8^th European Biopharma Congress

Biopharmaceutical informatics endeavors to use information technology, sequence-and structure-based bioinformatics analyses, molecular modeling and simulations, and statistical data analyze towards biologic drug development. Development of databases containing the experimental data on biophysical stability, safety along with molecular sequence.

• Applications of computation in biologic drug development
• Physics-based molecular modelling
• Protein sequence-structural contexts and degradation reaction mechanisms
• De risk biopharmaceutical development
• Creation of databases and data mining
• Pre-clinical immunogenicity risk assessment of biotherapeutics

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.

• Synthesizing new medications
• Beginning of mass production
• Controlled drug release

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.

• Clinical trial market
• Genome annotation
• Single-nucleotide polymorphism
• Gene and protein expression

Pharmaceutical analytic market research deals with the collection, analysis, and interpretation of details and information relating to the market environment of a given pharmaceutical product – in general of a medical drug. The primary objective of pharmaceutical market research is to gain as realistic and objective as possible an impression of the marketing opportunities of a given pharmaceutical product, thus enabling the identification of the chances and risks associated with its development potential as early on as possible

• Pharmaceutical companies market
• Global Analytical Instrumentation Market in Pharmaceuticals
• Generic and Biosimilar Pharmaceuticals (GLOBAL) - Industry Report

In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which new candidate medications are discovered. Historically, drugs were discovered through identifying the active ingredient from traditional remedies or by serendipitous discovery. Later chemical libraries of synthetic small molecules, natural products or extracts were screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as classical pharmacology

• Drug Delivery from Plant Extracts
• Drug Disposition
• Drug Elimination

Medicate security is a noteworthy concentration of pharmaceutical microbiology. The most imperative commitment of microbiology to the pharmaceutical business is the improvement of anti-infection agents. Pathogenic microscopic organisms, growths and poisons delivered by microorganisms. The results of microbial digestion are all conceivable contaminants of prescriptions, however the current hereditary controls have empowered the creation of more improved medications. Antibodies are likewise a vital commitment of microbiology towards improvement of medications. Aside from medications and bio items advancement, microbiology assumes an essential part in quality control of a pharmaceutical research center. Anticipation of microbial tainting in pharmaceutical arrangements like injectables, eye drops, nasal arrangements and inward breath items.

• Assisted reproduction
• Transgene regulation
• Biopharmaceutical production

Pharmacodynamics and pharmacokinetics are two key areas of pharmacological medicine. Pharmacodynamics is that the study of the molecular, organic chemistry, and physiological effects of medicine on cellular systems and their mechanisms of action. PK focuses rather on how the body affects the drug, in terms of its absorption, metabolism, distribution and elimination. Today, pharmacologists use a range of techniques, together with genetic science, biological science and chemistry, to elucidate and manipulate the pharmacologic action of drugs for health functions. BA and BE ofttimes accept pharmacokinetic measures such United Self-Defense Group of Colombia to assess extent of general exposure and Cmax and Tmax to assess rate of systemic absorption.

• Advances in pharmacokinetic interactions
• Advances in pharmacodynamic interactions
• Drug and substance abuse
• Drug-drug interactions
• Systems Pharmacology
• Data monitoring for trials with an adaptive design

Biologics are medicines made from living cells through highly complex manufacturing processes and must be handled and administered under carefully monitored conditions. Biologics are used to prevent, treat, diagnose, or cure a variety of diseases including cancer, chronic kidney disease, autoimmune disorders, and infectious diseases. Biosimilars is exactly what its name implies — it is a biologic that is “similar” to another biologic drug already approved by the FDA. Under U.S. law, a biosimilar is approved based on a showing that it is “highly similar” to an FDA-approved biological product, known as a reference product. It may not have any clinically meaningful differences in terms of safety and effectiveness from the reference product.

• Biosimilar Electrophoresis and Formulation.
• Fluid chromotography
• Immunoassays
• Spectrometry
• Biosimilar research pipelines

Assume a key part in the medication improvement period for both new medication items and their non specific reciprocals. These studies are likewise critical in the post endorsement period within the sight of certain assembling changes. Data in the general arrangement of information that guarantee the accessibility of protected and successful pharmaceuticals to patients and experts. BA/BE studies has been resolved to have down to earth and general wellbeing esteem for pharmaceutical supporters, for administrative offices, and for patients and specialists.

• Universal approach about comparative bioavailability
• Bioavailability studies of new drugs
• bioavailability of generic drugs

Nanotechnology has been increasingly employed in drug delivery as it increases the drug dissolution rate, leading to enhanced drug absorption and bioavailability. Many nanostructures have been proposed for drug delivery, each one having their own advantages and drawbacks. This manuscript revises the use of lipid- and polymer-based nanostructures in the association of different extract, establishing a relation between the type of Nano systems and its preparation method to the different plant extracts and most abundant compounds. Depending on the method of extraction, plant extracts can contain an enormous variety of active molecules, such as phenolic compounds, essential oils, alkaloids, among others. In many cases, from a pharmacological point of view, it is interesting to work with crude extract or fractions instead of a single isolated compound. In any case, in order to achieve a final product some issues must be overcome, including poor stability, solvent toxicity, and low solubility of the bioactive compound.

