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Documents Essential Documentation GCP Training Seminar 12 th October 2011 Anne Thomas Sister, Dermatology...

Slide 1Essential Documentation GCP Training Seminar 12 th October 2011 Anne Thomas Sister, Dermatology Clinical Research Cardiff University Slide 2 Introduction Essential…

Business Pakistan Clinical Research Capacity

1.Pakistan Clinical Research Capacity 2. PakistanLocated in South Asia, Pakistan shares aneastern border with India and a north-eastern border with China. Iran makes upthe…

Documents Regulatory Challenges In Executing Clinical Trials Globally

1. Regulatory Challenges to Successful GlobalClinical StudiesMichael A. Swit, Esq., Vice PresidentThe Conference Forum 2nd Annual Executing Global Clinical TrialsThursday,…

Documents IND Process and Global Clinical Trials in Korea

1. IND Process andIND Process and Global Clinical Trials in KoreaGlobal Clinical Trials in Korea In-Sook Park, Ph.D Drug Evaluation Department Korea Food and Drug Administration…

Documents The Importance of Standard Operating Procedures (SOPs) in ...

1. The Importance of Standard Operating Procedures (SOPs) in Clinical Trials 2. The Main Objective: • Be a GREAT clinical research site – For the sponsor…

Health & Medicine To compare filing process of NDA of different countries of India, US and Europe. B) Preparation of.....

1. Drug Regulation & Regulatory Authorities Dept. Of Quality Assurance & Regulatory Affairs L. J. Institute of Pharmacy, Ahmedabad. EXPERIMENT NO.: DATE: AIM: A)…

Documents Regulatory Submission Process Clinical Study Application: 1. Submit an appointment...

Slide 1 Regulatory Submission Process  Clinical Study Application: 1. Submit an appointment requestappointment request 2. Fill one of the three templates: - BE / BA study…

Documents Managing Sponsor/Investigator Relationships 5 th National Conference on Managing Legal Risks in...

Slide 1Managing Sponsor/Investigator Relationships 5 th National Conference on Managing Legal Risks in Structuring and Conducting Clinical Trials American Conference Institute…

Documents Pharmacovigilance and Risk Management Chapter 17.

Slide 1 Pharmacovigilance and Risk Management Chapter 17 Slide 2 OBJECTIVES Understand the reporting requirements for Investigational New Drug (IND) safety data Understand…