosimilars regulation, Patent issues, BLA filing for biosimilars, Biosimilars  regulatory prospects of BRIC countries, a paradigm of traditional generics to biosimilars, Biowaiver approval for Biosimilars and other aspects of Biosimilar approvals. European Biosimilars Congress 2017 will provide an excellent and global opportunity to the scientists, partners and pharma leaders from Biopharmaceutical and Biotechnology industries to innovate and to explore the strategic market for Biosimilars and Biologics with a clear picture of the regulatory approach for biosimilars and biologics.  The Patient Protection and Affordable Care Act (PPAC Act) was signed into law in March 2010 in addition to the amendments in the Public Health Service Act (PHS Act) to create an abbreviated approval pathway for biosimilars and follow on biologics.  These new statutory provisions are often referred as the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). This track concentrates upon such legal bindings and the aspects of the BPCI Act that pertain to the biosimilars and biologics. This session on legal issues shall be very beneficial to research scientists from both academic backgrounds and also those from industry R&D. The Europe biosimilars, US biosimilars, Australian biosimilars, Canada origin biosimilars and UK biosimilars are expected to take control over the biosimilar market around the globe by 2017.

Related Biologics Meetings| Biosimilars Conferences:

3^rd International Conference and Expo on Drug Discovery & Designing September 25-27, 2017 Vienna , Austria; Global Summit on Emerging Orphan Drugs and Drug Abuse Aug 23-24, 2017 San Francisco, California, USA; 4^th International Conference on Clinical Trials September 11-13, 2017 San Antonio, Texas, USA; 12^th World Pharma Congress October 16-18, 2017 Budapest, Hungary.

Asociación Española de Biosimilares | Generic Pharmaceutical Association |Medicines for Europe | Pro Generika| The Biosimilars Resource Center | The Alliance for Safe Biologic Medicines |BioSim-Spanish Association of Biosimilars |International Generic and Biosimilars Medicines Association

Track 5: Innovative Approach for Biosimilars

Biosimilars is a biologic medical product which is copy of an original product that is manufactured by a different company. Biosimilars are officially approved versions of original biosimilar innovator products, and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. This session shall be highly beneficial for the biosimilar manufacturers. This session also finds place for all the biosimilar exhibitions associated with the field of biosimilars and biologics.

Related Biosimilars Meeting| Biologics Symposiums:

5^th International Conference on Clinical Pharmacy October 23-24, 2017 Orlando, Florida, USA; 4^th International Conference and Exhibition on Pain Medicine August 03-04, 2017 San Francisco, California, USA; 12^th World Pharma Congress October 16-18, 2017 Budapest, Hungary; 10^th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems March 13-15, 2017 London, UK.

German Association of Research-Based Pharmaceutical Companies | German Association for the Pharmaceutical Industry |BioSim-Spanish Association of Biosimilars |International Generic and Biosimilars Medicines Association | The Alliance for Safe Biologic Medicines

Track 6: Consequences of Brexit on Biosimilars

With Europe that paved way to the uptake of biosimilars over a decade ago, the consequences of Brexit would be potentially harder on UK. Presently UK is no more bound to follow the guidelines of EMA. Also research grants from Innovative Medicines Initiative and Horizon 2020 would no more be available to UK. All the same, EMA has its headquarters in London, UK. The thus arising complications would definitely have certain consequences on the Biosimilars scenario in UK and EU.

Related Biosimilar Conferences| Biologics Conferences:

9^th Annual European Pharma Congress July 10-12, 2017 Madrid, Spain; 9^th International Conference and Exhibition on Pharmacovigilance & Drug Safety July 17-19, 2017 Munich, Germany; 13^th International Conference and Exhibition on Pharmaceutical Nano technology July 24-25, 2017 Rome, Italy; 3^rd International Conference and Expo on Drug Discovery & Designing September 25-27, 2017 Vienna , Austria.

Pro Generika | German Association of Generic Manufacturers| German Association of Research-Based Pharmaceutical Companies| International Generic and Biosimilars Medicines Association | British Biosimilars Association| Medicines for Europe

 Track 7: Globalization of Biosimilars

This track discuses about the generic drugs impact on global biosimilar market and Cost and risk management, Adopting innovative mechanisms such as risk-sharing arrangement, European market for biosimilars.

Those who can attend the biosimilar meeting under this track are ones following Biologics/ Proteins/Biosimilar Products, New Biosimilar Development, Process Science, Biosimilar Market, Portfolio Management, Research & Development, Business Development, Business Operations and Scientific Affairs.

Related Biosimilar Conferences| Biologics Conferences:

11^th World Congress on Pharmaceutical Sciences and Innovations in Pharma Industry February 27- 28, 2017 Amsterdam, Netherlands; 9^th World Congress on Pharmacology September 04-06, 2017 Paris, France; 3^rd International Conference on Advanced Clinical Research and Clinical Trials September 20-21, 2017 Dublin, Ireland; 12^th Annual Pharma Middle East Congress Sep 25-27, 2017 Dubai, UAE.

BioSim-Spanish Association of Biosimilars |International Generic and Biosimilars Medicines Association | British Biosimilars Association | Asociación Española de Biosimilares | Generic Pharmaceutical Association |Medicines for Europe

Track 8: Clinical Development of Biosimilars

This track includes Clinical trials on major diseases Risk management, and quality affairs, Case studies, and clinical models, Transgenic animals, Targeted cell line development, Clinical biosimilar tracks.docx PK/PD studies, Toxicological studies and Aspects of genotoxicity tests. This track is designed for those who are having sound knowledge on clinical studies and clinicians prospects for biosimilars. Biosimilar guidelines on the above mentioned topics are also to be thrown light upon at this biosimilars conference.

