Already a DIA Member? Sign in. Not a member? Join.

Sign in

Forgot User ID? or Forgot Password?

Not a Member?

Create Account and Join

Virtual

Apr 05, 2022 2:00 PM - Apr 08, 2022 6:30 PM

(Central Europe Standard Time)

EMA Clinical Trials Information System - Sponsor user training programme

Demonstrations and explanations of the system functionalities including initial application, RFIs, submitting a modification, search and download options etc.

Faculty

Calin A. Lungu, MD

Calin A. Lungu, MD

CEO, Drug Development Consulting Services S.A. (DDCS), Luxembourg

Dr. Lungu has over 30 years’ experience in drug development, clinical research, Pharmacovigilance and quality assurance. He conducted more than 160 Pharmacovigilance quality system audits in more than 40 countries around the globe. Apart of audits, he is a dedicated trainer of the official EMA EudraVigilance and XEVMPD training programmes and led over 300 offerings since 2004.

Jose Alberto Ayala  Ortiz, MPharm, MSc

Jose Alberto Ayala Ortiz, MPharm, MSc

QPPV, PVpharm, Spain

José is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and electronic transmissions. He has been training EVWeb and XEVMPD training courses since 2004, and collaborates in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies.

Ruediger  Pankow, DrSc

Ruediger Pankow, DrSc

Clinical Regulatory Affairs Expert, CTIS SME, Independent Consultant, Germany

Ruediger Pankow holds a university degree in Biology and is a Regulatory Affairs professional with more than 17 years of experience in the clinical research and trials regulatory space, mostly in the CRO industry. His specific area of expertise is the EU Clinical Trials Regulation 536/2014 (EU CTR) and EU CTR implementation at industry level, including for his past employer Parexel. Since 2019 he has been continuously involved for ACRO as an industry stakeholders' representative (sponsor product owner / external SME) in EMA's Clinical Trial Information System (CTIS) delivery project, and is DIA instructor of EMA's CTIS sponsor end user training programme.

Have an account?

Be informed and stay engaged.

Don't miss an opportunity - join our mailing list to stay up to date on DIA insights and events.