home > 전문가 컨설팅> 온라인 컨설팅서비스> 컨설팅 신청
프린트
전체 255건, 현재 페이지 13/26
GPKOL
인허가
요르단
- Regulatory submissions & approval : Gained good experience in CTD files for originator & generic drugs, post approval changes, bioequivalence studies ,PSUR. : Manufacturing sites accreditations. : Implementation of Local and international guidance
GMP
- QA and QC of Drugs : Responsible for designing and consultations of many pharmaceutical and nutraceutical industries - RA : Consultant for JFDA for regulatory affairs - Pharmaceutical industries Audit : Accredited inspector for JFDA - Pharmaceutical industries : Formulas development and Method of Analysis development
- Good Manufacturing Practice(GMP) - Regulatory Affairs(RA)
- Following up the drug’s safety information and pharmacovigilance regulations at the international authorities..US.FDA,EMA,TGA,WHO and taking the suitable recommendations. : Training the Health Care Providers on the Concepts of Pharmacovigilance science and adverse drug reaction reporting. : Coordinate with the UPPSALA Monitoring Center /Sweden through reporting the CIOMS forms received from Jordan and hence receiving their updates. : Sharing in establishing the “Good Pharmacovigilance Practice in Arab countries”(GVP). : Assure implementation of (GVP) in Jordan through conducting trainings for preparation of Pharmacovigilance Master File, Pharmacovigilance Subsystem File and perform inspections. : Assessment of drugs Risk Management Plans and Periodic Safety Update Reports submitted upon registration and re-registration. : Analysis of collected safety data from adverse drug reactions and make recommendations. : Regular review and issuance approval of drugs Summary of Product Characteristics and Patient information Leaflets. : Review and update of Jordan Rational Drug List.
- Registration pharmacist : Receiving,evaluating,approving of ctd files : Receiving,evaluating ,approving any change on the product files (post approval changes (pac) : Receiving , evaluating and approving of medical device products : Receiving , evaluating and approving of cosmetic produts : Read of the technical committee for vitamin registration : Rember of the technical committee for new drug
R & D기획
미국
- R&D 기획 - Biopharm : Commercial scale cell line development in E.coli, Yeast and CHO cells : Early stage of upstream process development
- Biomedical Engineering : Tissue Engineering & Regenerative Medicine : 3D printing/3D Scaffold Tissue Engineering for carillage bone regeneration Biomaterials & Cell therapy/delivery for intervertebral disc(IVD) : Regeneration /degeneration/ herniation : Bioprinting of 3D in vitro skin for drug screening : Organ-on-a chip - Complex In Vitro Plattforms / Technology : Project development / R&D planning / technology analysis
- R&D 기획 : Small Molecule Discovery in Research
임상
- Clinical Trial : Biostatistics in Clinical Trial, Clinical Development plan, and Study Design for drug approval from the perspectives of both pharmaceutical industry and HA. - Multiple Comparisons : Commonly used in clinical trials including Gatekeeping, Hochberg, Dunnette, etc. - Adaptive Design : Practical usage of adaptive design
- R&D 기획 - Preclinical development for IND - Clinical development through phase Ⅰ and phaseⅡa, clinical study as a proof of concept and validation of preclinical data. - Non-clinical development (safety/toxicology, ADME/pk, PK/PD, DDI)
