TGA Australia

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