DR ANTHONY MELVIN CRASTO,WorldDrugTracker, helping millions, A 90 % paralysed man in action for you, I am suffering from transverse mylitis and bound to a wheel chair,With death on the horizon, This will not stop me, Gods call only..........
DR ANTHONY MELVIN CRASTO Ph.D ( ICT, Mumbai) , INDIA 29Yrs Exp. in the feld of Organic Chemistry,Working for GLENMARK PHARMA at Navi Mumbai, INDIA. Serving chemists around the world. Helping them with websites on Chemistry.Million hits on google, world acclamation from industry, academia, drug authorities for websites, blogs and educational contributio

Monday, 30 May 2016

Janet P. Engle, PharmD, PhD (Hon), FAPhA, FNAP

Janet P. Engle, PharmD, PhD (Hon), FAPhA, FNAP

Pharmacy Practice

833 South Wood Street
Room 164 MC 886
Chicago, IL 60612
PHONE: 312-996-6300
FAX: 312-996-0379

Janet P. Engle, PharmD, PhD (Hon), FAPhA, FNAP

Department Head, Professor, Pharmacy Practice


833 S. Wood Street, 166A (886)
Chicago, Illinois 60612
Fax: (312) 996-0379


  • BS, Pharmacy, Rutgers University, Piscataway, New Jersey
  • PharmD, University of Illinois at Chicago, Chicago, Illinois


Dr. Engle's areas of interest include community and ambulatory care, non-prescription drugs and self-care, pharmacy education and academic administration.


  • President, American Pharmacists Association


Journal Article

  • Nutescu EA, Engle JP, Bathija S, , Chan J, Mucksavage JJ, Ohler KH, Tesoro EP, Thielke JJ, Shapiro NL, Donnelly AJ, Garofalo J, DiDomenico RJ. "Balance of academic responsibilities of clinical track pharmacy faculty in the United States: a survey of select American College of Clinical Pharmacy Practice and Research Network Members.". Pharmacotherapy. 2014;34(12):1239-49. doi:10.1002/phar.1521.
  • Engle JP, Erstad BL, Anderson, Jr DC, Bucklin MH, Chan A, Donaldson AR, Hagemann TM, O'Connell MB, Rodgers PT, Tennant S, Thomas Z. "Minimum qualifications for clinical pharmacy practice faculty.".Pharmacotherapy. 2014;34(5):e38-44.
  • Havrda DE, Engle JP, Anderson KC, Ray SM, Haines SL, Kane-Gill SL, Ballard SL, Crannage AJ, Rochester CD, Parman MG. "Guidelines for resident teaching experiences.". Pharmacotherapy. 2013;33(7):e147-61. doi:10.1002/phar.1250.
  • Engle JP. "Guidelines for Resident Teaching Experiences". . 2013;.
  • Engle JP. "The ACCP Field Guide to Becoming a Standout Pharmacy Residency Candidate.". . 2012;.
  • Chisholm-Burns MA, Spivey CA, Billheimer D, Schlesselman LS, Flowers SK, Hammer D, Engle JP, Nappi JM, Pasko MT, Ross LA, Sorofman B, Rodrigues HA, Vaillancourt AM. "Multi-institutional study of women and underrepresented minority faculty members in academic pharmacy.". American journal of pharmaceutical education. 2012;76(1):7. doi:10.5688/ajpe7617.
  • Schwartz SM, Bansal VP, Hale C, Rossi M, Engle JP. "Compliance, behavior change, and weight loss with orlistat in an over-the-counter setting.". Obesity (Silver Spring, Md.). 2008;16(3):623-9. doi:10.1038/oby.2007.96.
  • Zierler-Brown SL, VanAmburgh JA, Casper KA, Krypel LL, Salcido AL, Padron VA, Pray WS, Wall AL, Sobotka JL, Engle JP. "Status and recommendations for self-care instruction in US colleges and schools of pharmacy, 2006.". American journal of pharmaceutical education. 2006;70(6):139.
  • Dlugosz CK, Chater RW, Engle JP. "Appropriate use of nonprescription analgesics in pediatric patients.".Journal of pediatric health care : official publication of National Association of Pediatric Nurse Associates & Practitioners. 2006;20(5):316-25; quiz 326-8. doi:10.1016/j.pedhc.2006.07.001.
  • Dekhtawala KN, , Engle JP. "Pharmacy education and practice in France.". American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists. 1996;53(13):1600-2.
  • Engle JP, Firman SC. "Perfecting pharmacist presentation skills.". American pharmacy. 1994;NS34(7):60-71; quiz 71-3.
  • Engle JP. "Caring for contact lenses.". American pharmacy. 1994;NS34(3):73-82.
  • Engle JP. "Assessing and counseling contact lens wearers.". American pharmacy. 1993;NS33(11):39-45.
  • Engle JP. "OTCs' role in cost-effective health care.". American pharmacy. 1993;NS33(5):4.
  • Engle JP, Donnelly AJ. "Selecting a nonprescription internal analgesic.". American pharmacy. 1993;NS33(5):28-34.
  • Engle JP. "Topical nasal decongestants.". American pharmacy. 1992;NS32(5):33-7.
  • Engle JP. "Leadership and professionalism in pharmacy.". American journal of hospital pharmacy. 1991;48(7):1559-62.
  • Engle JP, Leoni JM, Donnelly AJ. "Management of alcohol withdrawal: treatment controversies.". American pharmacy. 1988;NS28(11):51-7.
  • Engle JP, Polin KS, Stile IL. "Acute iron intoxication: treatment controversies.". Drug intelligence & clinical pharmacy. 1987;21(2):153-9.


