Conférences - Législation en médecine et pharmacologie

ASVAC 2019 aims to bring together various stakeholders in the field of vaccination to address challenges and issues relevant to clinical practice and immunization programs in the region.

Tél.: [(+65) 6389 6640];     Email.: lteopaco@kenes.com

vaccination, clinical practice and immunization

Pharmacologie et développement des médicaments,    Épidémiologie

This conference overviews and integrates the business and technical problems that pharmaceutical companies should be aware of in order to fight the major global problem of counterfeit medicines. In addition to discussion of the problems, this conference addresses serialisation; track and trace analytical techniques scientists use to detect counterfeits and identifying solutions to the threat of counterfeit medical products. It gives us immense pleasure in welcoming you to “2nd Annual Pharma Packaging, Labelling, Serialisation, Track and Trace 2019".

Tél.: [+91 44 24762472];     Email.: kavitha@virtueinsight.co.in

Healthcare, Packaging, labeling, Anticounterfeiting, Drugregulatory, Serialisation, TrackTrace, Pharmacists, Pharmaceuticals, pharma

American Statistical Association

Statistique, Théorie des jeux,    Pharmacologie et développement des médicaments

Tél.: [02078276000];     Email.: ssapal@smi-online.co.uk

Biosimilar, Biobetters, biologic, generic drug, immunogenicity, innovator, interchangeability, pharmacist, doctors, dosage, legislation, commercialising biosimilars, patent protection

Pharmacologie et développement des médicaments,    Médecine translationnelle, essais cliniques

will bring together top pharmaceutical, biotechnology and regulatory representatives under one roof that will address the key issues of the industry.

Tél.: [+44 2036120886];     Email.: kavitha@virtueinsight.co.in

Pharmacovigilance, DrugSafety, ProductSafety, DrugDevelopment, ClinicalSafety, patientsafety, RiskManagement, regulatoryaffairs

We invite physicians, judges, prosecutors, lawyers, academic members and lecturers, other healthcare professionals and teaching assistants and students in the relevant field to present papers and to participate in our congress. In addition to the main and secondary topics of the congress, presentations can be made on any topic or subject which may have contribution in terms of both practice and theory. During the Congress, there will also be questions and answers sessions and courses running alongside the main programme.

Tél.: [+9005305050666];     Email.: ygdogramaci@yahoo.com

MAIN TOPIC: CONSENT FOR MEDICAL TREATMENT o Consent for Medical Treatment of a Minor Child o Consent for Medical Treatment of an Adult o Possible Exceptions to Consent Requirement for Medical Treatment o Ethical Dilemmas concerning Possible Exceptions to Consent Requirement for Medical Treatment o Presumed Consent o Extension of an Operation o Medical Will o Refusal of Resuscitation under Turkish Law o Problems of Proof and Evidence • THE PRACTICE OF BIOTECHNOLOGY AND LAW o Designer Baby o Assessment of Artificial Intelligence with respect to Medical Law o Stem Cell Research o Human Cloning • ORGAN AND TISSUE TRANSPLANTATION o Amendments with the Law No. 7151 o Harmonisation Activities with the European Union Legislation • ARTIFICIAL INSEMINATION o Human Embryo within Medical Law and Legal Problems o Surrogate Motherhood in light of the Recent Amendments o Consequences of the Amendments with the Law No. 7151 on Artificial Insemination • PRIVACY AND PROTECTION OF PERSONAL DATA o Assessment of E-health Application from the Perspective of Patient Privacy and Personal Data o The Process and Decision of the Personal Data Protection Committee in the field of Medical Law o Problems with Reporting the Pregnancies under the Age of 18 • THE RIGHTS OF HEALTHCARE PROFESSIONALS o Right to Protection against Violence • THE LAW OF MEDICINE AND MEDICAL DEVICES • THE LAW OF HEALTH TOURISM • PALLIATIVE CARE AND MEDICAL LAW CHALLENGES • LEGAL LIABILITY IN PLASTIC SURGERY AND THE CONTRACT OF WORK • EMERGENCY MEDICAL INTERVENTION AND MEDICAL LAW PROBLEMS o Medical Forensic Examinations and Forensic Reports • INTENSIVE CARE AND MEDICAL LAW PROBLEMS • DIALYSIS AND MEDICAL LAW PROBLEMS • LIABILITIES OF PHYSICIANS • THE DETERMINATIONS ON MEDICAL LAW IN THE DECISIONS OF THE INDIVIDUAL APPLICATION TO THE TURKISH CONSTITUTIONAL COURT • CRIME OF GENITAL EXAMINATION • MISDEMEANORS IN THE FIELD OF MEDICAL LAW • THE PRACTICE OF CHEMICAL CASTRATION IN RELATION TO THE RECENT LEGAL DEVELOPMENTS • THE CONCEPT OF PATIENT’S RELATIVE IN MEDICAL LAW • THE PRACTICE OF MEDICAL LAW FROM THE PERSPECTIVE OF SOCIAL GENDER INEQUALITY • PROBLEMS IN PRACTICE ARISING FROM THE HEARINGS OF MEDICAL LAW DISPUTES IN CONSUMER COURTS • ALTERNATIVES TO MALPRACTICE LITIGATION o Mediation o Alternative Models in Comparative Law • LEGAL ASSESSMENT OF DEFENSIVE MEDICAL PRACTICES • END-OF-LIFE DECISIONS • SMART CONTRACTS IN HEALTH TOURISM • LEGAL PROBLEMS WITH FAMILY PHYSICIANS o Liability of Family Physicians Due to the Medical Reports o Liability for The Negligence of Family Physicians in Practice • MEDICAL LIABILITY INSURANCE IN MEDICAL DISPUTES *Please note that congress topics are not limited to the listed ones. We welcome all and any topics related to medical law, in particular, current issues and developments in foreign countries, which bring new insights to the issues concerning medical law.