• Plant extracts toxicity
• in vitro and in vivo biological activities
• Cyclodextrins

Pharmaceutical formulation is defined as the process in which different chemical substances are combined to produce a final medicinal product. The formulation studies involve developing a preparation of drug acceptable for patient. Formulation is the word often used in a way that includes dosage form. Formulation studies consider factors such as particle size, solubility, polymorphism and pH as all of these can influence bioavailability and hence the activity of a drug.

• Drug metabolism
• Biotransformation
• Glucuronidation
• Biorelevant dissolution

Pharmaceutical Nanotechnology based system deals with emerging new technologies for developing customized solutions for drug delivery systems. The drug delivery system positively impacts the rate of absorption, distribution, metabolism, and excretion of the drug or other related chemical substances in the body. In addition to this the drug delivery system also allows the drug to bind to its target receptor and influence that receptor’s signaling and activity. Pharmaceutical nanotechnology embraces applications of nanoscience to pharmacy as nanomaterials, and as devices like drug delivery, diagnostic, imaging and biosensor.

It is defined as the method by which a drug is delivered can have a significant effect on its efficacy i.e. the drug become more efficacious in order to minimize drug degradation, drug adverse effect, and in order to increase the drug bioavailability to produce better therapeutic effect. NDDS covers various aspects like pharmacokinetics & pharmacodynamics, non-specific toxicity, immunogenicity, bio recognition, and drug’s efficacy based on preferable approaches that include polymer science, pharmaceutical technology, dispensing pharmacy, packaging technology, bio conjugate chemistry, and molecular biology. NDDS based on two mechanism i.e. physical and biochemical. Physical mechanism is like dissolution, osmosis, absorption, distribution, bioavailability, excretion and diffusion. Biochemical mechanism is like gene-protein therapy, liposomes-niosomes, Nano-micro particles, Monoclonal antibodies.

• drug excretion
• Drug Safety and Availability
• Hepatic drug clearance
• Pharmacogenomics in elimination
• Toxicology in pharmacological studies

Drug Clearance can be defined as the plasma volume in the vascular compartment that is cleared of drug per unit of time. Total clearance gives an indication of drug elimination from the central compartment without reference to the mechanism of this process. For drugs that are eliminated by first-order kinetics, clearance is constant. Clearance by the kidneys is called renal clearance, and that by all other organs is referred to as nonrenal clearance. The latter most often represents clearance by the liver. Total clearance is the sum of all body clearances. The same factors that determine renal and hepatic elimination of drugs affect drug clearance.

• GMP Guidelines (cGMP) & GxP in Pharmaceuticals
• Regulations and Quality Standards
• Good Clinical Practices and Good Laboratory Practices

A drug interaction is a reaction between two (or more) drugs or between a drug and a food, beverage, or supplement. Taking a drug while having certain medical conditions can also cause a drug interaction. For example, taking a nasal decongestant if you have high blood pressure may cause an unwanted reaction. A drug interaction can make a drug less effective, increase the action of a drug, or cause unwanted side effects. Food or beverages can affect the absorption of some HIV medicines and increase or reduce the concentration of the medicine in the blood. Depending on the HIV medicine, the change in concentration may be helpful or harmful. Directions on how to take HIV medicines specify whether to take the medicine with food, without food, or either way if the HIV medicine isn’t affected by food.

• Synthetic Organic Chemistry
• Structured and fragment based Drug Design
• Molecular Modeling
• Pro Drug synthesis & Drug Targeting
• Current Research in Medicinal Chemistry
• Drug Discovery & Development

Assumes a focal part all through pharmaceutical innovative work. These studies help in the disclosure and determination of new compound elements, bolster wellbeing evaluation, and are basic in characterizing conditions for protected and successful use in patients. ADME contemplates give the main premise to basic judgments from circumstances where the conduct of the medication is comprehended to those where it is obscure.

Disintegration has become an important and broadly used test receiving more accentuation worldwide from regulatory specialists amid the last 15 years. It is a critical quality control excessively and a guide, making it impossible to formulation development. Dissolution testing measures change on stability, and is utilized to build up in-vitro in-vivo correlations for some products. The disintegration test has experienced changes and updates subsequently of the expanded regulatory interest and the pharm practical industry's examination of aspects of disintegration testing to additionally enhance and get it the technique.

• Formulation and preformulation
• Developing a preparation of the drug
• Formulation types
• Formulation from plant sources
• Quality of Formulation
• Granulated formulations

Medicinal chemistry  are disciplines at the intersection of chemistry, especially synthetic organic chemistry, and pharmacology and various other biological specialties, where they are involved with design, chemical synthesis and development for market of pharmaceutical agents, or bio-active molecules (drugs)

Drug delivery refers to approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect.

