Innovating in the life sciences and health-care sector? You can’t escape the regulators! Before you make a costly mistake, learn from the experts who have been through the process before.
Whether you’re working on a therapeutic, an in vitro diagnostic or a medical device, come find out how to identify and mitigate challenges along the path to regulatory approval.
Innovative Drug Pipeline Solutions: Medicinal Chemistry, Process Chemistry, cGMP API Manufacturing. 105+ global clients. 120,000 sq.ft. facilities located in Research Triangle Park, NC USA. FDA inspected and DEA registered.
Innovative Drug Pipeline Solutions: Medicinal Chemistry, Process Chemistry, cGMP API Manufacturing. 105+ global clients. 120,000 sq.ft. facilities located in Research Triangle Park, NC USA. FDA inspected and DEA registered.
Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
Silence Therapeutics Unaudited Preliminary Results 2011 - March 2012.
Featuring 2011 Highlights, an overview of Silence's performance and products, and an analysis of the commercial landscape of the field of RNAi.
How To Manage and Mitigate Risk in Medical Device New Product DevelopmentGreenlight Guru
A company’s ability to understand and manage risk can mean the difference between financial success and disaster.
(You can view the full webinar here: http://www.greenlight.guru/risk-in-medical-device-new-product-development-webinar)
In this webinar you'll learn:
- How to understand the true nature and impact of project and product risk
- How to effectively measure risk quantitatively
- How to use risk management as a tool to accelerate NPD
- What you need to know about the upcoming risk-based changes to ISO 13485 to ensure compliance
Moving from drug discovery to drug development requires a particular skillset usually not yet honed by start-ups. This phase of the development process is highly regulated and, critically, inexperienced start-ups often underestimate the duration and cost of delivering the dosage form into the clinic while meeting regulations.
This presentation will address the following:
* aspects of the Chemistry, Manufacturing and Control (CMC) portion of the drug development process
* bioavailability and the Biopharmaceutics Classification System (BCS)
* objectives of formulation
* cost-effective strategies to reach key milestones
Beyond the Solar Module: Optimizing system performance and maximizing returns...MaRS Discovery District
Optimizing system performance and maximizing returns requires a holistic approach that combines the study and application of components, materials and processes.
Learn more about these three areas:
* the state of the market for solar PV balance of systems (BOS)
* best practices for system monitoring, operations and maintenance
* challenges and potential solutions for Ontario’s connection and grid constraints, as seen by utilities and developers
Many technology ventures are focused on securing funds from venture capitalists (VCs). This lecture focuses on understanding the motivation of private venture capital firms and how it affects the structure of their term sheets and legal agreements. We explore common pitfalls in dealing with VCs, as well as success stories regarding VC investment.
Social networking platforms have changed the way we build and manage relationships, but how have they impacted health care?
Find out how social networks can fill gaps in our current system of health-care delivery and support improved quality of care.
http://www.marsdd.com/events/details/social-networks-and-health-care/
This session highlights what entrepreneurs should consider at the start of their venture, what they need to do as the company grows and what needs be done as the business matures and the owner contemplates an exit or retirement.
Rise of the Business User: Enterprise IT and the effect of consumerization - ...MaRS Discovery District
From Skype to the iPad to Google Docs, business users are introducing consumer-driven technology into the workplace and enterprise IT is struggling to stay ahead of the curve. Will the onslaught of consumerization drive groundswell innovation, or will it lead to a security meltdown?
http://www.marsdd.com/events/details/rise-of-the-business-user-enterprise-it-and-the-effect-of-consumerization/
Scynexis Fully Integrated Drug Discovery & Development 2011 Overviewbrycechaney
SCYNEXIS provides fully-integrated contract research solutions including medicinal chemistry, discovery biology, ADMET-PK, bioanalysis and analytical chemistry, process chemistry and cGMP manufacturing. We have delivered 11 Preclinical Candidates (PCCs) to our clients since 2005. We are FDA and DEA inspected.
Ask yourself - Do you want compounds... Or do you want DRUGS?
Silence Therapeutics Unaudited Preliminary Results 2011 - March 2012.
Featuring 2011 Highlights, an overview of Silence's performance and products, and an analysis of the commercial landscape of the field of RNAi.
How To Manage and Mitigate Risk in Medical Device New Product DevelopmentGreenlight Guru
A company’s ability to understand and manage risk can mean the difference between financial success and disaster.
(You can view the full webinar here: http://www.greenlight.guru/risk-in-medical-device-new-product-development-webinar)
In this webinar you'll learn:
- How to understand the true nature and impact of project and product risk
- How to effectively measure risk quantitatively
- How to use risk management as a tool to accelerate NPD
- What you need to know about the upcoming risk-based changes to ISO 13485 to ensure compliance
Moving from drug discovery to drug development requires a particular skillset usually not yet honed by start-ups. This phase of the development process is highly regulated and, critically, inexperienced start-ups often underestimate the duration and cost of delivering the dosage form into the clinic while meeting regulations.
