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World Congress on Bioavailability and Bioequivalence (PGR)

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World Congress on Bioavailability and Bioequivalence

About this Event

BABE 2019 welcomes attendees, presenters, and exhibitors from all over the world to London. We are delighted to invite you all to attend and register for the “World Congress on Bioavailability and Bioequivalence” which is going to be held during November 11-12, 2019 in London, UK

BABE 2019 has been designed in an interdisciplinary manner with a multitude of tracks to choose from every segment in Pharma, Clinical research, Bioavailability, and Bioequivalence, which provides you with a unique opportunity to meet up with peers from both industry and academia and establish a scientific network between them. We cordially invite all concerned people to come to join us at our event and make it successful by your participation.

At PULSUS Group, it is our ideology to bring maximum exposure to our attendees, so we make sure the event is a blend which covers professionals such as Pharmaceutical Scientists, Veteran Researchers, Healthcare Professionals from academia & industry making the BABE 2019 conference a perfect platform.

The conference will be organized around the theme ‘The difference in increased Bioequivalence and increased Bioavailability - Unwinding Innovations’. Our goal is to deliver an outstanding program which covers the entire spectrum of research & innovations in Pharmacology, Bioavailability, and Bioequivalence and share the cross-cultural experiences of various treatment procedures.

BABE 2019 is an annual meeting of Bioavailability and Bioequivalence organizations as well as committees to discuss the future of the quality drugs in terms of collaboration, structures, and organizational development.

Who should attend:

  • Pharmaceutical Scientists
  • Pharmacologists
  • Clinical Scientists
  • Toxicologists

This course is also designed for professionals working in the following areas:

  • Clinical Drug Development
  • Quality Assurance
  • Regulatory Affairs
  • Project Management
  • Bio-analytics
  • Biostatistics
  • IVIVC
  • R&D

2019 Highlights:

  • 100+ Participation (50% Industry: 50% Academia)
  • 9+ Keynote Speakers
  • 30+ Plenary Speakers
  • 3+ Exhibitors
  • 17 Innovative Educational Sessions
  • B2B Meetings

Why to attend???

With members from around the world focused on learning about the standards in Pharmaceuticals, drug research, and development; this is your best opportunity to reach the largest assemblage of participants from the Pharma community. Conduct presentations, distribute information, meet with current and potential scientists, make a splash with new discoveries in the quality of drug products, pharmacokinetic measurements, bioavailability, and bioequivalence and receive name recognition at this 2-day event. World-renowned speakers, the most recent techniques, developments, and the newest updates in Pharma are hallmarks of this conference.

Conference Opportunities:

For Researchers and Faculty Members:

  • Speaker Presentations
  • Poster Display
  • Symposium hosting (4-5-member team)
  • Workshop organizing

For Universities, Associations & Societies:

  • Association Partnering
  • Collaboration proposals
  • Academic Partnering
  • Group Participation

For Students and Research Scholars:

  • Poster Competition (Winner will get Best Poster Award)
  • Young Researcher Forum (YRF Award to the best presenter)
  • Student Attendee
  • Group Registrations

For Business Delegates:

  • Speaker Presentations
  • Symposium hosting
  • Book Launch event
  • Networking opportunities
  • Audience participation

For Product Manufacturers:

  • Exhibitor and Vendor Booths
  • Sponsorship opportunities
  • Product launch
  • Workshop organizing
  • Scientific Partnering
  • Marketing and Networking with clients

Sessions/Tracks

Advances in Bioavailability

when medicine is levelled intravenously, its bioavailability is 100%. As it may, when medicine is controlled through different courses (orally) its bioavailability by and large moderations (Reason- inadequate assimilation and first-pass digestion system) or may swing from patient to patient. Bioavailability is one of the pivotal tackles in pharmacokinetics, as bioavailability must be considered when figuring doses for non-intravenous courses of an organization.

  • Oral Bioavailability
  • Absolute Bioavailability
  • Relative Bioavailability
  • Pharmacokinetic

Fostering in Bio-equivalence

Bioequivalence is the similitude of two drugs that portion the same desired outcome for patients. Pharmaceutical equivalence means two drugs deliver the active components into the bloodstream at the same amount and the same rate. When gauge how well a generic drug work, scientists evaluate its bioequivalence to the name-brand version.

  • Pharmacokinetic studies
  • Pharmaceutical
  • In Vivo
  • In Vitro

BA/BE Studies

BA/BE studies are needed by a directive to guarantee remedial correlation between a pharmaceutically equivalent test item and a remark item. BA/BE studies are finished Early and late clinical trial precision, Formulations applied as a part of clinical trial and steadiness studies. Everybody has more layered on their plate than any time in recent tribute, and abundant consultants discover themselves always re-organizing their work exercises.

