Fast program of the Second International Week on Regulatory Science and Good Regulatory Practices

Transcription

1 Fast program of e Second nternational Week on Regulatory Science and Good Regulatory Practices on Regulatory Science 1 Heal and regulatory affairs specialists from all around e world will meet from e 27 to 29, November 2018 at Centro Citibanamex, Mexico City to hear and share updates and experiences about current and future global heal reats, e role of Regulatory Science and Good Regulatory Practices in achieving Universal Healcare Coverage rough innovation, regulatory harmonization and convergence, dissemination and use of international recognized standards, learning, training and experience gaering in regulation and heal practices. OBJECTES Experience sharing on regulatory harmonization and convergence. Foster e Regulatory Science and Good Regulatory Practices from oer countries and from regional and international regulatory networks. Encourage e access to safer, more effective and high quality healcare products and services for e population, as well as promote of heal and prevention of diseases. Enhance e cooperation and dissemination on Regulatory Science and Good Regulatory Practices for e benefit of new products & healcare technologies rough innovation of new erapies or related technologies, by improving e regulatory framework. TOPCS TO ADDRESS 1. Emerging global reats for heal. 2. Regulatory science and its contribution to heal. 3. Harmonization, convergence, reliance and international standards. 4. Regulatory policy and good regulatory practices. 5. Professional competencies for regulatory professionals. SGN UP HERE

2 2 Second nternational Week Centro Citibanamex, CDMX. november 27-29, 2018 Common forum Medicines forum Medical devices forum Emerging global reats for heal Regulatory science and its contribution to heal Harmonization, convergence, reliance and international standards Regulatory policy and good regulatory practices Professional competencies for regulatory professionals DAY1. november 27, :30 / 10:00 Registration 10:00 / 11:00 nauguration 11:00 / 12:00 Coffee break, press conference and Campaign Launch: Antimicrobial Resistance TME TOPC SUBJECT NSTTUTON 12:00 / 12:30 The antimicrobial resistance as an emerging reat for heal Centers for Disease Control and Prevention (CDC) nnovation, sustainable access and rational use of antimicrobials and awareness platforms for e use of antibiotics Pan American Heal Organization and e World Heal Organization (PAHO / WHO) Mexico 13:00 / 14:00 Current challenges in e fight against Antimicrobial Resistance. Difficulties in e implementation of e National Strategy UNAM, SENASCA, CONAGUA, COFE- PRS, PAHO/WHO, BECTON DCKN- SON and PFZER MEAL 14:00 / 15:00 15:00 / 15:30 Action plan on antimicrobial resistance in Mexico COFEPRS (NRA Mexico) 15:30 / 16:00 Trends in Biopharmaceutical manufacturing; Regulatory Review -US & EU Merck Life Science 16:00 / 16:30 US FDA experience in regulatory science US FDA (NRA USA) ntroduction to e Global Regulatory Convergence of Medical 15:00 / 15:30 Abbott Devices 15:30 / 16:00 nternational Standards and eir adoption in Regulatory models Becton Dickinson

3 on Regulatory Science 3 TME TOPC SUBECT NSTTUTON 16:00 / 17:00 Safety of heal professionals and patients when utilizing medical devices and its relation wi NOM-022 and NOM-045 AMEN, National nstitute of Nutrition Sciences, BD and High Specialty Medicine Unit National Medical Center Siglo XX 17:00 / 18:00 The role of e different stakeholders in e implementation of e Action Plan for e control and supervision of e dispensing and sale of antimicrobials Pan American Heal Organization and e World Heal Organization (PAHO / WHO) Mexico DAY 2: november 28, :30 / 09:00 Substandard and falsified medical products as a global reat to heal nternational Federation of Pharmaceutical Manufacturers & Associations (FP- MA) 09:00 / 09:30 Supply chain systems in Latin America Pan American Heal Organization and e World Heal Organization (PAHO / WHO) Mexico Traceability and serialization of medicines: 09:30 / 10:00 COFEPRS (NRA Mexico) Challenges and perspectives. 10:00 / 10:30 Strategy to combat e illegal drug market COFEPRS (NRA Mexico) BREAK 10:30 / 11:00 Registration, control and tools to prevent e 11:00 / 11:30 sale and distribution of counterfeit and substandard Marzam, Funsalud y Ubictum heal products 11:30 / 12:00 Opportunities for improving traceability in supply chain GS1, México systems 12:00 / 12:30 The Medicine We Can Trust Campaign United States Pharmacopeia (USP) Centre of excellence for advanced erapies as a priority of e Medicines & Healcare products Regulatory Agency of United Kingdom (MHRA) National nstitute for Biological Standards and Control (NBSC, UK) 13:00 / 14:00 Advanced erapies in priority and or emerging AMGEN diseases MEAL 14:00 / 15:00