This presentation will address the following:
* aspects of the Chemistry, Manufacturing and Control (CMC) portion of the drug development process
* bioavailability and the Biopharmaceutics Classification System (BCS)
* objectives of formulation
* cost-effective strategies to reach key milestones
Beyond the Solar Module: Optimizing system performance and maximizing returns...MaRS Discovery District
Optimizing system performance and maximizing returns requires a holistic approach that combines the study and application of components, materials and processes.
Learn more about these three areas:
* the state of the market for solar PV balance of systems (BOS)
* best practices for system monitoring, operations and maintenance
* challenges and potential solutions for Ontario’s connection and grid constraints, as seen by utilities and developers
Many technology ventures are focused on securing funds from venture capitalists (VCs). This lecture focuses on understanding the motivation of private venture capital firms and how it affects the structure of their term sheets and legal agreements. We explore common pitfalls in dealing with VCs, as well as success stories regarding VC investment.
Social networking platforms have changed the way we build and manage relationships, but how have they impacted health care?
Find out how social networks can fill gaps in our current system of health-care delivery and support improved quality of care.
http://www.marsdd.com/events/details/social-networks-and-health-care/
This session highlights what entrepreneurs should consider at the start of their venture, what they need to do as the company grows and what needs be done as the business matures and the owner contemplates an exit or retirement.
Rise of the Business User: Enterprise IT and the effect of consumerization - ...MaRS Discovery District
From Skype to the iPad to Google Docs, business users are introducing consumer-driven technology into the workplace and enterprise IT is struggling to stay ahead of the curve. Will the onslaught of consumerization drive groundswell innovation, or will it lead to a security meltdown?
http://www.marsdd.com/events/details/rise-of-the-business-user-enterprise-it-and-the-effect-of-consumerization/
Getting Bought by Google: Or another technology heavyweight - MaRS Best Pract...MaRS Discovery District
What do technology majors or other desirable purchasers really seek? What do they value that would not be obvious unless you had been through such a deal? How can past success be replicated? Does IP really matter? And most importantly, how does one build a strong valuation?
Using practical case studies, this presentation focuses on aspects of acquisitions that may be new to many entrepreneurs.
http://www.marsdd.com/events/details/bought-google-technology-heavyweight/
This lecture covers all the essentials of building and delivering an effective pitch to help you find financing for your entrepreneurial venture or sell your product to customers. Learn the elements of a good pitch deck and identify the key elements of good communication that successful start-ups use.
Lecture video: http://www.marsdd.com/entrepreneurs-toolkit/sessions/the-pitch
Where are you in your drug development journey? Find out how to expedite your drug development program. View our drug development journey map. Download the document to zoom in and view details.
Innovating in the life sciences and health-care sector? You can’t escape the regulators! Before you make a costly mistake, learn from the experts who have been through the process before.
Whether you’re working on a therapeutic, an in vitro diagnostic or a medical device, come find out how to identify and mitigate challenges along the path to regulatory approval.
David Glass Presentation at 2010 Algae Biomass SummitDavid Glass
Slides from a presentation given by David Glass, "Impact of Biotechnology Regulations on Use of Genetically Modified Algae in Biofuel Production", at the 2010 Algae Biomass Summit, Phoenix, AZ, September 28, 2010.
Biosimilar is the term coined for protein drugs that are similar, but not identical to, an existing product. Copies of biopharmaceuticals (proteins) that can be made after the patent on the original product has expired Example: Epoetin, G-CSF, insulin, somatropin
CDSCO Biologicals - Rules, Regulations, Guidelines and Standards for Regulato...Mohamed Fazil M
M. Pharmacy - Pharmaceutical Regulatory Affairs (MRA)
1st Semester - Regulations and Legislation for Biologics (MRA 104T)
Unit 2 - Rules, Regulations, Guidelines and Standards for Regulatory Filing of Biologicals
CDSCO Biologicals
Pharmaceutical Product & Process Design & QualityAjaz Hussain
A reflection on progress made, and challenges to be addressed, in realizing the desired state articulated by the the FDA Initiative on Pharmaceutical Quality for the 21st Century.
Regulatory Compliance in Pharmaceutical DevelopmentGL.docxsodhi3
Regulatory Compliance in Pharmaceutical Development:
GLP & GMP
Jeffrey G. Sarver, Ph.D.