  • Identical therapeutic moiety
  • Pharmaceutical Equivalence
  • Abbreviated New Drug Application

Pharmacology Research

Pharmacology is the portion of science concerned about the examination of medication activity, where medication can be broadly characterized as any synthetic, regular particle which applies a biochemical or physiological effect on the cell, tissue, organ, or creature. Even more particularly, it is the investigation of the associates that happen between a living life form and synthetic mixtures that influence ordinary or odd biochemical capacity. On the off coincidental that substances have therapeutic properties, they are alleged about pharmaceuticals. Pharmacology has main two parts, pharmacodynamics and pharmacokinetics.

  • Toxicology
  • Antipathogenic capabilities
  • Ecopharmacovigilance
  • ImmunoPharmacology

Clinical Drug trials

A clinical trial is a research study that finds new ways to prevent, diagnose or treat disease. Cancer clinical trials test new treatments in people with cancer. These treatments investigate promising new medication, drug mixtures, new approaches to surgery or irradiation, and advances in new areas like cistron medical aid. Clinical trials area unit the ultimate step in an exceedingly long method. Testing of a replacement cytotoxic drug or treatment is finished in an orderly series of steps known as phases.

Phase 1 trial: Determine a safe dosage range and identify side effects.

Phase 2 trial: The drug or treatment works in people who have a certain disease or condition

Phase 3 trial: Use drugs or treatments and collect data that may permit the drug or treatment to be used safely.

Phase 4 trial: Area unit conducted once a drug or treatment has been approved to be used within the general public.

  • Observational clinical trials
  • Interventional clinical trials

Pharmacodynamics

Pharmacodynamics is described as what a drug does to the body & is the study of the biochemical, physiologic, and molecular effects of drugs on the body and involves receptor sensitivity, post receptor effects, and chemical interactions. Pharmacodynamics, with pharmacokinetics (the branch of pharmacology concerned with the movement of drugs within the body) helps to explain the relationship between the dose and response. The medicine response depends on the drug binding to its target.

  • Pharmacokinetic-pharmacodynamic
  • Pharmaceutical drugs

European Bioequivalence

The European Medicines Agency's (EMA) product specific bioequivalence indicates the outline harmonised regulatory desires for studies to demonstrate bioequivalence for merchandise that may have specific desires owing to their material medical, additionally to those outlined in general guidance. As such they are potentially very useful to the pharmaceutical industry in the development of generic medicinal products and to regulatory authorities for harmonized decision making.

  • Generics
  • Biowaiver
  • In Vitro dissolution

Biopharmaceuticals

Biopharmaceuticals are medical drugs produced using biotechnology. They are proteins (including antibodies), nucleic acids (DNA, ribonucleic acid or antisense oligonucleotides) used for therapeutic or in vivo diagnostic functions and are created by suggests that except for direct extraction from a native (non-engineered) biological source.

  • Monoclonal Antibodies Process
  • Vaccines and Viral Therapy Process
  • Plasma Process
  • ADC Process

Biosimilars

A biosimilar product is a biologic product that is accepted based on representing that it is highly similar to an FDA approved biologic product, known as a reference product, and has no clinically meaning variations in terms of safety and effectiveness from the reference product.

  • SBP (Similar biologic Product)
  • FOB (Follow-On Biologic)
  • SEB (Subsequent Entry Biologic)

Pharmacokinetics

Pharmacokinetics is the study of a drug absorption, distribution, metabolism and elimination from the body. Pharmacodynamics describes what the drug ensures to the body. These pharmacokinetic properties determine the onset, intensity, and the duration of drug action in body. First of all the drug absorption from the site of administration permits the entry of a drug to the plasma. Secondly drug then leave plasma and distribute to the interstitial and intracellular fluids. Third, the drug is metabolized by liver and other tissues. finally, drug and its metabolites are eliminated from the body in urine, bile and feces. Pharmacokinetics mean the drug and their movements in the body. In general terms, it can be explained as an effect of drug or chemical entity on body upon administration. These four features include:

  • Absorption
  • Distribution
  • Metabolism
  • Elimination

Bio-equivalence Study protocol

The aim of bioavailability study is to search out the dosage type influence on the biological performance of the drug, sensitivity to find variations within the rate and extent of absorption. A study style meant for estimating essential pharmacokinetic parameters differs considerably from a bioequivalence study meant for comparison the take a look at formulation with respect to a customary. Factors have to be considered in conducting a bioavailability study are rate and extent of absorption of a drug into the systemic circulation.

