Pharmaceutical Regulatory Affairs Summit


The pharmaceutical industry is being under continuous pressure and ever-changing now more than ever. For those in regulatory affairs, there are numerous challenges as they plan their regulatory strategy. The current pandemic situation has shown that there is a need for improved collaboration not only with regulatory agencies, but also among pharmaceutical companies. Why do regulatory professionals have such a critical role? How does new European pharmaceutical strategy affect regulatory operations? And how can medical products and devices stay up to date in the age of advancing information technology?

The Pharmaceutical Regulatory Affairs Summit has been designed to introduce new challenges and opportunities of the European pharmaceutical strategy, share light on trends in data management for regulations processes, discuss the role of regulatory affairs, responsibilities of regulatory agencies, regulations of medical devices or upcoming future pharma legislations and much more. This event will provide you with valuable information and strategic visions from representatives of leading companies of the pharmaceutical market.

This business meeting is an excellent opportunity for valuable networking, ideas exchange and a place to gain inspiration from senior-level decision-makers. Learn, share and establish important business contacts with other regulatory professionals.

Join us and register today

Stay on top of the latest trends

Key speakers

Frederic <br><b>IVANOW</b>

Frederic
IVANOW

Head of Global Regulatory Intelligence & Policy
Dr. Anne Silke <br><b>HAMMERBACHER</b>

Dr. Anne Silke
HAMMERBACHER

Director, Regulatory Strategy
Figen Kabadas <br><b>OGE</b>

Figen Kabadas
OGE

Head of Regulatory Affairs
Dr. Anirban <br><b>SADHU</b>

Dr. Anirban
SADHU

Director, Regulatory Affairs (Emerging Markets)
Helen <br><b>SHENNAN</b>

Helen
SHENNAN

Regulatory Affairs Director
Alex <br><b>SCHENK</b>

Alex
SCHENK

Head ERC Customer and Technology Solutions


Key topics

  • Challenges and opportunities of EU pharmaceutical strategy
  • Use of AI in Regulatory Strategy
  • Regulatory agencies – The approval processes
  • Data validation in regulatory submission
  • Directives and regulations on medical devices
  • Regulatory documentations for APIs
  • Regulatory affairs profession: Evolution, responsibilities and career paths
  • Getting medicines to patients faster
  • Models of regulatory collaboration



Who Should Attend

Members of board, C-level, Senior/Global Vice Presidents, Directors, Heads of departments from pharmaceutical industry involved in:

  • Regulatory Affairs
  • Regulatory Intelligence
  • Regulatory Policy
  • Regulatory Compliance
  • Regulatory Operations
  • Regulatory Project Management
  • Regulatory Information Management
  • Regulatory Devices
  • Regulatory Strategy
  • Regulatory Submission
  • Regulatory Sciences
  • Regulatory Documentation
  • Regulatory Labelling
  • Regulatory Development
  • Data Collection
  • Data Management
  • Lifecycle Management