MBC 3100
March 8, 2016
email questions to:
[email protected]
*
Food and Drug Administration (FDA)Agency of U.S. Department of Health and Human Services (HHS)Protect public health and provide essential public servicesOther HHS agencies include: CDC, NIH, Medicare/MedicaidFDA responsible for assuring safety and efficacy of: Human Drugs - Center for Drug Evaluation and Research (CDER)Veterinary Drugs - Center for Veterinary Medicine (CVM)Biological Agents - Center for Biologic Evaluation and Research (CBER)Medical Devices - Center for Devices and Radiological Health (CDRH)Food/Supplements/Cosmetics - Center for Food Safety and Applied Nutrition (CFSAN)
Manufacture
Market Drug
NDA
FDA Review
Clinical
Trials
I, II, III
IND
FDA Review
Preclinical
Testing
Drug
Discovery
Drug Development/Approval ProcessIND – Investigational New Drug application (3-6 yr, $5M-$10M)FDA Approval → Proceed into Clinical Trials (~30% from preclinical tests)Clinical Hold → Collect More data or End DevelopmentNDA – New Drug Application (9-12 yr, $500M-$1B)FDA Approval → Drug Enters Market (~8% from preclinical tests)Not Approved → More Data or Adjust Application or End Development
Basic
Research
+
Target
Discovery
Preclinical Testing RequirementsMechanism of Action (in vitro) and Efficacy (in vivo)General Toxicology: Single and Repeated Dose (in vivo)Genotoxicity/Mutagenicity (in vitro/in vivo)Carcinogenicity (in vivo)Reproductive Toxicology/Teratology (in vivo)ADME (in vitro)/Pharmacokinetics (in vivo)Additional Safety TestingCore: Cardiovascular (hERG), Respiratory, CNSOther tests as needed based on structure, mechanism, general tox
Additional Information for INDChemistry, Manufacturing, and Controls (CMC)Structure, physical propertiesSynthetic method and scale-upPurity, identification of impuritiesDosage form/route, formulation, preparation, packagingClinical Study ProtocolsPrevious Human Experience (if available)
FDA Guidance Documents
Information on suggested: testing methods, analyzing and summarizing data
Can be found at: http://www.fda.gov/RegulatoryInformation/Guidances/Searching can be difficult/tedious, use appropriate filters:Product → Drugs (or Biologics)FDA Organization → CDER (or CBER)Document Type → Guidance DocumentsExample Guidance Documents available on Blackboard:Genotoxicity TestingCardiotoxicity (hERG) TestingChemistry, Manufacturing, and Controls (CMC) for Phase I DrugMaximum Safe Starting Dose for Clinical Testing
International Council on Harmonization (ICH)Harmonize procedures for evaluating/reporting safety, efficacy, CMC in multiple regions/countriesRegulators and industry representatives from participating regions collaborate to generate internationally acceptable guidelinesImprove efficiency of drug testing/reporting requirements for approval in multiple countriesOriginally Europe, Japan, U.S.Other countries adopting IC ...
Part of the MaRS Best Practices Series - Pre-Clinical development workshop
http://www.marsdd.com/bestpractices/
Speaker: James Ault, VP Regulatory Affairs, Ricerca BioSciences
Don Tapscott's New Solutions for a Connected Planet - MaRS Global LeadershipMaRS Discovery District
In this new age of networked intelligence, collaborative communities are enhancing and even bypassing crumbling institutions. We are innovating the way our financial institutions and governments operate; how we educate our children; how the healthcare, newspaper, and energy industries serve their customers; how we care for our neighbourhoods; and even how we solve global problems.
From his latest book, (co-author Anthony D. Williams) Macrowikinomics: New Solutions for a Connected Planet, Don Tapscott presents groundbreaking innovations from every corner of the globe: how businesses, organizations and individuals alike are using mass collaboration to revolutionize not only the way we work, but how we live, learn, create and care for each other.
SR&ED: What you need to know about the changing landscape - MaRS Best PracticesMaRS Discovery District
The Scientific Research and Experimental Development (SR&ED) tax incentive program provides support in the form of tax credits to groups or individuals conducting scientific research or experimental development in Canada.
Some significant changes are on the way as a result of the last federal budget. See how these new rules could affect you!
Geoff Mulgan, CEO of Nesta UK's presentation on The Paradoxes of Ageing and How to Overcome Them at the Business of Aging Summit 2012 held on April 30, 2012 at the MaRS Discovery District.
Barbara Jaworski, of Workplace Institute's presentation on Older Workforce Strategy presented at Business of Aging Summit, April 30, 2012 at MaRS Discovery District.
Improving profitability for small businessBen Wann
In this comprehensive presentation, we will explore strategies and practical tips for enhancing profitability in small businesses. Tailored to meet the unique challenges faced by small enterprises, this session covers various aspects that directly impact the bottom line. Attendees will learn how to optimize operational efficiency, manage expenses, and increase revenue through innovative marketing and customer engagement techniques.
Personal Brand Statement:
As an Army veteran dedicated to lifelong learning, I bring a disciplined, strategic mindset to my pursuits. I am constantly expanding my knowledge to innovate and lead effectively. My journey is driven by a commitment to excellence, and to make a meaningful impact in the world.