SOP deficiencies are one of the top 5 findings in FDA audits. The entire Quality Management System (QMS) of an organization could be severely compromised due to SOP defects. Formal written Standard Operating Procedures (SOPs) are required both by the FDA and EMA. Almost every deficiency identified in FDA’s 483s and Warning Letters can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, do not contain important tools to increase compliance with the SOPs and, many times, are hard for the personnel who follow them to understand. They are frequently poorly written, communicated, monitored and enforced. This workshop will provide step by step instructions to create SOPs for FDA-regulated organizations.

Tél.: [+410 501 5777];     Email.: pkumar@fdamap.com

Manufacturing an investigational product for the initial pilot clinical trials could pose a considerable logistical and financial challenge to developers. The first-in-man and pilot clinical trials are usually conducted in very small number of healthy participants with lower doses primarily to establish safety and hence do not need a significant amount of investigational material. The US FDA allows developers to test early stage investigational products under relaxed GMP requirements. The manufacturing requirements for early stage clinical trials are designed to assure adequate quality of the investigational product being tested without the excessive regulatory burden of full-scale GMP manufacturing. This workshop will present the current regulations, guidance documents and regulatory strategies available for manufacturing an early development stage product for Phase I and first-in-man clinical trials. Also discussed will be logistical issues with managing the supply of an early stage investigational product, and requirements for stability testing, storage and shipping, labeling, and documentations. Perspectives for different classes of products will be presented using case studies.

Tél.: [+410 501 5777];     Email.: pkumar@fdamap.com

Regulatory professionals have to write highly technical documents for a variety of audience. These documents include reports, protocols, clinical trial and marketing approval applications, technical reports on studies, and communication documents. This workshop will address best practices, and regulatory strategies on how to write effective documents covering anywhere from simple issues such as minutes of meetings and correspondence notes, to highly sophisticated nonclinical and clinical study reports, and regulatory submissions to FDA, EMA, Health Canada, and other regulators.

Tél.: [+410 501 5777];     Email.: pkumar@fdamap.com

The rising tide of counterfeit medicines are turning into a serious concern around the world, and have progressively been showing up through the real pharmaceutical supply chain, including community and online drug stores.Counterfeit drugs are not only a global public health risk, but also harm the quality of the product, the integrity of the brand, the economy and even national security.We require both countrywide and industry-level participation, and in addition public and private sector coordinated effort, to identify and definitively battle counterfeiters.

Tél.: [02070960786];     Email.: info@corvusglobalevents.com

PharmaSecurityWorld, counterfeitdrugs, Anticounterfeiting, BrandProtection, drugsecuritySerialization, Traceability, SupplyChain, IP, PharmaSupplyChain, Packaging, BrandEnforcement, BrandIntegrity, Labelling, Printing, TrackAndTrace, DrugRegulatory, RFID, fakedrugs