TGA Australia

therapeutic goods administration tga presentation medical devices regulatory reforms regulation regulations complementary medicines arcs medicine presentations medical device therapeutic goods advertising medicines pharmacovigilance good manufacturing practice australia training prescription medicine risk medicines regulation post-market sponsor information medicinal cannabis compliance management clinical trials prescription medicines biologicals arcs 2016 plan therapeutic goods legislation inspection program ivds gmp risk management plans medical devices workshop ectd clinical evidence conformity assessment scheduling policy framework pic/s information ebs generic medicines clinical trial notification regulatory guidance manufacturing overview regulatory regulation of medical devices regulatory frameworks evaluation tbs business tga guidance software labelling/packaging permitted indications quality standards mmdr application process adverse events therapeutic goods order guide requirements safety legislation recall webinar advertising complaints handling medicine shortages regulatory requirements international tga compliance ebusiness questions patient education stem cells risk management inspection process manufacturing quality pre-market medicine labels ivd reform cma activities data integrity tissues therapeutic advertising reforms electronic submissions changes cell therapy cells autologous communication faecal microbiota transplantation clinical evaluation reports ctn pilot programme process risk minimisation non-prescription medicines scheduling office of drug control sponsor administrator consultation gmp clearance tgo pharmacopoeias audit assessments monitoring tissue products sme assist minimisation industry therapeutic goods regulation human cellular therapy international harmonisation gmp requirements tga business services rmp evaluating risk guidelines digital medicine labelling application audits prescriptions enterprise listed medicines electronic esubmissions australian specific annex regulatory environment otc artg consumers non recall review submission advertising code adverse reporting periodic safety update reports fees and charges student post-market responsibilities (i) ace post-market responsibilities (ii) ctx unapproved therapeutic goods protein biologics ebusiness services module 3 regulatory convergence australian reflection biological regulation of in vitro diagnostic medical devices clearance goods packaging cell prescription accurate manufacturers evidence post-market vigilance activities quality decision making and reviews biosimilars device registration illegal annual charge exemption dossier annual charges low value turnover committee lbs literature based submissions risk minimisation activities psc packaging advisory shortages msi travelling submitter drafter initiative benefits psur labelling cosmetic injectables pilot microbiology education peptide biosimiars extrapolation indications unapproved manufacture registered food-like legal improvements business services impurities convergence acpm listed forum cooperation monitor postmarket parenteral drug association (australia) consortium conference chemistry toxicology therapeutic innovation australia symposium pe009-13 pathways provisional approval pathways international society of pharmacovigilance market analysis schedule 3 substances poisons standard complaints system supply chain assessed listed medicines device vigilance manufacturing principles international work-sharing pilot tgo 92 regulatory issues tgo93 access schemes minor variation e-form electronic form global penalties sanctions manufactured overseas performance requirements vigilance requirements supply and distribution bioequivalence bioavailability orphan drugs medsearch app pda human cells and tissue regulation 2d datamatrix codes medicnes human cells and tissues good clinical practice biologcal therapies gene therapies regulatory pathways regulatory guidelines methodologies otc medicines consumer medicine information cmi template evidence based pvip international collaboration adverse event management system digital medical devices complementary medicine safety cybersecurity quality risk management systems custom made medical devices registered medicines patient implant cards information leaflets comparable overseas regulators market authorisation evidence global compliance acss consortium health software as a medical device personalised medical devices 3d printed devices unique device identification post market monitoring compliance framework section 19a medical devices/ivds ingredient names legislative framework custom-made regulatory obligations mdsap imdrf igdrp ich international generic drug regulators programme icdra icmra iprf recalls urptg high risk devices international regulation epars australian public assessment reports blood tga expectations manufacturer's evidence identification application measuring effectiveness business improvement program infectious disease contamination control cleaning validation breakthrough therapies online risk minimisation effectiveness national joint replacement registry experience with aoanjrr implant registry data australian orthopaedics association engineers research influenza immunisation epidemiological sponsor responsibilities sponsor roles biovigilance licensing certification nanomedicines nanotherapeutics nanoparticle nanotechnology sunscreens hprg asmi annual conference single use devices tgo 91 generic medicines reform program auspars european public assessment report ema european medicines agency asa odc thc cannabinoids cbd cannabis quality management system qms post-market reviews annual reporting incident reporting on-going monitoring pre-clinical studies public service scientists