1 Hour and 45 Minute Video | Presented by King & Spalding

 

European legislators are currently working toward the implementation of a harmonized clinical trial regulation, which may directly affect pharmaceutical clinical studies, and indirectly affect medical device clinical studies, taking place in EU member states as early as 2016. The clinical trial regulation, which was endorsed by the European Parliament on April 2, 2014, would override the current clinical trial directive (2001/20/EC) with a simplified, synchronized process for the submission and approval of clinical trial dossiers, as well as provide important new guidelines for the public transparency of clinical study findings. While industry is generally supportive of these initiatives, many regulatory and clinical teams are concerned about the implications the regulation will have on established clinical processes and procedures.

  •     Discussing expectations when migrating from a directive to a regulation
  •     Defining new requirements for clinical results public transparency
  •     Implementing proactive measures to fulfill proposed requirements
  •     Rational and industry comments on potential regulation
  •     Understanding non-compliance consequences and fines
  •     Forecasting next steps and implications for industry and patients

 

Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  •     Regulatory Affairs
  •     Legal Counsel/Affairs
  •     Clinical Affairs & Operations

This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.

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Ulf Grundmann
Partner
King & Spalding

 

Ulf Grundmann is a partner in the Frankfurt office of King & Spalding and a member of the  FDA & Life Sciences practice. He regularly advises household names in the life sciences and food and beverage industries on litigation, intellectual property and unfair competition.


Mr. Grundmann advises European and U.S. clients in the areas of IP and unfair  competition law. He focuses on litigation and arbitration as well as extra-judicial advice. Mr.Grundmann advises clients in the pharmaceutical, medical devices and food industries; focusing on regulatory work for these sectors.

 

 

 

 

 

Beverly H Lorell, MD
Senior Medical and Policy Advisor
King & Spalding

 

Beverly Lorell is the Senior Medical and Policy Advisor with the firm’s FDA & Life Sciences
Practice Group in Washington, D.C. Dr. Lorell specializes in the areas of clinical trial design
of studies for drugs, devices and biologics; review of pre-market submissions; recalls; and
assessment of matters involving a risk to health. She also specializes in the area of physician and industry relations and the development of independent scientific panels to advise health industries.

 

 

 

 

 

Christina M. Markus
Partner
King & Spalding

Chris Markus is a partner in the Washington, D.C. office of King & Spalding and serves as Deputy Chair of the FDA & Life Sciences Group. Her practice focuses on the regulation of drugs, biologics, and other products by the Food and Drug Administration (FDA), the U.S. Drug Enforcement Administration (DEA), and related state agencies (e.g., boards of pharmacy). Ms. Markus represents companies in a range of regulatory compliance, enforcement, and business transactions (e.g., due diligence assessments) involving product development and approval, safety, labeling, marketing and advertising, and supply chain.

 

 

 

 

 

 

Pulina Whitaker
Partner
King & Spalding

 

Pulina Whitaker is a UK qualified lawyer in King & Spalding’s London office. She is a Partner in the London Employment and Benefits Practice.

 

 

 

 

 
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