All NewsBio/Pharma News
All PublicationsPharmTechPharmTech Europe
MarketplaceICH Q9 Revision: A Comprehensive Resource on Quality Risk ManagementPeer-Reviewed ResearchPharmTech ProductsPharma InsightsSponsored PodcastsSponsored VideosSponsored eBooksWhitepapers
Webcasts
All VideosAsk the ExpertBehind The HeadlinesBuy, Sell, HoldDrug Digest VideosDrug Solutions PodcastPeer ExchangeSexy ScienceTech Talk
Conference CoverageConference ListingEvents
Subscribe
AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
Spotlight -
  • Analytics
  • Dosage Forms
  • Drug Development
  • Manufacturing
  • Outsourcing
  • Quality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

AnalyticsAnalyticsAnalytics
Data and Artificial Intelligence
Dosage FormsDosage FormsDosage FormsDosage FormsDosage Forms
Drug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug DevelopmentDrug Development
ManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturingManufacturing
OutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcingOutsourcing
Quality SystemsQuality SystemsQuality SystemsQuality Systems
IS1
  • Applied Clinical Trials

  • BioPharm International

  • Cannabis Science and Technology

  • Chromatography Online

  • Nutritional Outlook

  • Pharmaceutical Commerce

  • Pharmaceutical Executive

  • Pharm Tech

  • Spectroscopy Online

  • Turbo Machinery Magazine

    • Webcasts
    • Subscribe
Advertisement

Evaluating Regulatory Trends Globally and Regionally

October 17, 2019
By Pharmaceutical Technology Editors
News
Article

Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will regulatory tackle trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.

As industry witnessed the highest ever number of new drug approvals by FDA in 2018 and with overall drug evaluations and launches increasing on a global scale thanks to increased R&D productivity, various regulatory trends and evolutions are inevitable. Sarah Hardison, head of Regulatory and Pharmacovigilance Solutions, Clarivate Analytics, will look to tackle these trends in her presentation on the World of Pharma Podium during the second day of CPhI Worldwide.

Global pharma pipelines are becoming more focused on rare diseases and unmet medical needs. As a result of this trend and the various advances in drug technologies, regulatory guidelines have needed to adapt to allow for approvals in cases where there is less evidentiary data.

In her presentation, Hardison will discuss both global and regional trends impacting the regulatory landscape, such as global harmonization, real-world data, next-generation biologics manufacturing, and generics and biosimilars.

Global Regulatory Outlook and Regional TrendsWednesday Nov. 6, 2019 11:00–12:00 World of Pharma Podium (80B10)

Recent Videos
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content

Data technology background. Abstract background. Connecting dots and lines on dark background. 3D rendering. 4k. | Image Credit: © Dmitry

Emerson Unveils AI Platform for Mission-Critical Industrial Applications

Christopher Cole
May 22nd 2025
Article

Emerson’s purpose-built industrial AI solutions are meant to enhance accessibility and reliability, enabling manufacturers to maximize efficiency and performance from automation systems.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


·Mirai Bio and Thermo Fisher are partnering to integrate design, delivery, and CGMP manufacturing for nucleic acid-based therapeutics.  ·The collaboration will leverage Thermo Fisher’s RNA and advanced formulations facility to support scalable development of genetic medicines.  ·Mirai’s machine intelligence platform will be combined with Thermo Fisher’s technical and manufacturing expertise to streamline drug development workflows.

Mirai Bio and Thermo Fisher Partner to Advance Genetic Medicine Manufacturing

Christopher Cole
May 21st 2025
Article

Mirai Bio and Thermo Fisher partner to integrate AI-driven design with CGMP manufacturing, aiming to streamline development of genetic medicines.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Abnormal plasma cell or b-cell in multiple myeloma emitting paraprotein 3d illustration | Image Credit: © LASZLO - stock.adobe.com

CellCentric Completes $120 Million Series C Funding Round for Multiple Myeloma Treatment Inobrodib

Patrick Lavery
May 21st 2025
Article

Inobrodib is being developed as a first-in-class oral cancer drug that the company says will be able to treat not only multiple myeloma, but other specific cancers as well.


A group of antibiotic pill capsules falling. Healthcare and medical 3D illustration background | Image Credit: © James Thew - stock.adobe.com

Personalised Capsule Machine Unveiled by ACG

Christopher Cole
May 20th 2025
Article

ACG partnered with Art of You to launch the world-first Personalised Capsule Machine, enabling on-demand, customized supplement capsules based on individual health data.

Related Content

Data technology background. Abstract background. Connecting dots and lines on dark background. 3D rendering. 4k. | Image Credit: © Dmitry

Emerson Unveils AI Platform for Mission-Critical Industrial Applications

Christopher Cole
May 22nd 2025
Article

Emerson’s purpose-built industrial AI solutions are meant to enhance accessibility and reliability, enabling manufacturers to maximize efficiency and performance from automation systems.


Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.


·Mirai Bio and Thermo Fisher are partnering to integrate design, delivery, and CGMP manufacturing for nucleic acid-based therapeutics.  ·The collaboration will leverage Thermo Fisher’s RNA and advanced formulations facility to support scalable development of genetic medicines.  ·Mirai’s machine intelligence platform will be combined with Thermo Fisher’s technical and manufacturing expertise to streamline drug development workflows.

Mirai Bio and Thermo Fisher Partner to Advance Genetic Medicine Manufacturing

Christopher Cole
May 21st 2025
Article

Mirai Bio and Thermo Fisher partner to integrate AI-driven design with CGMP manufacturing, aiming to streamline development of genetic medicines.


Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.


Abnormal plasma cell or b-cell in multiple myeloma emitting paraprotein 3d illustration | Image Credit: © LASZLO - stock.adobe.com

CellCentric Completes $120 Million Series C Funding Round for Multiple Myeloma Treatment Inobrodib

Patrick Lavery
May 21st 2025
Article

Inobrodib is being developed as a first-in-class oral cancer drug that the company says will be able to treat not only multiple myeloma, but other specific cancers as well.


A group of antibiotic pill capsules falling. Healthcare and medical 3D illustration background | Image Credit: © James Thew - stock.adobe.com

Personalised Capsule Machine Unveiled by ACG

Christopher Cole
May 20th 2025
Article

ACG partnered with Art of You to launch the world-first Personalised Capsule Machine, enabling on-demand, customized supplement capsules based on individual health data.

About Us
Advertise
Contact Us
Editorial Info
Editorial Advisory Board
Do Not Sell My Personal Information
Privacy Policy
Terms and Conditions
Contact Info

2 Commerce Drive
Cranbury, NJ 08512

609-716-7777

© 2025 MJH Life Sciences

All rights reserved.