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DESCRIPTION:China’s Life Sciences Compliance webinar will discuss the regu
 latory structure and requirements for compliance against China’s NMPA reg
 ulations for Pharmaceuticals\, Medical Devices\, Biologics and Combinatio
 n Products.\n\nWhy Should You Attend:\n\nChina has been improving its’ re
 gulatory regime governing the food and pharmaceutical industry in recent 
 years. By promulgating the amended GMP and amending GLP\, GCP\, GSP and o
 ther regulations\, China will further align the country with internationa
 l standards of practice. For manufacturers and distributors of drugs and 
 medical devices in China\, as well as importers\, it will be important to
  pay close attention to the pace at which NMPA implements these changes.\
 n\nThis course specifically focuses on the overall regulatory compliance 
 requirements and procedures for Pharmaceuticals\, Medical Devices\, Biolo
 gics and Combination Products in China. The course will cover topics rela
 ting to pre-clinical and clinical requirements\, as well as\, addressing 
 the structure of the regulatory agencies in China. Content will also incl
 ude descriptions of the methods by which regulators in the NMPA process f
 ilings and registrations and what is expected in the authorization and do
 ssier maintenance of licensed products.\n\nLearning Objectives:\n\nThis w
 ebinar is designed to provide an overview of the regulatory requirements\
 , local challenges and important cultural aspects of working with the lif
 ecycle of Life Science Products (pharmaceuticals\, medical devices\, biol
 ogics\, combination products) as an importer into China. It will provide 
 training on:\n\n\nThe Regulatory Structure in China.\nUnderstanding the s
 pecific procedures for Pharmaceuticals\, Medical Devices\, Biologics and 
 Combination Products.\nHow to begin your company's involvement in China: 
 local licenses\, personnel and facilities required?\nClinical Trials: Why
  China? NMPA’s requirements\, the Application Process\, CRO Selection and
  Start-up.\nThe current key regulations effecting product development and
  your company's product pipeline.\nPricing establishment.\nUnderstanding 
 the local concerns and specific challenges in working with Chinese Regula
 tory Personnel.\nUnderstanding the Local Culture: Realistic expectations\
 , timing on reviews\, effective strategies for adding China to your compa
 ny's global market presence.\nInformation necessary for effective dossier
  preparation and how does one take an already approved CTD dossier and tu
 rn it into an acceptable submission package.\nStrategies for streamlining
  the registration application process for faster approval.\nMaintenance o
 f Authorized Products: Variations &amp\; Amendments to Licenses\n\nAreas 
 Covered in the Webinar:\n\n\nCountry Profile / Healthcare System.\nKey Co
 untry Information.\nStrategic Considerations: Why China? / Asia Structure
  / Hub Locations.\nGovernmental &amp\; Regulatory Authorities / Agencies 
 / Structure.\nCompany Establishment\; Licenses &amp\; Key Personnel.\nPar
 tner Companies / Local Relationship Options.\nIn-Country Operational Cons
 iderations\; Importance of Local Distributors.\nRequirements to Conduct C
 linical trials / Approvals / GCP.\nLicensing Products (Innovative Drugs\,
  Generics / Similars\, Orphan Drugs\, Biologics / Vaccines\, Medical Devi
 ces).\nVariations and Amendments to Licenses.\nGMP and Inspections.\nPack
 aging and Labeling.\nPrice Establishment.\nReimbursement.\nImport / Expor
 t / Customs Clearance.\nTaxes / Duties.\nAdvertising &amp\; Promotion.\nV
 igilance Reporting / Post-Marketing Requirements.\nPatents &amp\; Tradema
 rks.\nLocal Customs / Cultural Issues / Establishing Business Relationshi
 ps.\nWorking with Local Agencies / Authorities.\nConclusions.\n\nWho Will
  Benefit:\n\nThis course will be beneficial to:\n\n\nRegulatory\, Quality
 \, Manufacturing\, Global Business Development and General Management per
 sonnel whose responsibilities require knowledge of China’s regulatory\, q
 uality and import / export requirements.\nAdministrative staff responsibl
 e for ensuring compliance with regulatory filings and overall GCP\, GMP a
 nd GLP compliance requirements.\nGlobal business development and general 
 management requiring an understanding of how regulations and compliance i
 ssues are culturally handled along with how best to consider China into o
 ne’s Global Business Strategy.\n
DTEND:20250310T113000
DTSTAMP:20260512T232941Z
DTSTART:20250310T100000
LOCATION:\,
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SUMMARY:China’s Life Sciences Compliance webinar will discuss the regulato
 ry structure and requirements for compliance against China’s NMPA regulat
 ions for...
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