Training "New requirements for pharmaceuticals
registration."

 

 

Registration

(More information about program (russian version) at http://www.nbscience.com/sphc.html )

Invited Trainers:

 

 

 

1) Dr.Markov I.,NBScience International

 

2) Dr.Kholin V.,International BioPharmaceutical Association

 

 

3 ) Dr. Malgorzata Brodzka-Raszek,MBR Consulting S.C., Poland


4) A.Szalczyk "Associated Medical" ,Poland

 

5) Dr.Zadorin Eugene, PhD, MBA
International BioPharmaceutical Association,
former head of consulting Group of the Department of Clinical Research of State Pharmacological Center of MOH of Ukraine

( 2006-2008 ).


Who Should Attend
This course is directed to personnel involved in:

  • New Pharmaceutical Product Development
  • Pre-clinical and Clinical Research
  • Regulatory Affairs
  • Quality Assurance

Participants should have an understanding of the steps in new product development and/or the responsibilities of regulatory affairs in submitting new product applications worldwide and local.

Description
The content of this course is to present detailed components of INDs/NDAs, BLAs, ANDAs, SNDAs, IMPDs and CTDs (Modules 1–5). These regulatory submissions will be based on the requirements of the European and Ukrainian Regulations, EU Directives and ICH guidelines. Each of these regulatory documents will be presented as they are related to safety, quality and efficacy necessary for global submissions. Details of non and pre-clinical data, clinical data, and CMC data necessary to achieve new product approvals globally will be presented and discussed. Recommendations for expediting new product approvals will be correlated with the regulatory procedures.

Other topics presented that will help participants understand the structure and bureaucratic demands will include:

• SPhC,EMEA internal structure, policies and procedures
• Regulation requirements for new product submissions
  including SNDAs, CTDs and DMFs globally and local.
• Acceptance of international data for use in new product
  approvals
• Similarities between EU directives and SPhC(Ukraine)

 

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