Dr. Adela Gigea, Mba Email & Phone Number

Berlin, De

Berlin, Germany

Berlin, Berlin, Germany

Berlin, Berlin, Germany

Berlin Area, Germany

Cluj-Napoca, Romania

Berlin Area, Germany

• Submission to Ethics Committee• Communication with the Sponsor, the Study Team and other PAREXEL departments • Preparation and compilation of the ISF and TMF including eTMF• Participation in internal and external meetings on different Phase I studies• Reporting of study status directly to Sponsor

Oranienburg Bei Berlin

• Handled internal and external regulatory requests• Prepared regulatory documents according to international guidelines (eCTD-format)• Supervised Regulatory Compliance with regard to client-relevant aspects• Handled Change Control requests• Maintained the Quality Management System

Berlin Area, Germany

• Managed the medical-scientific drug portfolio content as headquarter for 28 countries for thyroid gland, neurology and gout products • Prepared and actualized SmPCs, PILs, IMUs, and labeling texts according to the current PSURs, QRD templates, and deficiency letters from the Authorities • Developed and evaluated training manuals and master folders• Due diligence and evaluation of CTDs for licensing new products

Berlin Area, Germany

Cluj-Napoca, Romania

• Prepared dossiers for clinical bioequivalence studies: protocols, study design, investigators brochures, variations, final reports, and randomization lists• Submitted study dossiers to the Ethics Committee and the National Medicines Agency;• Monitored activities such as CRFs and investigator’s files• Statistical and pharmacokinetic analysis of data

Mba, Biotechmed

Entrepreneurship, Controlling, Finance, Management Skills, Business Law, Patent Management, Supply Change Management, Business Process.

Clinical Monitoring / Clinical Trial Management

3 months training: Theory and practice of conducting clinical trials (Monitoring): • Regulatory Affairs • Theory and practice of clinical.

Phd Student, Pharmaceutical Technology, Bioadhesive Drugs

Master Of International Management In German, Finance, Management, Business Project Management, International Trade

Master Of Drug Analysis And Drug Control, Toxicology, Drug Control, Legislation, Pharmaceutical Technology

Pharmacist, Toxicology, Drug Control, Pharmaceutical Technology, Legislation, Pharmacognosy, Ethics

Activities and Societies: Pharmacy students organisation

Student Of Pharmacy, Pharmacutical Chemestry, Hydrology, Biochemstry, Galenics