  • Engle JP. (2002). "150 years of pharmacy: our patients, our passion.". Journal of the American Pharmaceutical Association (Washington,D.C. : 1996). Vol. 42. Issue 5 Suppl 1. Page(s) S7-9.
  • DA Solimando, Jr , Engle JP. (1990). "Comment: Pharmacy specialization.". DICP : the annals of pharmacotherapy. Vol. 24. Issue 10. Page(s) 1011-2.
Photo of Janet P. Engle, PharmD, PhD (Hon), FAPhA, FNAP
The UIC Department of Pharmacy Practice is one of the largest and most productive departments in the country.  Our faculty are known across the US and around the world for their expertise. The department continues to grow and operationalize the strategic plan developed in 2011.
In 2014, the department recruited for several faculty positions in both Chicago and Rockford.   Faculty were hired in the specialty areas of critical care, ambulatory care including antithrombosis, medication therapy management, GI/hepatology, specialty pharmacy and ambulatory care administration.  Louise Parent Stevens was promoted to Assistant Director, Introductory Pharmacy Practice Experiences (IPPE).  This year, two of our clinical faculty members, Kristen Goliak and Frank Paloucek, were promoted to Clinical Associate Professor and Clinical Professor, respectively.  All promoted clinical faculty now receive multi-year contracts dependent upon rank.
The residency and fellowship program had another strong year.  In 2014, the UIC Community Pharmacy Residency Program was accredited and recruited its third resident who is based out of the UIC outpatient pharmacies.  The Resident Teaching Certificate Program was offered to all residents at UIC as wells as other residents in the Chicago area.  Supplementing the residents’ noon report was a leadership curriculum conducted by the Department Head and topics related to pharmacy administration and UI Health provided by the Director of Pharmacy.  The Residency Advisory Committee met on a regular basis and oversaw the operations of the residency program. Each year a residency retreat is held to discuss and further improve our program.
The Department Advisory Committee, an elected committee consisting of faculty and administration, met on a monthly basis during most of 2014.  One of the projects completed was the development of a research vision for the department which is included later in this annual report following the department mission statement. The research vision has been helpful as the department began recruiting for several mid-career tenure track faculty positions.
Our faculty continue to engage in cutting edge research.   From Young Jeong’s work on altered drug metabolism in pregnancy which was funded with a grant from the National Institutes for Health for $1.7 million, to Jeremy Johnson’s work with cancer chemoprevention agents funded by the American Cancer Society for just over $720,000 and to Larry Danziger’s work with the Illinois Manufacturing Extension Center for over $2 million just to name a few projects, our faculty are world-renowned and contributing to new knowledge through their research programs.  Competitive research funding continues to increase as our faculty continue to get funded in this competitive environment.  More information on faculty research projects can be found later in this report.
The Department of Pharmacy Practice along with the Department of Pharmacy Systems, Outcomes and Policy established the Center for Pharmacoepidemiology and Pharmacoeconomic Research (CPR) several years ago.  The Center is an interdisciplinary research unit of the College of Pharmacy.  The Department is collaborating with CPR in a pilot program to provide research assistance for the clinical faculty. To date, the pilot has been going well.
As in the past, the Department of Pharmacy Practice faculty continue to be active in international pharmacy.  In 2014, faculty members were invited to present lectures at international meetings in China, Dubai, India, Malta, Japan, Philippines, Saudi Arabia, Thailand, Taiwan and Singapore.  Our faculty also continue to give lectures and recitations to pharmacy students in Hong Kong and Malta. The Department also hosted many international pharmacists from partner schools for short-term visits to learn more about clinical pharmacy.  Andy Donnelly helped coordinate 2 visits for directors of hospital pharmacy from China to learn about clinical pharmacy services and education program development in the US.  