Regulatory Insights

41. MHRA’s Summary Of PV Systems (SPS) Document
    3/26/2013

    As everyone who deals with the EU and the UK in drug safety knows, the EMA issued a new set of Good PV Guidelines to replace (largely) Volume 9A. By Bart Cobert

42. MHRA’s Compliance Report
    3/26/2013

    On February 5, 2013, the MHRA put out an update bulletin on its “Compliance Report”. The Compliance Report from the MHRA began around 2009 when they moved to a risk based pharmacovigilance (PV) inspection process. By Bart Cobert

43. Don’t Take It For Granted
    3/20/2013

    Investigator grant payments are typically the single greatest expense in a clinical trial budget, often accounting for 40 to 60 per cent of the total budget. By Kevin Williams, CFS Clinical

44. CFS Clinical Helps Top 20 Pharma Improve Investigator Payment And Budget Management While Addressing Sunshine & FMV Compliance
    3/19/2013

    Like its peers of all sizes operating in the United States, this Top 20 Pharma has faced the challenge of anticipating and addressing the Physician Payment Sunshine Provision (PPSP) within the Patient Protection and Affordable Care Act (PPACA) of 2009. Presented By Jim DiCesare, VP and General Manager, Contract and Regulatory Services

45. FDA Encourages More Women in Clinical Trials
    3/1/2013

    The FDA issued a draft guidance on the study and evaluation of gender differences in medical device clinical studies. The guidance is issued with hopes to increase the number of female subjects enrolled in clinical trials.

46. Managing Clinical Risk For The Development Of Drugs And Devices
    2/21/2013

    Managing regulatory risk in an environment of increasing regulatory scrutiny is a critical success factor to consistently develop and launch new products efficiently. Organizational regulatory risk management capabilities may become a competitive advantage for all development stages. This report will address the regulatory risk of clinical development through a review of regulatory trends for a period of 18 months.

47. Drug Safety In France & Underreporting Of AEs
    2/12/2013

    There is a lively controversy underway in France right now regarding drug safety. By Bart Cobert

48. Challenges, Prechallenges, Dechallenges And Rechallenges
    2/12/2013

    This is an interesting topic for which several confusing points have arisen and which merits an in depth look. By Bart Cobert

49. Breaking The Blind In Clinical Trials & Reporting To Health Authorities, Investigators & IRBs/Ethics Committees
    2/12/2013

    This is a topic that has caused much consternation in pharmaceutical companies and has, in my experience, caused some clinical trials and even NDAs to fail due to an inadequate number of analyzable patients. By Bart Cobert

50. Improve Investigator Payment and Budget Management While Addressing Sunshine & FMV Compliance
    2/11/2013

    Like its peers of all sizes operating in the United States, this Top 20 Pharma has faced the challenge of anticipating and addressing the Physician Payment Sunshine Provision (PPSP) within the Patient Protection and Affordable Care Act (PPACA) of 2009. By CFS Clinical