  • Pharmaceutical equivalence
  • Therapeutic Equivalence
  • Genetic Phenotyping

Drug Design and evolution

Drug Design defines the look of molecules that square measure complementary in form and charge to the building block target with that they move and so can bind to that. Drug development is that the method of delivery a replacement pharmaceutical drug to the market once a lead compound has been known through the method of drug discovery.

  • Ligand-based drug design
  • Rational drug discovery
  • Computer-aided drug design
  • Structure Base Drug Design

Regulatory Phenomenon

Failure at any stage would mean a large loss for the corporate. Hence, a lot of planning is required even before the project is underway. Recently, with the use of technology the process is becoming a less risky business, because of the ability of the computers to predict the possible outcomes. This will surely reduce the efforts in fruitless directions. Hence, the most important and most common biological targets for drug discovery are either enzymes regulating the biochemistry or the receptors through which many hormones and endogenous effectors show their response.

  • European Guidelines
  • FDA Guidelines
  • WHO Guidelines

Pharmacovigilance

Pharmacovigilance is outlined because the science and activities involved with the detection, assessment, understanding and hindrance of adverse reactions to medicines (i.e. adverse drug reactions or ADRs). The goal of this activity is to enhance the safe and rational use of medicines, thereby up patient care and public health.

  • Adverse Drug Reaction (ADR)
  • Adverse Event
  • Serious Adverse Event

Public Health & Nutrition

Public health nutrition is the science of preventing disease, extending life and promoting health through the medium of nutrition. The aim of these operating as public health nutritionists is for everybody to realize larger health and well-being by creating healthier food and nutrition-related selections. Public health refers to any or all organized measures (whether public or private) to forestall illness, promote health, and prolong life among the population. Its activities aim to produce conditions within which individuals is healthy and specialise in entire populations, not on individual patients or diseases. Thus, public health is concerned with the total system and not only the eradication of a disease.

  • Macronutrients
  • Micronutrients

In-vitro & In-vivo Bioequivalence studies

In-Vivo Bioequivalence studies:

The following sequence of criteria is beneficial in assessing the requirement for in vivo studies:

1. Oral immediate-release merchandise with general action- Indicated for serious conditions requiring assured response. Narrow therapeutic margin. Pharmacokinetics difficult by absorption seventy nada. Unfavourable physiochemical properties, e.g. low solubility, metastable modification, instability, etc. Documented evidence for bioavailability problems. No relevant information on the market, unless justification by somebody that in vivo study isn't necessary.

2. Non-oral immediate-release products.

3. Modified-release products with systemic action

In vivo bioequivalence studies are conducted with in usual manner as mentioned for bioavailability studies, i.e. the pharmacokinetic and the pharmacodynamic methods.

In-vitro Bioequivalence studies:

In vitro studies, i.e. dissolution studies are also used in position of in vivo bioequivalence below bound things, referred to as biowaivers.

1. The drug product differs solely in strength of the active substance It contains, provided all the subsequent conditions hold.

2. The drug product has been slightly reformulated, or the manufacturing technique has been slightly modified by the initial manufacturer in ways in which during which can convincingly be argued to be impertinent for the bioavailability.

3. The drug product meets all the following necessities

4. a suitable IVIVC and therefore the in vitro dissolution rate of the new product is equivalent there upon of the already approved healthful product.

  • Pharmacokinetic Methods
  • Pharmacodynamics Methods
  • IVIVC (In-Vitro In-Vivo Correlation)
  • IVIVR (In-Vitro In-Vivo Relation)

FDA in Bio-equivalence

The Unites States Food and Drug administration (FDA) has defined bioequivalence as. “the absence of a major distinction within the ratee and extent to that the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes obtainable at the site of drug action when administered at the same molar dose under the similar conditions in an appropriately designed study.

  • IND (Investigational New Drug)
  • NDA (New Drug Application)

Biowaiver

The term biowaiver is functional to a regulatory finished pharmaceutical product sanction method once the record (application) is approved supported proof of equivalence completely different than through in vivo equivalence testing In Vivo Bioavailability

  • BCS Class I
  • BCS Class II
  • BCS Class III
  • BCS Class IV

Market Analysis

About Bioavailability and Bioequivalence

Bioavailability means the rate and extent to which the active drug ingredient or therapeutic moiety is absorbed and becomes available at the site of drug action. The property where two drugs with identical active ingredients or two different dosage forms of the same drug possess similar bioavailability and produce the same effect at the site of physiological activity is Bioequivalence.