Pharmacognosy & Phytochemistry is identified with the therapeutic plants. Pharmacognosy is the investigation of substance and organic properties of medications in restorative plants what gives new medications. Phytochemistry which induces the second metabolic development to defend from dreadful little creatures and developments. Pharmacognosy is the examination of medications from consistent sources. The American Society of Pharmacognosy describes as "the examination of the physical, compound, biochemical and natural properties of pharmaceuticals, medicine substances or potential meds or solution substances of regular initiation and also the search for new prescriptions from typical sources. Phytochemistry is the strict sentiment the word the examination of phytochemicals. These are chemicals gotten from plants. In a little sense, the terms are consistently used to portray the broad number of discretionary metabolic blends found in plants. Countless are known to give confirmation against bug ambushes and plant diseases. They moreover demonstrate different cautious capacities with regards to human buyers. Phytochemistry is for the most part used as a piece of the field of Chinese medicine especially in the field of a home developed solution.

• Plant Extraction methods
• Herbal drugs and Formulations
• Ethnopharmacology
• Plant physiology and Biochemistry

Good Manufacturing Practice is the part of quality management which ensures that products are consistently produced and controlled according to the quality standards appropriate to their intended use and as required by the marketing authorization, clinical trial authorization or product specification. Good Manufacturing practices conference aims at both production and QC. Current Good Manufacturing Practices (cGMP) is aimed primarily at managing and minimizing the risks inherent in pharmaceutical manufacture to ensure the quality, safety and efficacy of products. FDA regulates the quality of pharmaceuticals very carefully. Current Trends in the FDA is the main regulatory standard for ensuring pharmaceutical quality

By definition Pharmaceutical Industry is a discipline which incorporates manufacturing, development, marketing and distribution of drug products including quality assurance of these activities. This wide research region identifies with various capacities in pharmaceutical industry and having contact areas with engineering and economics. Pharmaceutical Industry is a complex, multi-factorial condition, with the general point of manufacturing, developing and marketing safe and efficacious medicines including quality assurance of these activities. Research in Industrial Pharmacy is done both locally and under the direction of Faculty of Pharmacy.

The Pharmaceutical sciences combine broad range of scientific disciplines that are critical to the discovery and development of new drugs and therapies. Pharmaceutical Sciences is a dynamic and interdisciplinary field that aims to integrate fundamental principles of physical and organic chemistry, engineering, biochemistry, and biology to understand how to optimize delivery of drugs to the body and translate this integrated understanding into new and improved therapies against human disease. At the many of institutes internationally recognized faculty contribute to the field through inquiry into the underlying mechanisms of drug interactions with the human body and development of advanced synthetic or biologically-derived materials that can modulate these interactions in pursuit of better and safer therapies and drug products.

Pharmacodynamics & Pharmacokinetics parameters become important because of the association between host drug concentrations, microorganism eradication, and resistance. Since long scientific advances allowed scientists to come together with the study of physiological effects with biological effects. The Pharmaceutical industry's long successful strategy of placing big bets on a few molecules, promoting them heavily and turning them into blockbusters worked well for many years, but its R&D productivity has now plummeted and the environment’s changing

The main aim of pharmacovigilance is to provide complete and clear information related to drug safety and various risks and benefits associated with them. Pharmacovigilance can help in providing information of unintended and severe adverse events which could not be provided by clinical trials involving in-vivo method. It enhances the impact of pharmacovigilance on patient welfare and public health and to know what is pharmacovigilance. This track gives a brief discussion on Pharmacovigilance role in healthcare system.

Packaging is one of the largest industry sectors in the world, worth several billions. Pharmaceutical packaging represents a meager percentage of this colossal market. The global healthcare industry has seen a shift in paradigm and is now skewed toward effective and meaningful packaging. Packaging was considered as an afterthought which was required merely in the final stages of manufacturing for many pharmaceutical companies about a decade ago.

Regulatory affairs are a new profession which is developed by the governments to protect public health. The main aim is controlling the safety and efficacy of products in areas including pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals and cosmetics. Regulatory affairs also have a very specific meaning within the healthcare industries

The development of the pharmaceuticals brought a revolution in human health. These pharmaceuticals would serve their intent only if they are free from impurities and are administered in an appropriate amount. To make drugs serve their purpose various chemical and instrumental methods were developed at regular intervals which are involved in the estimation of drugs. he review highlights a variety of analytical techniques such as titrimetric, chromatographic, spectroscopic, electrophoretic, and electrochemical and their corresponding methods that have been applied in the analysis of pharmaceuticals.

A Radiopharmaceutical is a drug that can be used either for diagnostic or therapeutic purposes. It is composed of a radioisotope bond to an organic molecule. The organic molecule conveys the radioisotope to specific organs, tissues or cells. The radioisotope is selected for its properties. The global radiopharmaceuticals market was worth US$3.8 billion in 2011 and is expected to be growing at a stupendous CAGR of 18.3% to reach a value of US$12.2 billion by 2018.