In the Adani-Hindenburg case, what is SEBI investigating.pptxAdani case
Adani SEBI investigation revealed that the latter had sought information from five foreign jurisdictions concerning the holdings of the firm’s foreign portfolio investors (FPIs) in relation to the alleged violations of the MPS Regulations. Nevertheless, the economic interest of the twelve FPIs based in tax haven jurisdictions still needs to be determined. The Adani Group firms classed these FPIs as public shareholders. According to Hindenburg, FPIs were used to get around regulatory standards.
LA HUG - Video Testimonials with Chynna Morgan - June 2024Lital Barkan
Have you ever heard that user-generated content or video testimonials can take your brand to the next level? We will explore how you can effectively use video testimonials to leverage and boost your sales, content strategy, and increase your CRM data.🤯
We will dig deeper into:
1. How to capture video testimonials that convert from your audience 🎥
2. How to leverage your testimonials to boost your sales 💲
3. How you can capture more CRM data to understand your audience better through video testimonials. 📊
"𝑩𝑬𝑮𝑼𝑵 𝑾𝑰𝑻𝑯 𝑻𝑱 𝑰𝑺 𝑯𝑨𝑳𝑭 𝑫𝑶𝑵𝑬"
𝐓𝐉 𝐂𝐨𝐦𝐬 (𝐓𝐉 𝐂𝐨𝐦𝐦𝐮𝐧𝐢𝐜𝐚𝐭𝐢𝐨𝐧𝐬) is a professional event agency that includes experts in the event-organizing market in Vietnam, Korea, and ASEAN countries. We provide unlimited types of events from Music concerts, Fan meetings, and Culture festivals to Corporate events, Internal company events, Golf tournaments, MICE events, and Exhibitions.
𝐓𝐉 𝐂𝐨𝐦𝐬 provides unlimited package services including such as Event organizing, Event planning, Event production, Manpower, PR marketing, Design 2D/3D, VIP protocols, Interpreter agency, etc.
Sports events - Golf competitions/billiards competitions/company sports events: dynamic and challenging
⭐ 𝐅𝐞𝐚𝐭𝐮𝐫𝐞𝐝 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬:
➢ 2024 BAEKHYUN [Lonsdaleite] IN HO CHI MINH
➢ SUPER JUNIOR-L.S.S. THE SHOW : Th3ee Guys in HO CHI MINH
➢FreenBecky 1st Fan Meeting in Vietnam
➢CHILDREN ART EXHIBITION 2024: BEYOND BARRIERS
➢ WOW K-Music Festival 2023
➢ Winner [CROSS] Tour in HCM
➢ Super Show 9 in HCM with Super Junior
➢ HCMC - Gyeongsangbuk-do Culture and Tourism Festival
➢ Korean Vietnam Partnership - Fair with LG
➢ Korean President visits Samsung Electronics R&D Center
➢ Vietnam Food Expo with Lotte Wellfood
"𝐄𝐯𝐞𝐫𝐲 𝐞𝐯𝐞𝐧𝐭 𝐢𝐬 𝐚 𝐬𝐭𝐨𝐫𝐲, 𝐚 𝐬𝐩𝐞𝐜𝐢𝐚𝐥 𝐣𝐨𝐮𝐫𝐧𝐞𝐲. 𝐖𝐞 𝐚𝐥𝐰𝐚𝐲𝐬 𝐛𝐞𝐥𝐢𝐞𝐯𝐞 𝐭𝐡𝐚𝐭 𝐬𝐡𝐨𝐫𝐭𝐥𝐲 𝐲𝐨𝐮 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐚 𝐩𝐚𝐫𝐭 𝐨𝐟 𝐨𝐮𝐫 𝐬𝐭𝐨𝐫𝐢𝐞𝐬."
An introduction to the cryptocurrency investment platform Binance Savings.Any kyc Account
Learn how to use Binance Savings to expand your bitcoin holdings. Discover how to maximize your earnings on one of the most reliable cryptocurrency exchange platforms, as well as how to earn interest on your cryptocurrency holdings and the various savings choices available.
VAT Registration Outlined In UAE: Benefits and Requirementsuae taxgpt
Vat Registration is a legal obligation for businesses meeting the threshold requirement, helping companies avoid fines and ramifications. Contact now!
https://viralsocialtrends.com/vat-registration-outlined-in-uae/
Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
Looking for professional printing services in Jaipur? Navpack n Print offers high-quality and affordable stationery printing for all your business needs. Stand out with custom stationery designs and fast turnaround times. Contact us today for a quote!
Business Valuation Principles for EntrepreneursBen Wann
This insightful presentation is designed to equip entrepreneurs with the essential knowledge and tools needed to accurately value their businesses. Understanding business valuation is crucial for making informed decisions, whether you're seeking investment, planning to sell, or simply want to gauge your company's worth.
Event Report - SAP Sapphire 2024 Orlando - lots of innovation and old challengesHolger Mueller
Holger Mueller of Constellation Research shares his key takeaways from SAP's Sapphire confernece, held in Orlando, June 3rd till 5th 2024, in the Orange Convention Center.
