7^th European Biopharma Congress July 29-30, 2019 Prague, Czech Republic

The assessment of BA/BE of different drug products is based on the fundamental assumption that two products are equivalent when the rate and extent of absorption of the test drug does not show a significant difference from the rate and extent of absorption of the reference drug when administered at the same molar dose of the therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses. Should the rate of absorption actually differ between products, it would have to be intentional and reflected in the proposed product label and be clearly demonstrated that it is not essential in the attainment of effective body drug concentrations on chronic use or has been shown to be medically insignificant for the drug. In practice, equivalence is indicated when key pharmacokinetic parameters used to establish rate and extent of the test, and reference products fall within a present confidence interval. The FDA declares a drug product to be therapeutically equivalent to the innovator product if it is pharmaceutically equivalent, i.e., same active ingredient, dosage form, strength and route of administration, and bioequivalent. Products that are therapeutically equivalent can be used interchangeably. Thus, BE studies are construed to be considered surrogates for comparative clinical trials for the assessment of therapeutic equivalence in safety and efficacy between two drug products.

Clinical Trials is a multidisciplinary program with broad participation with members from around the globe focused on learning about clinical research and its advances. This is your best opportunity to reach the largest assemblage of participants from Clinical Trials community that is from academia, clinical research entities, medical groups, related associations, societies and also from government agencies, pharmaceutical, biomedical and medical device industries. Clinical Trials will discuss various disciplines involved in the pre-clinical research, conduct of clinical trials; it will educate health care researchers about design, operation, organizing, research computing, regulatory aspects and reporting of clinical trials. It promotes better understanding by the general public about the importance of clinical trials in prevention, diagnosis and treatment of disease.

Drug design, often referred to as rational drug design or simply rational design, is the inventive process of finding new medications based on the knowledge of a biological target. The drug is most commonly an organic small molecule that activates or inhibits the function of a biomolecule such as a protein, which in turn results in a therapeutic benefit to the patient. In the most basic sense, drug design involves the design of molecules that are complementary in shape and charge to the bio molecular target with which they interact and therefore will bind to it. Drug design frequently but not necessarily relies on computer modelling techniques. This type of modelling is sometimes referred to as computer-aided drug design. Finally, drug design that relies on the knowledge of the three-dimensional structure of the bimolecular target is known as structure-based drug design. In addition to small molecules, biopharmaceuticals and especially therapeutic antibodies are an increasingly important class of drugs and computational methods for improving the affinity, selectivity, and stability of this protein-based therapeutics have also been developed.

Regulatory Science is the science of advanced standards equipment, and paths to assess the safety, Drug toxicity and quality, potency of all FDA-regulated products. An access to lengthen the programs in regulatory science that leverages what has been well-educated in the development of training programs for translational scientists, and this model for regulatory science program development is being refined and adopted by all of the institutions that are part of the CTSA network. The target audience for such a program is broad, noted that it is necessary to break out of the mind-set that regulatory science resides totally with FDA and that the field's purpose is to create a workforce that will function within the FDA. Regulatory science is a collaborative effort that goes beyond FDA. Critical needs for a regulatory science training program understand research and scientific methodology, toxicology, therapeutics, and pharmacology that underpin the regulatory process. The importance of intellectual property law is well established at all levels-statutory, administrative and judicial. It lays down minimum standards for protection and enforcement in member countries which are required to promote effective and adequate protection of intellectual property rights with a view to reducing distortions and impediments to international trade.

The Agreement provides norms and standards in respect of following areas of intellectual properties are Patents, Trademarks, copyrights, Geographical indications, Industrial designs

One of the big challenges of medicine today is to deliver drugs specifically to defected cells. Nano particulate drug carriers have the potential to answer to this call, as nanoparticles can cross physiological barriers and access different tissues, and also be provided in a targetable form aimed at enhancing cell specificity of the carrier. Recent developments within material science and strong collaborative efforts crossing disciplinary borders have highlighted the potential of mesoporous silica nanoparticles (MSNs) for such targeted drug delivery. Here we outline recent advances which in this sense push MSNs to the forefront of drug delivery development. Relatively straightforward inside-out tuning of the vehicles, high flexibility, and potential for sophisticated release mechanisms make these nanostructures promising candidates for targeted drug delivery such as ‘smart’ cancer therapies. Moreover, due to the large surface area and the controllable surface functionality of MSNs, they can be controllably loaded with large amounts of drugs and coupled to homing molecules to facilitate active targeting, simultaneously carrying traceable (fluorescent or magnetically active) modalities, also making them highly interesting.