Christina Mactal Haaf and Jennifer Pham continued in their positions as the UIC Coordinators for the collaborative degree programs the College has established with University of Hong Kong and University of Malta.  Several of our faculty were awarded adjunct faculty status at University of Malta to recognize their contributions to the program. Nancy Shapiro continued as the program coordinator for our international summer program, “Contemporary Pharmacy Practice and Education” for students and pharmacists from Taiwan and Hong Kong which took place for one month during the summer.  To give our students the opportunity to experience pharmacy practice in another country, we have partnered with Siriraj Hospital and  Mahidol University in Bangkok, Thailand to develop an elective APPE rotation for our P4 students.
As mentoring and faculty development are important initiatives in the Department, the mentoring and faculty development programs continued to grow in 2014.  Over 60 faculty are involved in the mentoring program as a mentor or mentee.  Since the mentoring and faculty development programs’ debut in 2008, 15 clinical faculty have successfully achieved promotion to clinical associate or clinical professor.  In addition, since 2008, 7 tenure track faculty have successfully pursued promotion to associate professor or professor.  The mid-career faculty development program continued in 2014 for the mid-level and senior clinical faculty in order to increase opportunities for scholarship in the department.  One aspect of the program allows promoted or close to promoted faculty the ability to request to be taken off of service for 4-12 weeks to pursue or complete a scholarly activity such as a research project or writing a paper.  Several faculty have taken advantage of this option.  In addition, faculty development programming targeted at mid-career faculty was continued where visiting faculty are invited to campus to meet with faculty and participate in the visiting faculty seminar series.  The goal of the program is to help mid-career faculty reach successful promotion to full professor.
In addition to faculty development seminars and workshops, the department also held a faculty networking event that recognized departmental faculty who had received significant awards.  The awardees who were recognized included:
¨ Issac Cha: Allen Golden Apple, UIC TRP, Co-Teacher of the Year, Class 2015
¨ Arnold Diaz: INSPIRE Award and UIC Award of Merit
¨ Andy Donnelly: ICHP Amy Lodolce Mentor of the Year Award
¨ Linda Grider:  UIC COP Alumnus of the Year
¨ Kristen Goliak:  AACP Academic Leadership Fellow
¨ Jennifer Marcelo: 2014 Pharmacy Today One to One Patient Counseling Recognition Program
¨ Mary Moody:  ICHP Pharmacist of the Year
¨ Jimmy Nguyen: 2014 UIC Student Employee All Star Award
¨ Kirsten Ohler:  Preceptor of the Year, Class of 2014 PGY1s
¨ Mat Thambi:  Preceptor of the Year, Class of 2014
¨ Scott Wirth:  Co-Teacher of the Year, Class of 2015
Not only did the faculty have the opportunity to network with each other but also had the opportunity to celebrate our faculty successes.
In addition to the faculty networking event, the Department also organized a networking mixer during the fall semester for P4 students, residents and faculty.
The Department also continued the networking functions for our faculty, preceptors, donors and alums called the Partners in Practice events.  During these functions we celebrate our partnerships with our preceptors who support our educational program, our generous donors who make many of our activities and scholarships possible and our alums who continually give back to the Department in a number of ways.  For example, over the years, our preceptors have donated approximately $100,000 to the College and for that we are very grateful. Events were held at the American Pharmacists Association (APhA) Annual Meeting in Orlando and during the summer at a White Sox game at US Cellular Field in Chicago.  We had great attendance at both events and plan to continue hosting these functions.
