1. Pink Sheet

Parexel Execs On Regulatory Harmonization, AI Impact, RWE Challenges

Opportunity For RWE In India

 
• By Vibha Ravi

From the US FDA’s ISTAND Program to EU’s Melloddy Initiative, and from the global challenges of real-world data to the opportunities in India, Parexel’s EVP for Clinical Data and Digital Services, chief strategy officer and India head speak on a range of topics in this interview with the Pink Sheet.

L-R - Parexel’s Kushal Gohil (Chief Strategy Officer), Sanjay Vyas (EVP and MD for India) and Stephen Pyke (EVP, Clinical Data and Digital Services) • Source: Pink Sheet/Citeline

In a world where pharmaceutical companies are expanding their commercial footprint across borders and where product pricing is coming in for greater scrutiny on home turf, the role of regulatory harmonization in keeping trial and drug approval costs lower is being closely followed.

The Pink Sheet regularly speaks to industry stakeholders on such issues and recently sat down with executives at Parexel International Corp

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from R&D

More from Pink Sheet

Viatris Agrees To $335m Opioid Settlement Ending US State, Local Government Cases

 
• By Dean Rudge

Viatris joined Hikma and Amneal, in signing agreements for cash settlements that resolve allegations its practices fueled the US’ deadly opioid epidemic.

Pharma Predicts Modest Tariff Impact, Depending On What Comes Next

 
• By Jessica Merrill

Drugmakers are not expecting a big financial hit from tariffs for now, but a report commissioned by the industry trade association PhRMA suggests a potentially steep cost for pharma-sector tariffs.

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.