Pharmaceutical sciences combine a broad range of scientific disciplines that are involved with the design, action, delivery, disposition and use of drugs. This field draws on many areas of the basic and applied sciences such as chemistry, biology, epidemiology, statistics, chemometrics, mathematics, physics and chemical engineering and applies their principles to the study of drugs.

The field of Pharmacovigilance is growing rapidly and its development is making tremendous impacts in medical sciences and pharmaceuticals. Euro Biopharma 2019  emphasizes on how the importance and significance can be gauged by the fact that it has made huge advancements over the course of time and is continuing to influence various sectors. With members from around the world focused on learning about Pharmacovigilance and its advances.

Good Manufacturing Practices quality of drugs is essentially the responsibility of manufacturers. GMP Guidelines are means to assure this very quality of drugs. CGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. GMP is actually good common sense quality management quality assurance GMP production and quality control.

Drug Delivery system attains greater global significance as Drug Delivery System plays a significant role in the future of pharmaceutical research Novel drug delivery system method by which a drug is delivered can have a significant effect on its efficacy. This includes topics like lipid Polymers to enhance drug delivery technology by providing controlled release of therapeutic agents in constant doses over long periods, cyclic dosage, and tuneable release of both hydrophilic and hydrophobic drugs. The major part is to deliver an innovative speech on the latest Targeted drug delivery is a method of delivering medication to a patient in a manner that increases the concentration of the medication in some parts of the body relative to other drugs.

The method by which a drug is delivered can have a significant effect on its efficacy. Some drugs have an optimum concentration range within which maximum benefit is derived, and concentrations above or below this range can be toxic or produce no therapeutic benefit at all. On the other hand, the very slow progress in the efficacy of the treatment of severe diseases, has suggested a growing need for a multidisciplinary approach to the delivery of therapeutics to targets in tissues. 

Clinical trials are research concentrates that investigate whether a restorative technique, treatment, or gadget is protected and compelling for people. Contemplate indicate which therapeutic methodologies work best for specific ailments or gatherings of individuals. The reason for clinical trials is research, so the reviews take after strict logical models. These measures ensure patients and help deliver dependable review comes about. Clinical trials are one of the last phases of a long and watchful research prepare.

 Clinical research concentrates to explore whether a remedial system, treatment, or device is ensured and effective for individuals. Consider show which therapeutic strategies work best for particular afflictions or gatherings of people

A Biopharmaceutical is also called as a Biological or Biologic pharmaceutical medication item fabricated from organic sources through extraction. The advancement of a pharmaceutical medication normally takes a normal of 10 – 15 years. Such a large amount of exertion, time and cash, it is exceptionally urgent that the correct advancements and materials are received in the examination, improvement and assembling of the pharmaceutical medications, whole process incorporates pre-disclosure, pre-clinical trials, showcase dispatch to post promoting observing. The wellsprings of medication items incorporate peptides and proteins, including monoclonal antibodies and neutralizer pieces. From 2000 to 2006, biologics represented 33% of all New Active Substances that were pre propelled, and are reflected to the present advancement pipelines of the pharmaceutical business.

Pharmaceutical Analysis is a process or a sequence of processes to identify and/or quantify a substance or drug, the components of a pharmaceutical solution or mixture or the determination of the structures of chemical compounds used in the formulation of pharmaceutical product. Analytical techniques mainly used for the separation of the components from the mixture and for the determination of the structure of the compounds. For the administration of drugs various chemical and instrumental methods were developed at regular intervals which are involved in the estimation of drugs. Analytical instrumentation and methods play an important role. Different analytical techniques and electrochemical methods like Chromatographic techniques, HPLC, Gas chromatography.  From the stages of drug development to marketing and post marketing, analytical techniques play a great role in understanding the physical and chemical stability of the drug, identification of impurities Analytical techniques are mainly used to determine the safety and efficacy of the drug.

The worldwide income of the statistical surveying industry surpassed 40 billion U.S. dollars in 2013, rising year-on-year since it encountered a slight plunge in 2009 amid the Great Recession. In 2013, Europe produced the biggest offer of statistical surveying income at 40 percent, or 16 billion U.S. dollars, nearly taken after by North America with 39 percent. Notwithstanding contributing the most income that year, Europe additionally observed the biggest decrease in income over the earlier year, falling by 1.4 percent.

