regulatory affairs as a career path

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Plamena Entcheva-Dimitrov, PhD, RAC On-line Course

www.PreferredRegulatoryConsulting.com

www.PreferredRegulatoryConsulting.com 2

The Preferred Regulatory Consulting content in this presentation is copyright protected under United States law and applicable international copyright laws.

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Why Regulatory? What do we do? What is the growth potential? What are the necessary skills? What do you need to know and where do you

learn it?


High impact on the company Interactive Stimulating See all – do all Sense of accomplishment


Study, interpret and apply the regulations Advise the company on newly published or on

upcoming changes to existing laws/regulations / standards

Work with R&D on product development – follow regulations from product’s inception

Prepare submissions to regulatory agencies Involved in the clinical trial design and conduct Standard Operating Procedures Continuously train the organization on

regulations/guidances/directives/standards Safety reporting pre- and post-market Involved in product recalls


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Regulatory Product Development

Engineering Clinical

Non-clinical

Process Development Chemistry

Reimbursement

IP Lawyer Quality

Assurance


The sky is the limit!!!


Individual contributor Management track Expand into Clinical Affairs,

Quality Assurance or both

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morning

noon

evening


PhDs MDs/PharmDs Lawyers MBAs Engineers MS Chemists


Analytical Critical thinker “Roll up your sleeves and get the job done”

approach “Can do” attitude Creative Team player/excellent interpersonal skills Integrity Detailed oriented Excellent writing skills Mentor/educator


FDA responsibility, authority, jurisdiction and structure: Inspections Warning letters Recalls Suspension / withdrawal of approvals Seizure Injunctions Civil and criminal penalties

EU Directives, Regulations Health Canada Australian Therapeutic Goods Administration (TGA) Many other emerging markets (e.g. Brazil, China,

India)


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• Food, Drug and Cosmetics Act of 1938 • Medical Device Amendments of 1976 • The Food and Drug Administration

Safety and Innovation Act (FDASIA) of 2012

Laws

Center Specific Guidance Documents

Regulations: Code of Federal Regulations

Title 21

• Good Laboratory Practices • Conduct of Human Research • Labeling Requirements • Recalls • Safety Reporting • Facility Registration • Audits / 483s


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Directives

Standards (ISO, IEC)

Guidances (MEDDEVs)

Consensus statements

Interpretative documents


MEDICAL DEVICES DRUGS / BIOLOGICS

I. Quality Systems Regulations II. 21 CFR 807 and 814 for

submission content and format: 510(k), de novo, PMA, HDE

III. IDE for clinical studies IV. Design Control Concept V. EU Medical Device Directives

VI. ISO Standards VII. Complaint handling and

vigilance reporting

I. GMPs II. 21 CFR 314 for submission

content and format : NDA, BLA

III. IND for clinical studies IV. Quality by Design V. EMA – EU legislations and

regulations VI. ICH Guidelines VII. Vigilance reports


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On-line courses Universities Social networking, e.g. LinkedIn The regulators


Networking, networking, networking Find a mentor

Open-minded Positive attitude Self-educate


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You have completed a 30-minute regulatory affairs on-line training

You can print this page for your records


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regulatory affairs as a career path

Documents

quality systems regulations

clinical affairs

product recalls

clinical trial design

directives standards

eu medical device directives

iso standards

regulatory agencies