Related Biosimilar Events| Biosimilars Conference:

5^th International Conference and Exhibition on Pain Research and Management October 05-06, 2017 London, UK; International Conference on Biotech Pharmaceuticals October 23-25, 2017 Paris, France; 10^th International Conference on Neuropharmacology and Neuropharmaceuticals Oct 23-24, 2017 Dubai, UAE; 10^th Asia-Pacific Pharma Congress May 08-10, 2017 Singapore.

Pro Generika | German Association of Generic Manufacturers| German Association of Research-Based Pharmaceutical Companies | German Association for the Pharmaceutical Industry | Generics and Biosimilars Initiative | The Biosimilars Resource Center | The Alliance for Safe Biologic Medicines

Track 9: Biosimilar Market & Cost Analysis

This track is concentrated towards the different reviews and forecasts regarding the scnario of Biosimilars market and follow on Biologics. The present status and future scenario of the market are best to be discussed during this session. Market researches from the first launching of biosimilar to the newest one till date prospects for a radical change in the pharmaceutical market. Market researchers, market analysts, industrialists would be the apt participants for this session at Euro Biosimilars 2017.

Related Biosimilar Events| Biosimilars Conference:

International Conference and Exhibition on Nanomedicine and Drug Delivery May 29-31, 2017 Osaka, Japan; 16^th Annual Medicinal & Pharmaceutical Sciences Congress July 03-05, 2017 Kuala Lumpur, Malaysia; 11^th International Conference on Pharmaco epidemiology and Clinical Research July 06-08, 2017 Kuala Lumpur, Malaysia; 9^th World Congress on BA/BE Studies and Biowaivers July 17-19, 2017 Melbourne, Australia.

Generics and Biosimilars Initiative | The Biosimilars Resource Center | The Alliance for Safe Biologic Medicines |British Biosimilars Association | Asociación Española de Biosimilares | Generic Pharmaceutical Association |Medicines for Europe

Track 10:  Pharmacovigilance on Biosimilars

This session of the European Biosimilars Congress 2016  looks into the future and FDA initiatives that have already been announced to include enhanced tracking and follow-up of post market issues, planned improvements in AERS, and pilots of new post market drug-monitoring strategies. Current challenges in pharmacovigilance, Adverse drug reactions with pharmaceutical products, Biosimilar guidelines for pharmacovigilance practice and pharmacoepidemiology are the points that shall be laid emphasis in this session.

Related Biosimilar Conferences| Biologics Meetings:

9^th Annual Congress on Drug Design & Drug Formulation October 19-21, 2017 Seoul, South Korea; 10^th International Conferences on Immunopharmacology and Immunotoxicology Nov 20-22, 2017 Melbourne, Australia; 17^th International Conference and Exhibition on Nanomedicine and Nanotechnology in Health Care Nov 23-24, 2017 Melbourne, Australia; 3^rd World Congress on Medicinal Plants and Natural Products Research October 02-04, 2017 Kuala Lumpur, Malaysia.

Pro Generika | German Association of Generic Manufacturers| German Association of Research-Based Pharmaceutical Companies| International Generic and Biosimilars Medicines Association | British Biosimilars Association| Medicines for Europe

Track 11: Entrepreneurs Investment Meet

Entrepreneurs who are willing to put in hard work and invest in the field of biologics and biosimilars will find this meeting the best place to properly shape their drive for the new endeavours. Also this meeting will help them find the best experts who can make their investment fruitful and worthwhile. The best technological knowhow, economical aspects, regulatory red tapes and profit shares involving biosimilars and biologics shall be discussed at this Euro Biosimilars Global Event.

Related Biosimilar Conferences| Biologics Meetings:

11^th World Congress on Pharmaceutical Sciences and Innovations in Pharma Industry February 27- 28, 2017 Amsterdam, Netherlands; 5^th International Pharmacy Conference August 31-September 01, 2017 Las Vegas, USA; 10^th Pharmacovigilance Congress Sep 21-22, 2017 Charlotte, USA; 10^th International Conference and Exhibition on Pharmaceutics & Novel Drug Delivery Systems March 13-15, 2017 London, UK.

Pro Generika | German Association of Generic Manufacturers| German Association of Research-Based Pharmaceutical Companies| International Generic and Biosimilars Medicines Association | British Biosimilars Association| Medicines for Europe

The Euro Biosimilars conference 2017 is owned to bring together the worldwide top pharmaceuticals, biotechnology and regulatory representatives under one roof that will provide them the best platform to update and share knowledge related to biosimilars and biologics. Hence, the International Biosimilar Conference will unfold the multiple facets of biosimilars, ranging from the evolving regulatory landscapes, biosimilar guidelines to the legal and economic aspects and the then current challenges in biosimilar development. This biosimilar conference will focus on a variety of aspects of biosimilar product development to successful delivery of safe, efficacious and potent biosimilar products to the market. By attending this biologics conference one will gain a comprehensive outlook on the key issues surrounding biosimilars. An important platform for Biosimilars stakeholders to discuss and share best practices in expediting development in the field of Biologics and Biosimilars is ought to be Euro Biosimilars 2017.