Pharmacodynamics is the significance that drugs have on the main part; while pharmacokinetics is the study of the way in which drugs move through the body during absorption, distribution, metabolism and excretion. Pharmacokinetics influences decisions over the route of administration. For drugs to produce their effects they must interact with the body. This can ensue in several behaviours and depends on the properties of the drug, and will be discussed later in this chapter. Pharmacokinetics influences decisions over the route of administration. The processes that occur after drug admin can be fragmented down into four distinct areas (known as ADME).

Biopharmaceutical otherwise called a biologic therapeutic item or biologic, is any restorative item made in, extricated from, or semi orchestrated from organic sources. Not quite the same as synthetically incorporated pharmaceuticals, they incorporate immunizations, blood, or blood segments, allergenic, substantial cells, quality treatments, tissues, recombinant restorative protein, and living cells utilized as a part of cell treatment. Biologics can be made out of sugars, proteins, or nucleic acids or complex mixes of these substances, or might live cells or tissues. They are confined from normal sources—human, creature, or microorganism. Phrasing encompassing biopharmaceuticals fluctuates amongst gatherings and elements, with various terms alluding to various subsets of therapeutics inside the general biopharmaceutical class. Some administrative offices utilize the terms natural restorative items or remedial organic item to allude particularly to designed macromolecular items like protein-and nucleic acid–based drugs, recognizing them from items like blood, blood segments, or antibodies, which are typically extricated specifically from a natural source Gene-based and cell biologics, for instance, frequently are at the front line of biomedical research, and might be utilized to treat an assortment of therapeutic conditions for which no different medications are accessible

For developing a new medicine it will take nearly 10-15 years and on average and costs an average of $2.6 billion. In discovery procedure comprises the initial stages of research, which are intended to recognize an investigational drug and perform primary tests in the lab. This first stage of the process takes   three to six years. By the end, investigators hope to identify a capable drug aspirant to further study in the lab and in animal models, and then in people. These developments offer great ability, but also add complexity to the R&D process. In order to ensure the safety and efficacy of personalized therapies that are used along with diagnostics, clinical trial protocols must be improved and increased

Pharmaceutical analytic market analysis arrangement with the collection, analysis, and resolution of details and data acknowledgement to the market environment of a given pharmaceutical product – in general of a medical drug. The elementary use of pharmaceutical market analysis is to boost as realistic and objective as possible a response of the marketing opportunities of a given pharmaceutical product, thus developing the recognition of the chances and risks combined with its development potential as early on as possible

Pharmaceutical building is a piece of pharmaceutical science. Innovation which includes improvement and assembling of items, procedures, and parts in the pharmaceuticals business. The touchy advancement in the pharmaceutical business turned into the main thrust for our new Biopharmaceutical Engineering Program. The branch of biopharmaceuticals is quickly forming into upstream medication definitions and downstream plan handle, by utilizing biopharmaceutical designing standards

Pharmacotherapeutics manages the helpful uses and impacts of medications. Pharmacists are specialists in pharmacotherapy and are in charge of guaranteeing the protected, suitable, and prudent utilization of pharmaceutical medications. As pharmacotherapy masters, pharmacists have duty regarding direct patient care, regularly working as an individual from a multidisciplinary group, and going about as the essential wellspring of medication related data for other social insurance experts. A pharmacotherapy expert is a person who is spent significant time in managing and endorsing medicine, and requires broad scholarly information in pharmacotherapy.

A drug interaction is a situation in which a substance (usually another drug) affects the activity of a drug when both are administered together. This action can be synergistic (when the drug's effect is increased) or antagonistic (when the drug's effect is decreased) or a new effect can be produced that neither produces on its own. Typically, interactions between drugs come to mind (drug-drug interaction). However, interactions may also exist between drugs and foods (drug-food interactions), as well as drugs and medicinal plants or herbs (drug-plant interactions). People taking antidepressant drugs such as monoamine oxidase inhibitors should not take food containing tyramine as hypertensive crisis may occur (an example of a drug-food interaction). These interactions may occur out of accidental misuse or due to lack of knowledge about the active ingredients involved in the relevant substances.