The departmental Educational Policy Committee (EPC) under the leadership of Kristen Goliak continues to meet on a regular basis.  This past year, the Committee spent time focused on the College curriculum revision providing input to the College curriculum committee.  The department EPC also reviewed the then proposed new ACPE accreditation standards and provided formal, written feedback to ACPE outlining the department’s viewpoints and concerns.  The Standards were approved by the ACPE Board in 2015 and several of our concerns were addressed.  The Department EPC committee also developed a recitation leader evaluation form to be used by the students and a policy and procedure for faculty recitation evaluation.  The Committee also reviews all of the concerns that arise as part of the fall and spring course coordinator meetings and addresses the issues as appropriate.
To celebrate American Pharmacists Month in 2014, the Rockford APhA Academy of Student Pharmacists (ASP) placed an ad commemorating the month on a billboard on Alpine and Broadway.  The billboard was displayed for the month of October and was sponsored by ASP, the Dean’s Office and the Department of Pharmacy Practice.   The department was happy to help sponsor the billboard and the ASP students’ activities in Rockford.
Providing the highest level of pharmaceutical care to the patients that seek care from our seven ambulatory pharmacies continues to be an important focus for our department.  Three clinical faculty members who have completed community pharmacy residencies and have expertise in community pharmacy continue to enhance clinical services provided at the Wood Street Pharmacy.    Two of these faculty also provide care to underserved patients at Community Health, a free clinic on the west side of Chicago run completely by volunteers.   A new initiative in our ambulatory pharmacies, UI Team Rx, was developed that enhances patient-centered coordination of care.  More about this unique program can be read later in this report. We have continued various marketing strategies for our pharmacies which include publishing a blog on a variety of topics that is supported by the Drug Information Group, maintaining a social media presence on facebook and twitter and developing new marketing pieces for our pharmacies.
The new Mile Square Pharmacy, one of our several ambulatory pharmacies, moved to the new Mile Square building on the corner of Wood and Roosevelt and had their grand opening celebration in October 2014.  The pharmacy is state of the art and includes a counseling room, a space for P4 students to work and video screens where educational videos can be shown.  It is a great, new space to provide care to our patients.
Our ambulatory pharmacies as well as faculty in the Department continued to be very active in providing flu shots to the university community via our pharmacies as well as through our partnership with the State of Illinois.  For the 9th year, department faculty, residents and P4 students worked together to administer flu vaccine to as many eligible state employees and retirees as possible.  Over 1350 vaccinations were administered during the 2014 flu fall season as part of this program.  To be sure all of our immunizing pharmacists were eligible to participate in the vaccination programs, we offered a CPR refresher course for those whose CPR certification had expired.
Many of our faculty are active in the American College of Clinical Pharmacy (ACCP).  In 2014, several faculty had leadership positions.  These include:
  • Melissa Badowski, Chair HIV PRN and Chair, Emerging Distance Practice and Technology Committee
  • Michelle Martin, Secretary/Treasurer GI/Liver/Nutrition PRN
  • Rebecca Stone, Secretary/Treasurer Women’s Health PRN
  • Nancy Shapiro, Chair, Task Force on Residency Training
  • Jan Engle, Chair, Educational Affairs Committee
ACCP Committee/Task Force members include:  Rob DiDomenico, Alan Lau, Juliana Chan, and Vicki Groo.  Also of note, Melissa Badowski completed the requirements for the ACCP Teaching and Learning Academy and was recognized at the graduation ceremony at the 2014 annual meeting.
It has been a busy and productive year for the department. Below is a summary of some of the activities of the department for 2014:
  • 173 publications
  • 33 books or book chapters
  • 39 editorial boards or editorships
  • 7 media interviews
  • 92 presentations
  • 91 leadership/committee positions
  • 16 college/campus awards
  • 13 state/national awards
  • 1 international award
These activities could not have been accomplished without the hard work of the faculty, staff, residents and fellows.   While not all accomplishments of the department could be featured in this report, these highlights are just a few of the contributions made to the college, university and profession of pharmacy.