Building Your Employer Brand with Social MediaLuanWise
Presented at The Global HR Summit, 6th June 2024
In this keynote, Luan Wise will provide invaluable insights to elevate your employer brand on social media platforms including LinkedIn, Facebook, Instagram, X (formerly Twitter) and TikTok. You'll learn how compelling content can authentically showcase your company culture, values, and employee experiences to support your talent acquisition and retention objectives. Additionally, you'll understand the power of employee advocacy to amplify reach and engagement – helping to position your organization as an employer of choice in today's competitive talent landscape.
2. Avoiding
Pi*alls
in
the
Regulatory
Path
Best
Prac7ce
Sessions
MaRS
Discovery
District
30
SEP
2011
Sonia
Sanhueza,
PhD
Prac7ce
Lead
&
Advisor,
Life
Science
&
Healthcare
2
3. Avoiding
Pi*alls
in
the
Regulatory
Path
1. Pharma
/
Biotech
/
Medical
Device
Product
Life
Cycle
2.
Regulatory
and
Quality
Requirements
3.
Common
Pi*alls
and
Consequences
4.
Avoiding
Pi*alls
5.
US
FDA
483
/
Warning
LeRer
6.
Summary
3
4. Product
Life
Cycle
Drugs
/
biotech
/ Claims
biologics
IFU
concept
POC
Pre-‐clin
clinical
approval
$$$$
Quality
/
Regulatory
requirements
Japan’s
European
Pharmaceu7cal
Health
US
FDA
Medicine
and
Medical
Canada
Devices
Agency
Agency
(PMDA)
The
Interna'onal
Conference
on
Harmonisa'on
(ICH)
of
Technical
Requirements
for
Registra7on
of
Pharmaceu7cals
for
Human
Use
5. Product
Life
Cycle
Medical
devices
Claims
IFU
valida7o
concept
prototype
Tes7ng
approval
$$$$
n
Quality
/
Regulatory
requirements
Japan’s
Competent
Pharmaceu7cal
Health
US
FDA
Authority
in
and
Medical
Canada
the
MS
Devices
Agency
(PMDA)
5
6. Drugs
/
Biotech
/
Biologics
GO
/
NO-‐
GO
concept
POC
Pre-‐clin
clinical
approval
$$$$
R&D
10. Drugs
/
Biotech
/
Biologics
Quality
and
Regulatory
Requirements
• General
provisions
of
current
Good
Manufacturing
• Responsibility
of
management.
• Conduc=ng
audits,
taking
correc=ve
ac=on
and
documen=ng
results.
• Crea=ng
design
controls:
input,
output,
valida=on,
transfer,
changes
and
documenta=on.
• Purchasing
and
the
evalua=on
of
suppliers.
• Iden=fica=on
and
traceability
of
products.
• Dealing
with
produc=on
and
process
changes.
• Inspec=on,
measuring
and
tes=ng
equipment.
• Acceptance
ac=vi=es.
• What
to
do
with
non-‐conforming
products.
• Correc=ve
and
Preven=ve
Ac=ons
(CAPA).
• Labeling,
storage,
distribu=on
and
installa=on.
• Records
and
servicing
of
products.
10
11. Drugs
/
Biotech
/
Biologics
Trademark
Regulatory
Requirement
Legal
The
US
Patent
and
Trademark
Office
(USPTO)
is
not
the
only
checkpoint
for
pharmaceu=cal
trademarks.
The
trademark
clearance
process
for
pharma
companies
consists
of
both
a
legal
and
regulatory
process
11
12. Drugs
/
Biotech
/
Biologics
Trademark
Regulatory
Requirement
In
most
cases
the
legal
process
consist
of:
• branding
concept
conceived
by
pharmaceu=cal
branding
specialists
• pool
of
poten=al
brand-‐name
candidates
submiUed
for
considera=on
by
the
marke=ng
or
trademark
development
department
• candidates
are
typically
priori=zed
• forwarded
to
the
company’s
trademark
legal
department
or
law
firm
for
ini=al
screening
(e.g.
Trademark
db
plaXorms)
in
key
jurisdic=ons
to
weed
out
poten=ally
problema=c
candidates
• Candidates
proceed
to
a
full
trademark
legal
clearance
search
(trademark
aUorney)
• providing
a
legal
opinion
as
to
a
trademark’s
poten=al
availability
for
use
and
registra=on
in
connec=on
with
a
par=cular
product
(or
service
in
the
case
of
service
marks)
12
13. Drugs
/
Biotech
/
Biologics
Trademark
Regulatory
Requirement
Specialized
trademark
research
report
-‐
assists
a
trademark
aUorney
in
formula=ng
a
well-‐supported
opinion
on
availability
of
a
pharmaceu=cal
trademark.
