Regulatory Compliance Featured Articles

1. Are Regulatory Agencies Prepared For A Rapidly Aging Population?
   12/10/2018

   Despite changing demographics in aging populations, regulatory guidance specific to drug development for geriatrics has been limited, with guidances dating back to the 1990s.

2. Data Integrity, Startups, & Cloud Storage: Don’t Let This Happen To You!
   12/5/2018

   Data integrity is of paramount importance to ensure patient health and safety and to improve shareholder value, particularly for virtual companies. Startups finding themselves in the throes of managing complex drug development programs realize they may face great risk if they do not begin with the end in mind and integrate data integrity practices early on.

3. Are You Under-Using And Under-Investing In Your Most Valuable Resource?
   10/23/2018

   Larger pharma organization have evolved into hierarchical silos due to a combination of legacy organizational structures, mergers and acquisitions, and lack of a holisitic approach to innovation.

4. Why Invest In Emerging Markets Now
   10/10/2018

   Unexplored and emerging markets are an attractive prospect for biopharma companies looking to expand. But when it comes to ensuring success, what’s the wisest way to invest?

5. How FDA, Industry, And Academia Are Guiding AI Development In Biopharma
   9/28/2018

   Continuously learning systems (CLS) are artificial intelligence (AI) algorithms that constantly and automatically update themselves as they recognize patterns and behaviors from real-world data — enabling companies to become predictive, rather than reactive, with quality assurance. 

6. EMA’s Revised Format For Risk Management Plans: What You Need To Know
   9/17/2018

   The revised format for the EU Risk Management Plan (RMP) sets a new milestone in a progressive approach to risk management. The new RMP template can be used by RMP experts.

7. Brexit: The Good, The Bad, And The Chaos
   8/22/2018

   With just over half a year to go until the divorce date, and roughly two months until European Chief Brexit Negotiator Michel Barnier’s self-imposed October deadline for a Brexit deal, it has started to feel like we are finally seeing some concrete progress when it comes to Brexit.

8. FDA And Quality Metrics: Where Do Things (Currently) Stand?
   7/27/2018

   Are you ready to give the FDA more?  “What?” you ask, as a manufacturer of API and finished goods. Are you ready to give them more data and information about your manufacturing process? You think, “Don’t they get all the necessary information from me during their inspections and from my filings?” Well, the answer is yes and no. 

9. How FDA And MHRA Decide Which Drug Facilities To Inspect — And How Often
   7/13/2018

   The FDA recently revamped the methods it uses to determine which foreign and domestic drug manufacturing sites warrant inspection or other types of surveillance and at what frequency. 

10. Elemental Impurities: Steering Clear Of The Big Four
    7/2/2018

    With new regulations having established a need for the testing of certain elements, correct sample preparation is crucial.