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Mr. DAYANAND CHAWARE

C/O Sunil Nayak

Door No.304, Block 4, LIG 3, KGB

Colony, Surya City Phase1, Anekal

Main Road,

Chandapura Bangaluru-560099.

Mob # +91-973*******

E-mail # admmlj@r.postjobfree.com

TOTAL EXPERIENCE (8 Years and More)

Chemistry, manufacturing and controls data (CMC Data).

Animal pharmacology data, Animal toxicology data and human clinical pharmacology data.

Probing of drugs regulatory requirements for clinical studies.

Reviewing of documents required like-CMC data, Clinical, nonclinical, chemical, pharmaceutical and control, stability, COAs, dissolution data and other internal documents for clinical trial approval and dossier submission to Regulatory Authority for Clinical studies approval.

Preparation, review and amendments of required regulatory documents and information for submission to regulatory authorities for Phase I to IV clinical studies.

Review and requirements of clinical studies documents like protocol, ICDs, CRF, IUs, LOA and REMS and Other documents as per regulatory guidelines.

Registration of Clinical Trials with Clinical Trial Registry (CTRI India).

Review of EDC data, AE and SAE data in Oracle/data base.

Notification of Serious Adverse Events (SAEs) and SAEs related query

(follow ups, typo errors, compensation, medical treatment and other annual study reports ASR and other clarifications response to the regulatory authorities.

Review of Informed Consent and Process documentation, Review of CRF entries against Source Documents.

Submission of protocol amendments & Clinical trial report and study related information to the regulatory authorities.

Getting additional site approval.

Query responding raised by regulatory authorities on Clinical trial, SAE related, other regulatory.

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SEC documents like Rationale, Risk v/s benefit, justification and executive summary report and power point presentation on study.

Requirements and handling of online India Regulatory portal SUGAM.

Review and requirements of clinical studies documents like protocol, ICDs, CRF, IUs, LOA and REMS and Other documents as per regulatory guidelines.

Clinical Study report review.

Drug Coding in MedDRA.

Having of Well knowledge of ICG GCP and undergone training under Dr. Anupama Ramkumar CEO & Principal Consultant, Arkus Research.

Regulatory status of study drug.

Checking of regulatory requirements to conduct the studies.

As per regulatory requirements preparation, review required regulatory documents.

Review of Protocol, ICF and Other EC documents according to regulatory guideline.

Review of CMC documents and other document required to get the approval of study.

Interacting Submission of documents to CDSCO, Zone and Subzone CDSCO and CBN

Requesting and review of required documents for Clinical trial Approval.

Registration of Clinical Trials with Clinical Trial Registry, if required.

Reporting of Serious Adverse Events (SAEs) to the regulatory authorities.

Review of Case report forms, protocols, ICDs and other documents.

Interacting with regulatory to get study NOCs, import license and other NOCs.

Review and evaluate technical and scientific data and reports required for submission.

Review and requirements of clinical studies documents as per regulatory

guidelines.

Query Resolving: responding to queries raised by regulatory authorities.

Interacting with regulatory to get study Biologics product import NOCs for testing and clinical trial purpose.

Submission of protocol & related information to the regulatory authorities.

Getting approval for Trial and Import NOCs from CDSCO. Page 3 of 5

JOB RESPONSIBILITIES

Periodic Routine Study-specific monitoring at CROs.

Preparing schedule for Qualification / Requalification of CROs to conduct BA/BE Studies/Audit at CROs.

To review monitoring reports and assess the quality systems of CRO.

Handling of investigation product/IMPs.

Ensure all monitoring & audit observations are satisfactorily addressed and resolved.

To review Clinical Study Case report forms CRFs, Protocol review for various country of Submission like US, EU, WHO, AUS and report review.

Preparation of Clinical overview & Non-clinical overview.

Preparation of SmPC, CMI, PI.

Frequent checking of regulatory guidelines regarding bioequivalence study design.

Monitor the clinical site of CRO for different BA/BE study.

Verification of documents received from FR&D.

Receiving IMPs from Plant/FR&D.

Received document verification along with IMPs and finalization.