It
should
mirror
FDA
review
process
• Should
have
a
name
safety
component
• Include
a
selec=on
of
sources
that
are
reviewed
by
the
FDA
o Orange
Book
(FDA-‐approved
drugs)
o U.S.
Adopted
Names,
USAN,
(generic-‐drug
names)
o include
informaEon
derived
using
known
FDA
methods,
such
as
the
FDA’s
Phone=c
and
Orthographic
Computer
Analysis
algorithm.
13
14. Health
Canada
• 4.
DEFINITIONS
• Brand
name
(or
proprietary
drug
name):
C.01.001.(1)
of
the
Food
and
Drug
RegulaEons
• Chemical
name:
The
chemical
name
of
a
drug
provides
an
unambiguous
picture
of
a
molecule
so
that
a
trained
chemist
can
use
it
to
draw
its
structure
if
required
• Common
name:
C.01.001.(1)
of
the
Food
and
Drug
RegulaEons
states
that
a
"common
name"
means,
with
reference
to
a
drug,
the
name
in
English
or
French
by
which
the
drug
is
(a)
commonly
known
and
(b)
designated
in
scienEfic
or
technical
journals,
other
than
the
publicaEons
referred
to
in
Schedule
B
to
the
Act.
• Generic
name:
The
generic
or
non-‐proprietary
name
describes
the
drug
substance.
• Health
product:
Health
products
include
pharmaceu=cals,
biologicals,
vaccines,
medical
devices,
natural
health
products,
radiopharmaceu=cals
and
veterinary
drug
products.
• Interna7onal
Nonproprietary
Name
(INN):
INNs
iden=fy
a
drug
substance
by
a
unique,
universally
applicable
and
accepted
generic
name.
It
is
noted
that
chemicals
that
do
not
have
a
defined
chemical
composi=on
or
structure
or
that
cannot
adequately
be
described
cannot
be
assigned
INNs
(i.e.,
mixtures
of
substances).
• Look-‐alike
Sound-‐alike
(LA/SA)
Health
Product
Names:
Health
products
that
have
a
similar
wriUen
name
or
similar
phone=cs
to
those
of
another
health
product.
• Product
line
extension:
A
product
line
extension
results
when
a
drug
is
named
by
using
the
brand
name
of
another
drug
with
the
addi=on
of
a
modifying
prefix
or
suffix
that
is
intended
to
dis=nguish
the
new
product
from
the
original
• Proper
name:
C.01.001.(1)
of
the
Food
and
Drug
RegulaEons
states
• Trade-‐mark:
Sec=on
2
of
the
Trade-‐marks
Act
states
that
a
trade-‐mark
is
(a)
a
mark
that
is
used
by
a
person
for
the
purpose
of
disEnguishing
or
so
as
to
disEnguish
wares
or
services
manufactured,
sold,
leased,
hired
or
performed
by
him
from
those
manufactured,
sold
leased,
hired
or
performed
by
others,
(b)
a
cerEficaEon
mark,
c)
a
disEnguishing
guise,
or
(d)
a
proposed
trade
mark.
• Trade-‐name:
Sec=on
2
of
the
Trade-‐marks
Act
states
that
a
trade
name
is
the
name
under
which
any
business
is
carried
on,
whether
or
not
it
is
the
name
of
a
corporaEon,
a
partnership
or
individual.
• United
States
Adopted
Name
(USAN):
USANs
iden=fies
nonproprietary
names
for
drugs
by
establishing
simple,
logical
nomenclature
based
on
pharmacological
and/or
chemical
rela=onship.