Abha Dosh

Abha Dosh.

Abha Dosh

PRINCIPAL at MET Institute of pharmacy







MET Institute of pharmacy
 – Present (16 years 3 months)Bandra Reclamation, Mumbai
3years of Industrial experience, 19 years of teaching and 15 years of administration

Principal's Message
'VIDHYA DHANAM SARVA DHAN PRADHANAM’ is the motto of the MET League of College.  The MET Institute of Pharmacy offers both Diploma & Degree courses in Pharmacy.  The students, fresh out of junior college are trained in the various aspects of pharmaceutical sciences and then they emerge as professionals in the field of pharmacy.  We believe not only in academic excellence but also in the overall development of our students. With high moral values, our students blend professionalism and a sense of social responsibility so as to be recognized as dutiful citizens of the country.
Over the last 15 years some of our students by virtue of being 'university toppers' have made us proud.  Each year the academic excellence is reflected by the number of students who are distinction holders.  At the same time, our students also actively participate in the intercollegiate events like Rx festival and lot of extra-curricular activities throughout the year.
Once the students have graduated in the field of pharmacy manifold options are available to them.  They have pursued higher studies in the field of pharmacy/management (in India or abroad), joined the industry, hospital pharmacy and clinical research.  Wherever they have been, the METizens have left their mark and done us proud.
Dr. Abha Doshi
Principal - MET Institute of Pharmacy

Abha Doshi

Abha Doshi

MET Institute of Pharmacy, India
Title: Current GMP guidelines


Abha Doshi is a Principal of MET Institute of Pharmacy, Mumbai, India. She has 20 years of teaching and administrative experience and 3 year of industrial experience in production in Ranbaxy Laboratories Ltd. She has guided many MPharm students and presented research work in various national and international conferences. She has published many research articles in national and international journals.


Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. These are the system to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process every time a product is made. Many countries have formulated their own requirements for GMP based on WHO GMP guidelines. GMP is referred to as cGMP mostly in United States of America which refers to current good manufacturing practice. The current GMP guidelines are formulated with continuous improvement and addition in the recent past. These guidelines provide minimum requirement that a pharmaceutical or a food product manufacture must meet to assure that the products are of high quality and do not pose any risk to the consumer or public. These requirements concern methods, equipment or testing which are used for the production, processing, packaging and/or storage of drugs. This ensures that medicine products fulfil the necessary quality criteria. Good quality must be built-in during the manufacturing process; it cannot be tested into the product after wards. Current GMP is designed to ensure that mistakes do not occur again. Systems and equipment which are used to prevent contamination mix ups and error, which may have been top of the line 20 years ago, may be less than adequate by today’s standard. There has to be continuous improvement and updating in the systems, procedures and software’s from time to time by the company. It will be dealt in detail in the talk.

