Expert Details
Regulatory Affairs and Pricing and Reimbursement-European and Emerging Market
ID: 726001
Netherlands
She has consulted with clients on EU REACH regulations.
She has assisted clients with regards to approval of cosmetics to be marketed in EU and Asia-Pacific.
She has develop strategies for product positioning and how to maximize this positioning, review and analyze manufacturing processes for compliance to regulatory requirements in multiple jurisdictions, ensure product specifications meet appropriate standards, and help assess product marketability from a scientific and regulatory standpoint.
She has advised clients on rapidly evolving regulatory policies and monitors international trends to ensure refined solutions are delivered to the clients which includes both prescription and drugs, biologics, devices and many more.
Food or food ingredients that have defined physiological effects do not easily fall into the legal categories of food or drug and often inhabit a grey area between the two. These products in general terms cover health promotion, “optimal nutrition” the concept of enhanced performance – both physically and mentally – and reduction of disease risk factors. Some countries define dietary supplements as foods, while in others they are defined as drugs.
She has provide expert opinion and advice in the areas of technology evaluation / due diligence in nutraceuticals and food supplement product approval.
Some countries define dietary supplements as foods, while in others they are defined as drugs.
She has provided expert opinion and advice in the areas of technology evaluation / due diligence in nutraceuticals and food supplement product approval.
She has adviced on CE marking, quality assurance as well as post-marketing aspects such as medical device vigilance.
In order to license/register a new chemical/biological entity (NCE/NBE), /generic a pharmaceutical company develops a dossier that describes the pharmaceutical quality, safety (in animals and
humans) and efficacy of the product for a specified indication. She has assisted clients by way of:
• Evaluation and assessment of the pharmaceutical quality data, including:
- assessing that the manufacturer(s) of all components, including that of the active
pharmaceutical ingredient and the finished product, are certified
-Mapping the registration process and describing a normative framework
-arranging inspection of manufacturer(s)
-Submission and Approval of dossier
-Liaison with FDA project manager
A generic drug contains the same active ingredients as the original formulation.She has adviced many International clients w.r.t. requirements for dossier as well as routemap for generic drug approval procedure i.e., ANDA procedure-Abbreviated New Drug Application procedure.
She has adviced many International clients w.r.t. requirements for GLP Certification.
GMP is a requirement for manufacturers of foods and medications (including pharmaceuticals, biotechnology products, and active pharmaceutical ingredients) to assure that medications are of the required quality.
She has adviced many International clients w.r.t. requirements for GMP Certification as well as routemap for Inspection Procedure.She has also assisted and prepared documents for Regulatory Authority Inspection.
She has offered timely, insightful, and forward-looking analysis of the pricing and reimbursement (P&R) environment on a global scale.her advice offered a variety of tools and products to enhance P&R intelligence, including same-day analysis, country reports, international pricing databases, and a reference pricing matrix.
This Directive aims to supplement the Community legal framework governing the conditions for the placing on the market of medical devices, by extending legislation to include in-vitro diagnostic medical devices.
She has adviced clients on the implementation of the directive and its consequences.
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Education
| Year | Degree | Subject | Institution |
|---|---|---|---|
| Year: 1998 | Degree: MS | Subject: BIOTECHNOLOGY | Institution: GGU, INDIA |
| Year: 1996 | Degree: BS | Subject: BOTANY, ZOOLOGY, CHEMISTRY | Institution: PANJAB UNIVERSITY, INDIA |
| Year: 2001 | Degree: DIPLOMA | Subject: BUSINESS MANAGEMENT | Institution: TVU, LONDON |
Work History
| Years | Employer | Title | Department |
|---|---|---|---|
| Years: 2008 to Present | Employer: Undisclosed | Title: MANAGING DIRECTOR | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 2007 to 2008 | Employer: OCTOPLUS TECHNOLOGIES N.V. | Title: REGULATORY LEADER | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 2006 to 2007 | Employer: CENTOCOR B.V. (JNJ) | Title: MANAGER-INTERNATIONAL REGULATORY AFFAIRS | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 2005 to 2005 | Employer: FREELANCER | Title: REGULATORY CONSULTANT | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 2004 to 2005 | Employer: ELAN PHARMA LTD. | Title: MANAGER-REGULATORY AFFAIRS | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 2001 to 2004 | Employer: CHILTERN INTERNATIONAL | Title: ASSOCIATE-REGULATORY AFFAIRS | Department: |
Responsibilities:Available upon request. |
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| Years | Employer | Title | Department |
| Years: 1998 to 2001 | Employer: CLINTRIALS INTERNATIONAL | Title: REGULATORY EXECUTIVE | Department: |
Responsibilities:Available upon request. |
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Career Accomplishments
| Associations / Societies |
|---|
| RAPS, TOPRA, IPA |
| Awards / Recognition |
|---|
| •Awarded Johnson& Johnson’s “Encore” (Platinum) Award in recognition of efforts for ALAMEWA processes. •Selected by EFPIA (European Federation of Pharmaceutical Industries Association) as a Member of International regulatory Affairs. •Scientific Representative for the developing countries duly funded by UNESCO. |
| Publications and Patents Summary |
|---|
| Articles published in Pharma Pulse (journal dedicated to pharma industry in Asia): 1.European regulatory environment for medicinal products 2.Registering Biosimilars in EU 3.REACH-New regulations for chemical registration in EU 4.Registration of herbal food supplements in EU 5.Quality assurance—A must for pharmaceutical companies |
Additional Experience
| Expert Witness Experience |
|---|
| Provides strategic input for regulatory matters; Serves Biopharma, Food Manufacturing, Diagnostics, Medical Device and Herbal Companies in order to assist the development and/or product registration within EU; Assist companies in establishing in-house quality systems; setting up Pharmacovigilance function in-house; Assisting clients in developing and executing pricing and reimbursement strategies for new products as well as refining strategies for in-line products |
| Training / Seminars |
|---|
| Prominent speaker at various events in the past and will be present at others in the coming years: 1.CPhI India, 2009 (India) 2.BioLOGIC India, 2009(India) 3.Drug safety for follow-on Biologics, 2009 (USA) 4.World Vaccine Congress, 2009(Singapore) 5.Asian Antibody Congress 2008 (Singapore) 6.Biologic India 2008 (Bangalore) 7.Indian Pharmaceutical Congress 2008 (India) 8.India Pharmaceutical Congress 2007 (India) a).Guest Lecturer for Univ. of Pune, India -2008 (Module covering regulatory affairs in Masters and Diploma courses). b).Provided training to various groups on European and International Regulatory Affairs and Drug Safety (2005-2007). |
| Vendor Selection |
|---|
| Assisted in the management of CROs, external providers or consultants; tracked project timelines and budget. |
Fields of Expertise
abbreviated new drug application, active pharmaceutical ingredient, Current Good Manufacturing Practice, coating material, cosmetic product, drug development, drug regulation, European food label review, food regulation, foreign medical device regulation, Food and Drug Administration drug registration, generic drug, Good Laboratory Practice, Good Manufacturing Practice, United Kingdom medical device reimbursement, In Vitro Diagnostics Directive 98/79/EC, investigational drug, investigational drug procedures, medical device clinical research, medical device premarket approval, medical device process validation, new drug application, over-the-counter drug regulation, package, package-food product interaction, pharmaceutical color additive, pharmaceutical manufacturing, pre-approval inspection, prescription drug, product life cycle, shelf life, pharmacovigilance