14
16. Drugs
/
Biotech
/
Biologics
Common
Pi*alls
• SOPs
-‐
dra`ed
documents,
no
signatures
of
responsible
person,
originals
not
in
place
only
photocopies,
not
enough
detail
for
operators
to
follow
procedures
• Personnel
o lack
of
appropriate
educa=on
o Lack
of
appropriate
training
o Training
not
documented
• Facili7es
o Lack
of
environmental
monitoring
program
or
unreliable
o
Cleaning
procedures
not
validated
o Airflow
velocity
inside
cri=cal
areas
not
well
defined
16
17. Drugs
/
Biotech
/
Biologics
Common
Pi*alls
Tes7ng
procedures
• Acceptance
criteria
not
established
• Specifica=ons
not
in
place
• Inappropriate
reference
standard
• Tests
not
validated
• Results
not
documented
Raw
materials
• Sourcing
material
with
undefined
impuri=es
• Supplier
not
qualified
17
18. Drugs
/
Biotech
/
Biologics
Common
Pi*alls
Clinical
• Conduct
of
clinical
trial
–
lack
of
appropriate
personnel
supervision
• Enrolment
of
subjects
that
did
not
meet
eligibility
criteria
• Failure
to
no=fy
IRB
on
protocol
changes
• Protocol
not
signed
by
inves=gator
• Failed
to
obtain
informed
consent
Customer
Complains
• Parameters
against
which
to
assess
adequacy
of
ac=ons
not
established
• SOP
not
in
place
18
19. Product
Life
Cycle
Medical
devices
Claims
IFU
valida7o
concept
prototype
Tes7ng
approval
$$$$
n
Quality
/
Regulatory
requirements
Japan’s
Competent
Pharmaceu7cal
Health
US
FDA
Authority
in
and
Medical
Canada
the
MS
Devices
Agency
(PMDA)
19
20. MEDICAL
DEVICES
GO
/
NO-‐
GO
concept
prototype
Tes7ng
valida7on
approval
$$$$
• Legal
–
IP
/
Trademark
• Raw
materials
• Suppliers
qualifica7on
R&D
• SOPs
• Tes7ng
>
valida7on
• Processes
• Procedures
• Personnel
• Facility
• Documenta7on
• Design
process
21. MEDICAL
DEVICES
GO
/
NO-‐
GO
concept
prototype
Tes7ng
valida7on
approval
$$$$
QS
R&D
ISO
13485
22. MEDICAL
DEVICES
QS
outputs
ISO
13485
Design
Design
Design
planning
verifica7on
transfer
inputs
Reviews
Change
control
23. MEDICAL
DEVICES
GO
/
NO-‐GO
concept
prototype
Tes7ng
valida7on
approval
$$$$
• Protocols
• Reports
• Document
control
• Process
valida7on
• Environmental
monitoring
• Sta7s7cal
analysis
• CMOs
• CROs
–
clin
• Audits
23
24. MEDICAL
DEVICES
-‐
Quality
Requirements
• Gap
analysis
audit
-‐
Audit
in
which
the
current
level
of
compliance
with
the
appropriate
quality
regula=ons
including
FDA
GMP,
ISO
13485,
Japan
PAL,
Brazilian
GMP
and/or
CMDR
is
determined
for
the
company.
The
gap
analysis
is
typically
conducted
before
a
system
is
implemented
to
iden=fy
areas
of
deficiency.
• Pre-‐assessment
audit
–
It
is
highly
recommend
that
a
pre-‐
assessment
audit
be
conducted
several
weeks
prior
to
a
cer=fica=on
audit.
24
25. MEDICAL
DEVICES
-‐
Quality
Requirements
• Full
or
par7al
internal
audit
-‐
ISO
and
FDA
QSR
(GMP)
require
that
manufacturers
conduct
regular
internal
audits
of
their
quality
management
systems.
Par=al
audits
can
be
conducted
in
which
the
auditor
focuses
on
specific
areas
of
the
quality
system
where
you
suspect
non-‐compliance
occurs
or
have
occurred,
or
focus
on
areas
where
audits
cannot
be
conducted
by
your
in-‐house
internal
auditor
due
to
possible
conflicts
of
interest.
• Subcontractor
or
supplier
audit
-‐
Cri=cal
suppliers
must
be
"controlled."
This
is
not
only
a
good
business
prac=ce,
but
o`en
also
a
regulatory
requirement.
For
example,
if
your
device
is
manufactured
by
a
subcontractor,
it
is
your
responsibility
to
ensure
their
manufacturing
processes
meet
the
appropriate
standards
and
regula=ons.
25
26. MEDICAL
DEVICES
-‐
Quality
Requirements
• ISO
13485:2003,
FDA
Good
Manufacturing
Prac=ces
(GMP),
CE
Marking
and
Canadian
Medical
Device
Regula=ons
(CMDR).
• Management
responsibili=es
to
customers,
to
quality
policy,
and
to
employees.
• Resource
management:
personnel,
materials,
infrastructure
and
facili=es.
• Product
realiza=on
from
the
planning
stages
through
design
development
through
interac=on
with
customers.
• Ways
to
measure,
evaluate,
and
improve
performance
within
the
organiza=on.
• Requirements
for
incident
repor=ng,
technical
files,
and
risk
analysis.