Need pain relief?
No more pills and injections
The good news
Good news for all those who hate popping pills or fear needles. Faculty Researchers at MET Institute of Pharmacy, Mumbai have formulated a simple answer to pain relief. "We have formulated a medicated 'Buccal' patch that can be placed inside the mouth. The blood vessels inside the mouth will absorb the medicine directly and the patient will be relieved of pain." Says Dr. Abha Doshi who leads the research team. Dr. Doshi is the Principal of MET Institute of Pharmacy (degree) and is also an award-winning author of the prestigious M L Khorana award, conferred on her in 2003, for her paper on Pharmaceutical and Medicinal Chemistry.
Two options for pain-relief
The 'Buccal' patch has been developed for fast action and sustained relief. There is a possibility of the fast acting 'Buccal' patch to be a simpler alternative for patients averse to needle pricks and tablets.
No side effects
A medical innovation, this patch promises to be a simple answer to side effects like gastric irritation caused by pills. "Non-steroidal anti-inflammatory drugs -NSAIDs taken for pain relief have to pass the stomach and liver before entering the bloodstream. This process is longer and also causes gastric irritation. By using the 'Buccal' patch the drug is directly absorbed into the blood stream to the areas where it is supposed to treat thus bypassing the stomach and liver and eliminating side-effects." Says Bhagyashree Joshi from the MET research team.
Lower dosage required
Says Sheeja Koliyote, "Since the drug directly enters the blood stream, the dosage required to treat the condition is much less. E.g. The 'Buccal' patch with 20 mg drug will give the same effect as an oral tablet containing 50 mg of the drug. Sheeja Koliyote is the third member of the research team.
When will this product hit the market?
MET Institute of Pharmacy have conducted this laboratory research. However, we are not producers of product we are producers of research. When leading pharmaceutical companies come to know about this, they will surely be interested in using this research for new formulation development.
Is the 'Buccal' patch addictive? Does it have side effects?
It is envisaged to be a prescribed drug meant for therapeutic treatment. Further researches and tests are still underway to validate all other possibilities.
How much will it cost?
Can't say. But the cost is estimated to be in the same range as tablets for the same drug.
How much wieghtage does this research carry?
The faculty team consisting of Dr. Abha Doshi - Principal - MET Institute of Pharmacy (degree), Ms. Sheeja Koliyote - Faculty - MET Institute of Pharmacy (degree), Ms. Bhagyashree Joshi - Faculty - MET Institute of Pharmacy (degree) were invited to attend the 5th World Meeting on Pharmaceutics, Biopharmaceutics and Pharmaceutical Technology from March 27 to 30, 2006 at Centre International de Conferences Geneve - CICG, Geneva, Switzerland where they presented their research findings.
MET is dedicated to newer research findings
Several faculty members of MET Institute of Pharmacy have been presenting research papers in national and international conferences. Moreover, few of the research papers have been published in reputed journals. "Research gives the cutting edge. As an Institute committed to research, development and dissemination of relevant knowledge we constantly endeavour to provide path-breaking researches to the corporate and academia" says Trustee , MET League of Colleges.
Over the years, MET Institute of Pharmacy has emerged as a thought-leader in providing path-breaking researches to corporates and academia.
Other Research Papers by MET Faculty
A paper was presented to the Association of Pharmaceutical Teachers of India in Nagpur entitled " A Novel Technique To Measure Rat Paw Edema" authored by Dr. U.B. Hadkar, Dr. Sonali Ghatpande and Mrs. Mrinal. M. Sanaye. It was a simple reliable economical method to measure rat paw edema which requires a pool of Hg. This method can be used as an alternative to current expensive method which involves the use of plethysmometer.
The research paper was published in the December 2006 issue of Pharma bioworld magazine.

Dr. Hema Bajaj

Dr. Hema Bajaj

Affiliate Quality Officer - Heading Quality Assurance and Medical Excellence for Sanofi Pharma. Ops., India
Head of Clinical Quality & Medical Compliance - Affiliate Quality Officer
Sanofi Aventis
  • Senior professional with 11 plus years’ experience in Medical Quality and Marketing Compliance spreading across Promotional Ethics and Compliance, Product Quality, Drug safety, and Quality processes.
  • Currently heading affiliate quality systems for Sanofi India Pharma and lead Clinical Quality and Marketing Compliance for Sanofi, India for 9 years.
  • Have been instrumental in setting up novel electronic Transparency Platforms and implementing Quality/Compliance Systems at Sanofi India, in accordance with Sanofi Global Quality Policies, Quality Directives, Standards, International and local regulatory requirements.
  • Areas of expertise include Quality Management, Project Management, Quality Assurance, Pharmacovigilance, Ethical Compliance, Business Excellence, Learning and Development.
  • Marketing Ethics and Compliance: ensure compliance with industry standards like MCI rules, DoP, IFPMA, OPPI guidelines for ethical promotion, ethical interaction with healthcare professionals, medical institutions, patient organizations and implementation of transparency policy across all Sanofi Franchise (Pharma, Pasteur, Genzyme and Shantha Biothenics).
  • Organizational Quality Management for Pharmacovigilance and other departments: Ensure Quality organization and management of Quality Documents to support Quality and Compliance Program for Pharmacovigilance, Medical Affairs Quality, and other departments.
  • Project management: participate and lead team for business critical projects from start-ups to implementation for affiliate and region.
  • Quality Management: Ensure Quality audits/ checks are conducted and hosted - internal and external customer audits, and inspections including company audits, system audits, process audits, site audits, and certification audits (e.g.; ISO certification, etc.)
  • Training and tracking: ensure training of PV, Quality and Medical on company standards, and external stakeholders (KOLs, investigator teams, ethic committee members, etc.) across hospitals and institutions, on industry standards and regulations.
  • Data analysis and reporting: Perform quality assurance consulting projects, data analysis and reporting for process improvements, product quality, PTCs.
  • Team Management and Development: training and mentoring Pharmacovigilance and Quality, Medical Affairs team members; planning, assign


