eRegulatory Summit 2021

  • Apr 2021 (Not Final)
  • Location is not final


eRegulatory Summit 2021 is a conference that covers topics such as:

  • Regulatory feedback, advice and updates from 7 EU and international regulatory agencies
  • EU telematics initiatives, including EMA Gateway, EU eSubmissions Roadmap, eAF, CESP and eSignatures
  • The state of cloud computing solutions and their suitability for regulatory publishing teams
  • The new eCTD validation criteria v5.0 and NeeS validation criteria v4.0
  • How eCTD is being globalised and the current status in
  • Regulatory feedback and advice on eSubmission archiving from Fimea
  • Practical case study insight into the conversion of legacy dossiers to eCTD, supporting emerging market submissions and managing international operations teams
  • Saudi Arabia, ASEAN, Australia and South Africa
  • Benchmarking opportunities including efficient MRP and DCP submission strategies

eRegulatory Summit 2021 brings together Senior Managers, Heads, Publishers, Managers and specialists from pharma, biotech and generics companies involved in:

  • Submissions
  • Regulatory operations
  • Regulatory affairs
  • Publishing
  • Dossier submissions & management
  • Regulatory Information
  • Document management

eCTD - Electronic Common Technical Document

eRegulatory Summit 2021 might be held in Apr 2021 (Not Final).

More Details

1450-2900 Pound Sterling
No exhibition
Informa Connect

Future Events

  • eRegulatory Summit 2021 - Apr 2021 (22016)

Past Events

  • eRegulatory Summit 2020 - 21-23 Apr 2020, Hotel Palace Berlin, Berlin, Germany (22015)
  • eRegulatory Summit 2019 - 08-10 Apr 2019, Crowne Plaza Barcelona - Fira Center, Barcelona, Spain (10876)
  • eRegulatory Summit 2018 - 24-26 Apr 2018, SANA Lisboa, Lisbon, Portugal (41271)


Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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