26
27. MEDICAL
DEVICES
–
Common
pi*alls
• Procedures
for
implemen=ng
CAPA
and
document
CAPA
ac=vi=es
are
inadequate
or
non-‐existent
• Results
are
not
documented
or
not
verified
• Procedures
not
in
place
for
the
valida=on
of
the
device
design,
design
requirements
and
document
control
• Acceptance
criteria
for
tes=ng
not
in
place
• Lack
of
maintenance
of
quality
requirements
in
regards
to
suppliers,
contractors,
consultants
27
28. MEDICAL
DEVICES
–
Common
pi*alls
• Device
history
records
(DHR)
for
each
batch,
lot,
unit
are
not
maintained
• Procedures
used
by
operators
to
manufacture
product
are
not
maintained
in
Device
master
records
(DMR)
• Lack
of
compliance
with
established
quality
system
requirements
• Companies
implement
changes
before
performing
iden=fica=on,
documenta=on,
valida=on,
verifica=on,
review,
and
approval
of
design
• Acceptance
of
specifica=ons
not
established
28
29. MEDICAL
DEVICES
–
Common
pi*alls
• Risk
process
and
analysis
not
in
place
• Design
History
File
(DHF)
–
user
needs
and
intended
uses
not
defined
• Design
valida=on
procedures
for
system
integra=on
tes=ng
for
the
device
so`ware
not
established
and
documenta=on
not
in
place
• Personnel
–
training
records
not
in
place
29
30. ROL
OF
SOCIAL
MEDIA
in
REGULATED
COMPANIES
• Regulated
companies
-‐
opportunity
to
engage
with
healthcare
consumers
and
healthcare
professionals
who
are
increasingly
using
the
internet
to
find
health
informa=on
• To
avoid
regulatory
piXalls
it
is
important
to
have
expert
counsel
to:
o address
product
risk
informa=on
o consumer-‐generated
discussion
of
off-‐label
uses
o online
communica=ons
o interac=on
between
consumers
and
healthcare
providers
about
health
topics
that
have
an
impact
on
pa=ent
health
• The
team
tasked
with
overseeing
the
design
and
execu=on
of
a
social
media
campaign
should
be
mul=disciplinary:
marke=ng,
corporate,
regulatory,
medical
affairs,
legal
&
other
relevant
internal
par=es
30
31. ROL
OF
SOCIAL
MEDIA
in
REGULATED
COMPANIES
Guidelines
US
FDA
–
no
official
guideline,
release
informa=on
expected
soon
EU
–
only
internet
communica=on
in
general
It
is
important
to
know
the
boundaries
of
what
will
and
will
not
be
permiUed
31
32. Common
pi*alls
–
Consequences
/
Impact
TIME
IS
MONEY
=
REVENUES
LACK
OF
CREDIBILITY
=
INVESTORS
LOST
MARKET
=
COMPETITIVE
POSITION
32
33. Common
pi*alls
-‐
Consequences
US
FDA
will:
• Request
prompt
ac=on
with
consequences
for
lack
of
ac=on:
o Seizure
o Injunc=ons
o Civil
money
penal=es
• Address
leUer
within
15
business
days
• Withhold
approval
of
any
new
applica=on
or
supplements
lis=ng
the
firm
as
a
drug
manufacturer
• Refusal
by
FDA
of
product
manufactured
at
foreign
facility
to
entry
into
the
USA
• Be
aware:
Not
intended
to
be
an
all-‐inclusive
list
of
viola=ons
33
35.
US
FDA
Form
483
and
/
or
Warning
LeRer
• FDA
Form
483
is
referred
to
as
"No=ce
of
Inspec=onal
Observa=ons."
• The
483
is
issued
by
the
FDA
field
inves=gator
a`er
an
on-‐site
inspec=on
• It
lists
deficiencies
in
your
quality
system.
• The
observa=ons
are
based
on
the
inspector's
interpreta=on
of
the
regula=ons
as
they
relate
to
your
opera=onal
GMP
quality
system.
• The
field
inspector
will
submit
the
finalized
483
to
his/her
superiors;
based
on
the
severity
of
the
findings,
an
FDA
Warning
LeUer
may
be
issued
to
your
firm.
35
36. US
FDA
Form
483
and
/
or
Warning
LeRer
(cont’d)
• You
must
respond
to
the
483
promptly
within
a
=meframe
specified
by
the
FDA.
• Analyze
the
findings
of
the
FDA
Form
483
and/or
Warning
LeUer
• Chart
a
course
of
ac=on
for
your
company
• Propose
"Correc=ve
Ac=ons“
(CA)
to
be
made
to
your
quality
system.
• Provide
a
detailed
response
for
each
item
addressed
in
the
483.
The
quality
and
promptness
of
your
response
to
this
leUer
are
extremely
important
• Suggest
an
appropriate
=meline
to
sa=sfy
the
FDA
• Assist
in
implemen=ng
correc=ve
ac=ons
in
response
to
FDA
Form
483.
• Be
available
to
answer
all
ques=ons
from
you
or
the
FDA
during
your
efforts
to
correct
the
noted
deficiencies
36
51. Summary
• Start
with
the
end
in
mind
-‐
what
is
your
claim?
• Don’t
cut
corners
• Get
exper=se
to
help
you
prepare
the
Regulatory
Requirements
&
Quality
System
– audit
your
quality
system
on
a
regular
basis
to
ensure
compliance
with
the
appropriate
regula=ons
and
standards
in
compliance
with
the
FDA
Quality
System
Regula=on,
European
Device
Direc=ves,
Japan's
PAL,
Brazilian
GMP
and
Canadian
Medical
Device
Regula=ons
(CMDR).
– Failure
to
do
so
can
result
in
poor
product
quality,
loss
of
cer=fica=on
or
lack
of
process
improvement.
• Key
elements
to
have
in
place:
processes,
procedures,
documenta=on,
controls,
training
• Plan
for
tomorrow
51