• Sr. professional with almost 11 yrs of experience in Clinical Research industry in leading & implementing of Affiliate Quality Systems in compliance with Company Standards & Regulatory requirements.
• Heading Clinical Quality & Medical Compliance for Sanofi, India since almost 7 years - Affiliate Quality Officer.
• Key ability to provide Quality leadership across Organization with priority focus on GCP and health regulated activities.
• Key ability to work in matrix organization, collaborating with Business & Sr. Leadership of the Company.
• Expertise in: Quality Management & QA, Compliance, Project Management, Business Excellence, Training - Learning & Development
• Quality Assurance: conduct & host internal/external audits/inspections: system audits, process audits, site audits, vendor audits, & ISO certification audits. Manage Organizations Quality procedures
• Compliance: ensure compliance with industry stds: MCI rules, OPPI guidelines-ethical promotion, ethical interaction with external stakeholders, & implementation of transparency policy
• Project management: lead team for business critical projects from start-ups to implementation for affiliate/region
• Data analysis & Reporting: perform QA consulting projects, data analysis & reporting for process improvements
• People Management: training/mentoring team members, appraising performance & guiding professional development
• Regional role: collaborating with Region/South Asia for development & implementation of special projects
• Progressive experience in building teams & Quality dept. from inception
• Developing and managing company’s medical compliance program, aligning to applicable regulations, with focus on operations of Sales, Marketing, Comm.Ops. & Medical Affairs
• Training of team on company standards and regulations. Structuring & conducting clinical research trainings & workshops for over 100 KOLs & 60 hospitals across India.


Head of Clinical Quality & Medical Compliance - Affiliate Quality Officer

Sanofi India Limited.
 – Present (9 years 5 months)Mumbai, India
- As a Quality lead for the affiliate, responsible for management of an appropriate affiliate quality system in India, with prime focus on quality aspects for Medical and Regulatory Affairs division, supporting Clinical Study Unit.
- Partner with the business to lead and coordinate the implementation business critical affiliate projects for India in compliance both with Sanofi quality standards and local regulatory requirements, concerning activities related to marketing, launch, clinical investigation of products developed and/or marketed in the country.
- Bring Quality insight into the Governance and ways of working in place within the affiliate.

Head of Clinical Quality & Medical Compliance - Sr. Manager Clinical Quality.