Dispatching IMPs to CRO site along with relevant documents.

Coordinate with IPR department regarding Patent expiry, patent exclusivity checking.

Solve queries received from regulatory bodies or client or patient.

Preparation of product summary sheet for US, EU, WHO, AUS submission.

Compilation of prepared documents of Module 2, Module 4 and Module 5 For Regulatory submission

Review of documents as per eCTD standards and publishing in Pharma Ready tool.

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JOB RESPONSIBILITIES

Medication use management, medication- Regimen Review, Medication use evaluation and Prevention of Medication errors.

Compliance with NABH & JCI Standards in Hospital. (MM&U Chapter of JCI, IPSG).

AEs & ADR Detection, management and reporting. (Naranjo Scale).

Drug interaction study & Casualty assessment. (Micromedex Software, the Stockley's Interactions Checker and Drugs.com).

Medication process audit. (Prescription error, indent error, dispensing error, administration error and category).

Antibiotic stewardship in ICU & WARD.

Ward round medication management (storage of medicines, environment, freeze temperature, expiry, physical appearance, high risk drugs, mixing of drugs, labelling, inventory and crash cart act.)

Appropriate drug management. (encounter in the perioperative area are missing beyond-use dates (BUDs) on multidose vials (MDVs); the use of single-dose vials

(SDVs) as MDVs; nursing carts left unlocked while unattended; and improperly labelled medication drawn into a syringe for administration & to ensure that medications drawn into a syringe are labeled according to hospital regulatory standards.).

Mixing injectable drugs.

Provision of drug information (usage, dosage, stability, incompatibility, pharmacological effects and adverse effects).

Contribute on Rational use of drug, safety management, reduction of works of other medical staff, and also the medical economics through pharmaceutical care.

Assist daily with medication dosing, selection, and dispensing; compounded sterile preparations; Surgical Care Improvement Project (SCIP) guideline compliance; cost containment practices; narcotic dispensing and diversion methods; pharmaceutical waste disposal; and regulatory compliance.

Surgical Care Improvement Project (SCIP) & JCI has promoted three Pre-operative antibiotic (Prophylactic Antibiotic) - SCIP-inf-1, SCIP-inf-2, SCIP-inf-3.

International Patient Safety Goals (IPSG): High-Alert Medications, Health Care- Associated Infections.

Formulary System (Evaluate, advice P&T committee on efficacy, ADRs, cost, ongoing needs).

Communication and Education.

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SCHOLASTICS

QUALIFICATION BOARD/UNIVERSITY PERCENTAGE

OBTAINED

YEAR OF

PASSING

Master of

Pharmacy

(Pharmacology)

Rajiv Gandhi University of

Health Sciences, Bangalore,

Karnataka, India.(RGUHS)

71.56% May 2012

Bachelor of Pharmacy

(B. Pharmacy)

RGUHS, Bangalore. 65.58% 2009

Diploma in

Pharmacy (D.

Pharmacy)

Drug Control Department

Bangalore, Karnataka,

India

63% 2004

P.U.C Science Secondary Education

Examination Board,

Bangalore, Karnataka

48% 2002

SSLC Karnataka Secondary

Education Examination

Board, Bangalore,

Karnataka.

60.96% 2000

AREA OF INTEREST

Regulatory Affairs.

Clinical Trial and BA/BE Studies.

Pharmacovigilance.

Software Knowledge &

Credentials

Oracle OCRDC.

ARISg .

MedDRA.

CTRI Credential.

CDSCO SUGAM Online portal.

Central Bureau of Narcotics (CBN) Credential.

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PERSONAL VITAE

Nationality : Indian

Sex : Male

Passport No : L6142091

Languages Known : English, Hindi, Kannada, Marathi and Telgu Marital Status : Married

PERAMNENT ADDRESS :

S/O. Bandeppa Chaware

AT- Basavakayan Taluk Hulsoor

DIST-Bidar, State- Karnataka, India, PIN-585416

DECLARATION:

I vouch the authenticity of the above-mentioned information. Given an opportunity, I promise you to put my sincere efforts to rise to your expectations and become an asset to your esteemed organization. DAYANAND CHAWARE

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