4 4 Second nternational Week DAY 2: november 28, 2018 TME SUBJECT NSTTUTON TOPC 15:00 / 15:30 Critical Quality Attributes (CQA) of biotech medicines National Polytechnic nstitute (PN) Safety Assessment of biotechnological medicines 15:30 / 16:00 La Roche mpact of e NAFTA negotiation on heal services: Perspectives from Mexico 16:00 / 16:30 Gylsa Group 16:30 / 17:00 Excipient and Supplier Qualification and Supply Chain Security from an excipient manufacturer s perspective nternational Pharmaceutical Excipient Council from Americas Region (PEC) 15:00 / 15:30 Medical Devices Single Audit Program (MD- SAP) Becton Dickinson 15:30 / 16:00 Medical Devices Single Audit Program (MD- SAP) Arrow nternacional/teleflex Medical 16:00 / 16:30 Software as a Medical Device Siemens Healineers 16:30 / 17:00 Convergence initiatives in e Americas ANSA (NRA Brazil) 17:00 / 18:00 Chain supply challenges to avoid counterfeit and substandard products To be confirmed DAY 3: november 29, :30 / 09:00 alidation: New trends in LATAM and highlighting e importance of different Merck Life Science tests Storage & Transport - Compliance towards 09:00 / 09:30 Good Distribution Practices Transport Qualification Pfizer 09:30 a 10:00 Audit Management in a GMP Environment Merck Life Science 10:00 / 10:30 Education model and Regulatory Professional Competencies of RAPS USA Regulatory Affairs Professionals Society (RAPS) 10:30 / 11:00 Regulatory Science education model UC Berkeley School of Public Heal BREAK 11:00 / 11:30

5 DAY 3: november 29, 2018 on Regulatory Science 5 TME SUBJECT NSTTUTON TEMA 11:30 / 12:00 Pharmacopeial Harmonization of Excipient Monographs Excipient GMPs and Third Party Certification nternational Pharmaceutical Excipient Council from Americas Region (PEC) 12:00 / 12:30 Regulatory Convergence and Harmonization Sanofi to increase access to medicines Regulatory system in e Russian Federation and e Eurasian Economic Union. Labelling of medicines FS State nstitute of Drugs and Good Practices under Ministry of ndustry and Trade of e Russian Federation SD & GP, Russia RNA) 13:00 / 13:30 nnovatives regulatory paways for medicines registration Centre for nnovation in Regulatory Science (CRS) 13:30 / 14:00 Evaluation of e regulatory policies and functions of a national regulatory agency State Center for e Control of medicines, medical equipment and devices (CECMED NRA Cuba) 11:30 / 12:00 Comparative analysis of e national standard for medical device labeling and international best practices COFEPRS (NRA Mexico) 12:00 / 12:30 nfluence of technosurveillance in e post-design and post-marketing stages for e registration of new products COFEPRS (NRA Mexico) Effective risk management in Good Manufacturing Practices COFEPRS (NRA Mexico) Risk management in e implementation of technosurveillance 13:00 / 13:30 in Mexico Biomedical Engineers College Good storage and distribution practices for 13:30 / 14:00 COFEPRS (NRA Mexico) medical devices MEAL 14:00 / 15:00 15:00 / 15:30 Scientific risk-based comparability study design for biological products Global Regulatory Affairs and Clinical Supply Organization (GRACS) / Merck Sharp and Dhome Current challenges in managing post-approval changes 15:30 / 16:00 Sanofi / Merck Sharp and Dohme The UK s experience and model for harmonization, convergence and reliance in e regu- 16:00 / 16:30 Medicines and Healcare products Regulatory Agency (MHRA, UK) lation of heal products

6 6 Second nternational Week DAY 3: november 29, 2018 TME SUBJECT NSTTUTON TOPC 16:30 / 17:00 The evolution of e GxP. Challenges and opportunities for training and learning such practices Pharma Quality Europe Group (PQE) 15:00 / 15:30 Reconditioning and remanufacturing of medical devices Siemens Healineers 15:30 / 16:30 Process for e access of medical devices to e public sector. What is done in oer countries? And what is done in Mexico? CANFARMA, COFEPRS, CENETEC, AMD, SPOR The importance of e regulator in e life 16:30 / 17:00 Abbott cycle of e medical device 16:00 / 17:00 Closure