They are experts in the field of medicines and are not only responsible for the dispensing of prescriptions but also the purchase, manufacture and quality testing of all medicines used in a hospital. Many hospital pharmacists are qualified to prescribe in their own right. Pharmacists work closely with medical and nursing staff to ensure that patients receive the best treatment, advising on the selection, dose and administration route. They also provide help and advice to patients in all aspects of their medicines.

In 2013, there were 287,420 pharmacists and 362,690 pharmacy technicians in the United States. Since 2003, the number of pharmacists in the U.S. has fluctuated year to year, but overall has increased approximately 19% in the last decade. The number of pharmacy technicians steadily increased in the same period, adding over 170,000 workers from 2003-2018.

Industrial pharmacy is a discipline which includes manufacturing, development, marketing and distribution of drug products including quality assurance of these activities. The research topics are focussed on solving current general problems in pharmaceutical industry, such as formulation and characterisation of sticky amorphous drugs, problem-solving for paediatric medicines and miniaturisation of manufacturing processes

Pharmaceutical Packaging can be defined as an economical means of providing presentation, protection, identification information, containment, convenience and compliance for a product during storage, carriage, display and until the product is consumed. Packaging must provide protection against climatic conditions biological, physical and chemical hazards and must be economical. Pharmaceutical marketing is based on product type and geography. The pharmaceutical packaging market is constantly advancing and has experienced annual growth of at least five percent per annum in the past few years as with most other packaged goods, pharmaceuticals need reliable and speedy packaging solutions that deliver a combination of product protection, quality, tamper evidence, patient comfort and security needs

Biotechnology is the utilization of living frameworks and creatures to make items, by any innovative applications to make or adjust items or procedures for particular utilize. Science and innovation have in the past assumed an indispensable part in enhancing general wellbeing. Today the commitment of science to enhance general wellbeing and lessen worldwide wellbeing incongruities is more apropos than any other time in recent memory. However the advantages of current medication still have not achieved a huge number of individuals in creating nations. The developing wellbeing variations between the creating and the created world call for critical activity from established researchers.

Pharmaceutical Care is a patient-centred, outcomes oriented pharmacy practice that requires the pharmacist to work in concert with the patient and the patient's other healthcare providers to promote health, to prevent disease, and to assess, monitor, initiate, and modify medication use to assure that drug therapy regimens are safe and effective. 

A good health system delivers quality services to all people, when and where they need them. The exact configuration of services varies from country to country, but in all cases requires a robust financing mechanism; a well-trained and adequately paid workforce; reliable information on which to base decisions and policies; well maintained facilities and logistics to deliver quality medicines and technologies.

Genetics is the study of genes, heredity, and genetic variation in living beings. It is basically considered a field of biology, but it bisect often with many of the life sciences like Pharmaceutical Sciences. The other aspects of this are Genetic engineering, Biomedical Engineering, Genomics Proteomics, Clinical engineering, Tissue engineering, biomedical data engineering etc.

The global genetic engineering market is expected to reach $3,514.08 Million by 2019 from $1,845.25 Million in 2014, growing at a CAGR of 13.75%. Increased RandD expenditure and growth of biotechnology and pharmaceutical industries, increased funding for genomics research, and technological advancements are the primary growth drivers for this market during the forecast period (2014–2019).

Formulation studies involve developing a preparation of the drug which is both stable and acceptable to the patient. For orally administered drugs, this usually involves incorporating the drug into a tablet or a capsule. It is important to make the distinction that a tablet contains a variety of other potentially inert substances apart from the drug itself, and studies have to be carried out to ensure that the encapsulated drug is compatible with these other substances in a way that does not cause harm, whether direct or indirect. Formulation studies also consider such factors as particle size, polymorphism, pH, and solubility, as all of these can influence bioavailability and hence the activity of a drug. Drug Manufacturing is the process of industrial-scale synthesis of pharmaceutical drugs by pharmaceutical companies. The process of drug manufacturing can be broken down into a series of unit operations such as Milling, Granulation, Coating, Tablet pressing and others. Statistics are critical to the Pharmaceutical industry, from clinical operations through manufacturing. However, clinical and manufacturing statistics represent entirely different worlds. Where they might be well staffed on the clinical side, some Pharmaceutical companies today aren’t hiring qualified staff to analyze operations data, resulting in misapplied tools, inadequate CAPAs and superficial root cause analysis, all of which lead to financial loss and noncompliance