Sanofi India Limited.
 – Present (9 years 5 months)Mumbai, India
• Manage department and overall expectations pertaining to setting accurate schedules, costs and resources.
• Partner with Senior Leadership team and Management to identify team needs, quality gaps and implement solutions.
• Be the local point of contact for the corporate Sanofi at affiliate level for initiating and implementing Quality systems across organization.
• Direct and lead the development of tools for risk assessment and audit techniques for use for quality management.
• Implement ongoing quality improvement processes working with interdepartmental teams in matrix organization.
• Develop and manage quality assurance metrics for performance improvement of all teams.
• Set up Systems, Process Mapping, Compliance Monitoring and Training on various company standards and regulations for ethical conduct of trials (GCP)
• Audit Related: provide necessary definition, development and deployment of clinical quality assurance strategy, per the requirement. Liaise with each concerned affiliate medical function to ensure continuous audit readiness by ad hoc connections with the expert groups in charge at Global level.
•Experience in API audits and Data management audit for third party.
- Develop compliance communications and undertake investigations of potential compliance issues in accordance with company policy. Prepare reports of compliance activities and metrics. Counsel and provide leadership with business partners on compliance process issues.
• Set up Quality Systems and ensure compliance to sanofi and industry standards for ethical Healthcare Professional, Healthcare Organization and Patient Association interactions.
• Quality Document Management: Develop and manage entire life-cycle of QD for medical division across divisions’ per identified requirements, global and local regulations.
• Trainings: Internal and industrry trainings.
• Metrics and Reporting.

Medical Quality Officer

 –  (1 year 4 months)Mumbai Area, India
Roles & Responsibilities
• Conducting interdepartmental audits in line with ISO requirements.
• Was instrumental in procuring first ISO 9001 – 2000 certification for Quintiles ECG Services division.
• Support company auditor in conducting and hosting internal study audits and sponsor audits carried out on regular intervals.
• Perform quality assurance consulting projects, data analysis and reporting for process improvements.
• Perform Quality trend analysis presentations to the team and sending out monthly Quality Report to the Medical Director and Director of the organization.
• To act as the final level of quality control to ensure error free data reaches the site/sponsor.
• To collect and interpret error data at all levels and present error data of the unit on a regular basis, and present the quality trend report to the management.

Recruitment and Training Officer

 –  (8 months)Mumbai Area, India
Roles & Responsibilities
• Work with human resource manager and business leaders to craft talent strategy enabling hiring, development and retention of the best quality talent in the competitive environment.
• Screen and interview potential candidates’ esp. w.r.t. medical know-how and assist in the coordination of recruitment, selection and training of staff to meet specific requirements.
• Assist in various projects like Training Need Analysis, benching marking, competence mapping in order to ensure optimum resource utilization.
• Induction/Training of the new joinees and mentoring and managing resource allocation within the team.
• Support the performance management process for the assigned business, addressing performance issues, rewarding superior performance. Work closely with the human resource manager and business to identify top talent & reward them.
• Spearhead the ‘Talent Review’ process across the business and develop & deploy various structured talent management interventions.
• Develop & Deploy Role Based Training modules for the business.

Assistant Doctor

Dr. Kasad’s Homoeop. Clinic
 –  (5 months)
Managing Out Door Patient Department

Assistant Doctor

Homoeopathic Health Center
 –  (2 years 1 month)
Managing the outpatient department. Assisting the Senior doctor in publications.Conducting trainings along with the team of doctors on various aspects of homoeopathy

Dr.D.S. Sharada


Dr.D.S. Sharada 
Assistant Professor,
Department of Chemistry,
Indian Institute of Technology Hyderabad,
Ordnance Factory Estate, Yeddumailaram - 502 205,
Andhra Pradesh, INDIA.
Email: sharada [at] iith.ac.in    Phone: +91 40 2301 7058

Areas of Interest: Synthetic Organic Chemistry - Development of New Synthetic Methodologies, Heterocyclic Chemistry and Medicinal Chemistry.
Ph.D., School of Chemistry, University of Hyderabad, Hyderabad, 2004.
M.Sc., Osmania University, Hyderabad, 1998.
B.Sc., Osmania University, Hyderabad, 1996.
Work Experience:
Assistant Professor, (August, 2011–present)
Department of Chemistry,
Indian Institute of Techology, Hyderabad
Yeddumailaram 502205. INDIA.

Principal Investigator, (2010-2011)
Women Scientists Scheme (DST, WOS-A),
Organic Chemistry Division (Mentor: Dr. P. T. Perumal),
Central Leather Research Institute, Chennai, INDIA.

Research Scientist, (2005-2009)
Pharmaceutical companies- Orchid Research Laboratories Ltd.,
Chennai, INDIA.

Postdoctoral Fellow, (2004-2005).
Chemistry Department,
North Carolina State University,
Raleigh, North Carolina, USA.