Regulatory affairs training

Groupware Training is offering Regulatory Affairs training in Hyderabad with real time faculties. To know more Contact: Mobile: +91-

COVALENT:- Covalent is a group of company which has services and operations in Clinical, Information Technology, Energy, consumer products, Power and Infrastructure. Training @ Covalent:- We arededicated to establish ourselves as ''A values-driven organization''. These values will continue to direct our growth and organization’s operation. “Covalent” values supporting the way like “Kreative”. Regulatory Affairs(RA) Training or Course:- Introduction to different types of Pharmaceutical products: Basic concepts on Rx, OTC, API, Starting material, DP/FP, Generics vs. Innovator drugs, Biologics vs. Biosimilars, Laws vs. Regulations vs. guidelines. Drug discovery and development Worldwide regulatory agencies and their role Approval process for each of the below products in US/EU/India: [covers development path, submissions, regulatory expectation for development, approval and market] Post-market regulatory obligations GLP’s: 21 CFR 58 -The History of GLP, The Idea behind GLP, The Areas of Application, The Pillars of Good Laboratory Practice, Where Can GLP be Profitably Applied?, Indian GLP and International GLP. CMC topics: GMP (US/EU/Indian/ PIC), Preformulation studies (Drugs and Generics), ICH Q 7 guideline, 21 CFR 210 and 211, Medical device CE marking and ISO certifications. Audits, pre and post approval Inspections, handling post inspection/ audit queries. Collecting, organizing and compiling various regulatory submissions in compliance with the applicable regulations: ASEAN and BRIC regulations and registration process of Drugs and Biologics. Different stages of interactions, briefing packages, responses and corrective measures during drug approval process with FDA. PDUFA meetings and advisory committee meetings with US FDA, EU scientific advisory committee. Regulations of Drugs and cosmetics Act, and its importance to Indian pharma industry. Recent regulatory changes in Indian DCGI and compiling dossiers for various DCGI submission: Hands on workshops in next 15 days: Word template of CTD structure. Hands on work of filling different regulatory forms in US/EU/India. Preparing for Regulatory interviews (Example interview questions will be provided). Communication skills. 2-3 seminars each of individual students to enhance their confidence and presentation skills. Explaining the real difficulties faced in a pharma industry and providing Corrective and Preventive Actions (CAPA). Training Duration (Classroom/Online): 3-Months/2-Months Training Fee: 20K/25k + Taxes Mobile: Website:- http://covalentech.com/regulatory_affairs.html

Covalent is one of the leading training institutes for Regulatory Affairs in Hyderabad.Course Content of RA is Introduction to different types of Pharmaceutical products: Basic concepts on Rx, OTC, API, Starting material, DP/FP,Biologics vs. Biosimilars, Laws vs. Regulations vs. guidelines. Worldwide regulatory agencies and their role Approval process. Post-market regulatory obligations GLP’s: 21 CFR 58 -The History of GLP, The Idea behind GLP, The Areas of Application, The Pillars of Good Laboratory Practice,,Indian GLP and International GLP. CMC topics: GMP, Preformulation studies, ICH Q 7 guideline, 21 CFR 210 and 211, Medical device CE marking and ISO certifications.

COVALENT:- Covalent is a group of company which has services and operations in Clinical, Information Technology, Energy, consumer products, Power and Infrastructure. Training @ Covalent:- We arededicated to establish ourselves as ''A values-driven organization''. These values will continue to direct our growth and organization’s operation. “Covalent” values supporting the way like “Kreative”. Training Duration (Classroom/Online): 3-Months/2-Months Training Fee: 20K/25k + Taxes Mobile: Website:- http://covalentech.com/regulatory_affairs.html

Type Distance learning courses PG Diploma in Drug Regulatory Affairs from NIMS University Distance Education The pharmaceutical, biotechnology and medical device research and development industries are among the most highly regulated industries globally. As pharmaceutical sector is growing rapidly, there is a need of regulatory affairs professionals to cater the current needs of industries for the global competition. Regulatory affairs professionals are the link between pharmaceutical industries and worldwide regulatory agencies. Pharmaceutical Industry, being one of the highly regulated industries, is in immense need of people than ever before who are capable of handling issues related to regulatory affairs in a comprehensive manner. Program Code best PGDDRA PGDDRA Duration Min. Duration 1 Years Max. Duration 3 Years Eligibility Criteria Graduate in Science Stream Tution Fees per annum / After the completion of PGDDRA, you will find a challenging career in a hospital and healthcare industry Common job profiles of students after completing PGDDRA include: Medical and Health Services Managers, Hospital Administrator, Manager, Senior Manager, Hospitals and other Senior Leadership Positions.