The scope of Bioavailability and Bioequivalence

Many countries have established a number of procedures for the introduction of generic pharmaceutical products. These generic products should be demonstrated to be therapeutically equivalent to a previously approved product in order to protect the customer. The concept of bioavailability and bioequivalence became a public issue because of the concern that a generic product might not be as bioavailable as that manufactured by the innovator. The therapeutic equivalence of a generic and an innovator product is mostly based on the demonstrated bioequivalence, that is, clinically insignificant differences in the rate and extent of drug absorption usually assessed from pharmacokinetic measurements. Along with the growth of the worldwide generic pharmaceutical industry, bioequivalence has added another dimension to the issue of quality of drug products. In the last few decades, the bioavailability and bioequivalence of drug products have emerged as important national and international regulatory and scientific issues. The concept of bioavailability/bioequivalence plays an important role in drug research and development, especially in the generic-drug industry.

Bioavailability, Bioequivalence and Drug Product Selection Process

  • Invitro & In-vivo techniques for investigating drug metabolism
  • Assessment of pharmaceutical quality & in-vivo performance of generic drugs
  • Impact of physical and chemical properties of a drug
  • Issues and concerns pertaining to bioavailability and bioequivalence

Why London

In European Countries, a guideline specifies that ‘the bioavailability of an active substance from a pharmaceutical product should be known and reproducible’. London is the capital of the United Kingdom, has a large, well-developed pharmaceutical market and offers universal health coverage to its citizens. There are many Universities in London offering the courses and encouraging researches on Pharmaceutical Science by understanding the importance and demand of Pharma Scientists in Public and Private Sectors. Pharmacists are in high demand across the UK and the outlook for qualified and experienced Pharmacists is very positive. London has many hospitals and Universities with advanced technology to treat patients. So, join with us to meet the Pharma Scientists around the word at a single place, the beautiful, resourceful and research city, London.

Apart from study and research, the modern Coca-Cola London Eye, to the historic Tower of London, the tourist attractions in London are a must-see on any London sightseeing trip. Many London tourist places are free to visit, while others are available with discounted entry or special offers. There are also plenty of kid-friendly places to visit in London. Find the underwater creatures at SEA LIFE London Aquarium or explore the Science Museum, London's interactive hub of science and technology. Both are perfect for fun family days out in London. Get to know some of the cultures at London museums, visit the Queen at Buckingham Palace, or take the perfect picture with Big Ben; just some of the many iconic places to go in London

Major Pharmaceutical Associations around the Globe

  • American Association of Pharmaceutical Scientists (AAPS)
  • International Pharmaceutical Federation (FIP)
  • International Pharmaceutical Students' Federation (IPSF)
  • Royal Netherlands Chemical Society
  • The European Bioanalysis Forum
  • BEBAC Consultancy Services for Bioequivalence and Bioavailability
  • European Federation of Pharmaceutical Industries and Associations (EFPIA)
  • European Generics and Biosimilar Medicines Association (EGA)
  • Canadian Generic Pharmaceutical Association (CGPA)
  • Generic Pharmaceutical Association (GPhA)
  • ORPHANET Parenteral Drug Association
  • Association of the British Pharmaceutical Industry (ABPI)

Societies/Industries Associated with Pharmaceutical Technology and Development

  • International Society of Pharmaceutical Compounding (ISPhC)
  • International Young Pharmacists' Group (YPG)
  • Parenteral Drug Association (PDA)
  • Regulatory Affairs Professionals Society (RAPS)
  • Society for Biomolecular Sciences
  • Society for Cell Science
  • Chugai Pharma (UK) Ltd
  • Genpharm
  • BioPharma
  • Amgen
  • Elis Pharmaceuticals Limited
  • Alliance Global

Universities in the UK providing Pharmacy Courses:

  • Anglia Ruskin University
  • Queen Mary University of London
  • UCL School of Pharmacy
  • King’s College London
  • Westminster
  • London Metropolitan
  • University of Bristol
  • University of Nottingham
  • University of Liverpool
  • Cardiff University
  • University of Birmingham
  • Robert Gordon University
  • University of Leeds
  • Kingston University

Why you should attend conference/lectures:

  • To sharpen your skills
  • Meet Experts & Influences Face to Face
  • Networking Opportunities
  • Learning in a New Space
  • Break Out of Your Comfort Zone
  • New Tips & Tactics
  • The Energy of Like-Minded Individuals
  • The Serendipity of the Random Workshop
  • Invest in Yourself
  • Have Fun

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