Conférences - Législation en médecine et pharmacologie

This study day aims to explore this novel approach and discuss the challenges inherent in service provision, treatment delivery and the care and management of patient completing CAR-T.

Conference Team;     Tél.: [02078082921];     Email.: conferenceteam@rmh.nhs.uk

Each year FDA receives about 3000 applications for new devices via the 510k process, and about 60% of them are rejected either for poor quality application that cannot even be reviewed or for other technical reasons. Submissions to the FDA that are poorly organized, do not follow current practices, contain inconsistencies between documents, have missing or incomplete content, or poor structure will result in significant delays in the clearance process. With multiple review cycles, up to 90 days each, rejections by FDA could stretch the 510k clearance time-lines to 8 months or more. Most of the refuse-to-accept deficiencies are due to the inexperience of the 510k writers, who ignore the FDA rules. Writing and assembling a complete and well structured 510(k) submission will certainly improve the likelihood of FDA clearance on the first round.

This hands-on workshop is done by one of the industry’s top regulatory expert. The trainer has performed numerous reviews of 510(k) submissions over the last 15 years, and has analyzed the reasons that most often lead to delays in getting submissions ultimately cleared by FDA. This hands-on workshop will walk the attendees through the structure and key elements of the 510(k) submission and explains in clear language the most common pitfalls to avoid in the development of your 510(k) submission to the FDA.

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

FDA 510(k) Approval, 510(k) Clearance, FDA 510(k) Submission, FDA Submissions, 510(k) Application, FDA 510(k) Strategy, FDA Clarence, FDA Approval

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

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

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.