RAAJ GLOBAL PHARMA REGULATORY AFFAIRS CONSULTANTS [RAAJ GPRAC], Thane-Mumbai is an ISO certified 29990-2010, and NSDC accredited institute for Pharma training and Upskilling.JOBS available with training into Global Regulatory Affairs, QA-QM, Clinical, PV, CTD/eCTD/ACTD/NeeS Regulatory submissions etc. 100% JOB Guarantee. Eligibility- B.Pharm, M.Pharm, B.Sc, M,Sc, B.Tech, M. Tech and Life sciences graduates and Pharma working professionals.

This is a self-study guide for the {ECA Certified Regulatory Affairs Manager} Video Course. It covers all the information that candidates need to know in order to pass this certification examination.

Introduction to different types of Pharmaceutical products: Basic concepts on Rx, OTC, API, Starting material, DP/FP, Generics vs. Innovator drugs, Biologics vs. Biosimilars, Laws vs. Regulations vs. guidelines. Drug discovery and development Worldwide regulatory agencies and their role

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains students with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital.

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains students with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S /B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. ADDRESS: INSTITUTE OF GOOD CLINICAL PRACTICE, # 2ND FLOOR,ABOVE MORE SUPER MARKET, NEAR SRIPURAM COLONY BUS STOP, MOOSARAMBAGH, MALAKPET, HYDERABAD. PH:,, 040 .

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains studentswith hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM,SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room,Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research. Technical learning's: Extensive knowledge of drug safety and drug development process and procedures In-depth knowledge of coding principles, submission criteria, regulatory timeline requirements, technical requirements and guidelines Extensive knowledge of US and ICH safety reporting regulations and guidelines. Good understanding of IND safety reports, 21 CFR part 11 and HIPPA guidelines. Performed triage, evaluation and processing of adverse event reports from post marketing and clinical sources in accordance with FDA and ICH guidelines Working knowledge pertaining to MedDRA and WHO Drug dictionaries. Proficient in data entry and excellent knowledge of ARGUS safety database. Eligibility: Bachelor's, Master’s, or PhD, MBBS/ MD/B.D.S /M.D.S/ B.A.M.S / B.H.M.S/B.P.T/ B.Tech (Biotechnology / Pharmaceutical Science) / B. Pharm /M.Pharm /BVSC / B.Sc. (Nursing) / B.Sc./M.Sc, M.Pharmacy, M.Sc /MA (Statistics) and all professionals working with Pharmaceutical companies, CROs and Hospital. MAIL ID: WEBSITE: www.igcp.co.in FOR ONLINE TIMINGS: PM TO PM FOR CLASS ROOM TIMINGS: AM TO PM ADDRESS: INSTITUTE OF GOOD CLINICAL PRACTICE, # 2ND FLOOR,ABOVE MORE SUPER MARKET, NEAR SRIPURAM COLONY BUS STOP, MOOSARAMBAGH, MALAKPET, HYDERABAD. PH:,, 040 .

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management,CDISC-SDTM, and SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains students with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance,Drug regulatory affairs, Table Listings Figures (TLF’S)etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research.

Institute of Good Clinical Practice (iGCP) offers different unique programs for aspiring professionals willing to pursue a career in Clinical Research, Clinical Data Management, CDISC-SDTM, SAS. The training program aims to provide a career path for professionals from Life Sciences and Statistics background. Highly experienced staffs from clinical research and data management industry trains you with hands on experience on various areas in clinical research, Clinical Data Management, CDISC-SDTM, SAS, Pharmacovigilance, Drug regulatory affairs,etc. Institute of Good Clinical Practice (iGCP) provide training in three different modes like Class Room, Online-learning for all Medical, Pharmacy and Science students and professionals aspiring to make a career in Clinical Research.

Clinnovo Research Labs is a biopharmaceutical services company, provides a range of clinical research, consulting, and technology products and services to the pharmaceutical, biotechnology, and medical device industries worldwide. Clinnovo group of companies was founded in 2005 and is headquartered in Hyderabad, India. Clinnovo Offers Services & Training In Clinical Research Course, Clinical Data Management Training, Sas, SDTM, ADaM, Medical Coding, Imaging, Pharmacovigilance and Drug Regulatory Affairs. Online Clinical Course, Class Room, Pg Diploma, Internships Available.

Clinnovo Offers Services & Training In Clinical Research Course, Clinical Data Management Training, Sas, SDTM, ADaM, Medical Coding, Imaging, Pharmacovigilance and Drug Regulatory Affairs. Online Clinical Course, Class Room, Pg Diploma, Internships Available