Regulatory/Legal
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The five IDMP standards and upcoming changes to data submission
September 29 by Leila HawkinsWhat pharma companies need to know about changes to the submission of data for medicinal products
How to navigate UK and EU quality regulations in a post-Brexit world
August 15 by Pharma IQFind out the differences between UK and EU regulatory bodies
Keeping tabs on Covid-19: Taiwan’s vaccine feud with China ends and South Africa registers more than 17,000 new Covid-19 cases
July 16 by Emily UwemedimoThe sharp rise in Covid-19 infections in Taiwan has renewed the debated on whether the island’s government should allow drug imports to resume from mainland China
Anti-counterfeiting playbook for small- and mid-sized pharma companies
June 15 by Pharma IQGain five key implementation strategies for integrating an effective ACP program with this short guidebook from Authentix
FDA grants accelerated approval for first Alzheimer’s disease treatment
June 11 by Emily UwemedimoThe FDA has approved Biogen and Eisai’s Alzheimer’s disease drug aducanumab
A regulatory perspective on real-world data and real-world evidence
April 23 by Sanyam GandhiDive into the thoughts and insights of a regulatory expert at Takeda as he evaluates how two data solutions can support drug development study requirements
Keeping tabs on Covid-19: AstraZeneca hoping to win US approval for their Covid-19 vaccine and J&J resumes its vaccine roll out in Europe
April 23 by Emily UwemedimoWith global demand for the Covid-19 vaccine still uncertain, two big pharma companies look to enhance their vaccination roll out programs in Europe and the US
How to implement an anti-counterfeiting strategy earlier into the drug development process
April 01 by Pharma IQDownload this white paper to find out how small- and mid-sized drug companies can protect themselves against counterfeit medicines
Philippines FDA to speed up Covid-19 clinical trial approval decisions by 50 per cent
February 18 by Emily UwemedimoJanssen among pharma firms being provided increased transparency of regulatory decisions on clinical trial processes in the Philippines
The state of data integrity and data security in life sciences
November 16 by Pharma IQDive into expert-led industry analysis and a solution-driven case study to find out how automation can improve data integrity and security while enhancing the digitization of the life sciences industr...
Patent and know-how licensing: Going beyond the textbooks
December 16 by Charlotte TillettCharlotte Tillett, Partner at Stevens & Bolton LLP, discusses the key concerns of practitioners working with patents and know-how licenses
US Launch: Five litigation strategies European biosimilar developers should know
November 12 by Pharma IQJoshua Whitehill and Natasha Daughtrey, Goodwin, share insight on how European developers can successfully launch a biosimilar in the US