2. Regulatory Affairs:
R l t Aff i
A Multi-Task Approach
Orna Oz, PhD
BioMedical Strategy (2004) Ltd
Regulatory & Clinical Affairs Group
Health Care אנליזה וניתוח חברות
January 2010
3. Regulation
Key Role in
Due Diligence
and
d
Market proposition
Stepwise Increase in Company Valuation
Health Care אנליזה וניתוח חברות
January 2010
4. BioMedical Strategy
(2004) Ltd
Clinical & Regulatory Affairs Group
Founded by:
Gal Ehrlich Ami Eyal & Orna Oz
Ehrlich,
The Team:
Scientists experts in
Clinical & Regulatory Affairs
Health Care אנליזה וניתוח חברות
January 2010
5. 01/6/9
• אולטרה שייפ קיבלה חיזוק: ה'טיימס' שלח כתב עד ליוקנעם, המניה
מזנקת %05 .
בכתבה מגדיר הכתב את החברה כ"עמק הסיליקון של היופי הטכנולוגי ."המנכ"ל אסף
איל ל" :-Bizportalהחדשות הגדולות של החברה הגיעו אתמול, כאשר ה -FDAהודיע על
אישור הליך המזורז
01/01/81
• אולטרה שייפ זינקה ב-%82; עד תחילת נובמבר צפויה להגיע
תשובת ה- FDAלמוצר ההרזייה
ל
01/01/13
• אולטרה שייפ צללה: ה -FDAלא העניק אישור למכשיר ההרזייה של
החברה
אכזבה למשקיעי אולטרה שייפ לאחר המתנה של שלושה חודשים, אתמול הודיע מנהל
המזון והתרופות בארה"ב כי הוא דורש הבהרות ונתונים נוספים בטרם אישור מכשיר
ההרזייה, הקונטור 1
אנליזה וניתוח חברות Health Care
0102 January
6. How does it start?
Technology
T h l Medical
M di l need
d
Scientifically Clinical use of
based core
rationales technology
&
Use of Benefits of clinical
use and expected
p
valid t l
lid tools
clinical outcome
Health Care אנליזה וניתוח חברות
January 2010
7. Medical Product
Project Assessment
• Medical need
• Technological solution
• Market Analysis
• Patentability
• Feasible markets and competitors
• Survey on scientific evidence
S e o cie tific e ide ce
• Regulatory and Reimbursement
• Funding
F di
Health Care אנליזה וניתוח חברות
January 2010
8. Medical Device
Definition
D fi i i
• an instrument apparatus … implant in
instrument, apparatus, implant,
vitro reagent, or other similar or related
article,
article including a component part or
part,
accessory
• Used for the diagnosis treatment or prevention of
diagnosis,
disease or condition
and that
• Affects the structure or function of the body
• Does not achieve its function through chemical
action
• Is not metabolized to achieve effect
Health Care אנליזה וניתוח חברות
January 2010
9. Medical Device
Examples
E l
Health Care אנליזה וניתוח חברות
January 2010
11. US Market
Food D
F d & Drug Ad i i t ti
Administration
Health Care אנליזה וניתוח חברות
January 2010
12. FDA is part of the Public Health
Service (PHS) within the Department of
Health and Human Services (HHS).
FDA is headed by a commissioner
appointed by the President with Senate
consent.
consent
Health Care אנליזה וניתוח חברות
January 2010
13. Food & Drug Administration
Health Care אנליזה וניתוח חברות
January 2010
14. FDA/CDRH FOCUS
(Center for Devices and Radiological Health)
Ensuring that medical devices are
“reasonably” safe and effective
reasonably
Health Care אנליזה וניתוח חברות
January 2010
15. Types of FDA Regulated
Products
P d t
• Medical Devices (including IVD) &
Radiation Emitting Products - Center for Devices &
Radiological Health CDRH
• Drugs- Center for Drugs Evaluation & Research
• Biologics- Center for Biologics Evaluation & Research
• Combination Products- Office of Combination Products
• Food and Cosmetics- Center for Food Safety & Applied Nutrition
• Animal feed and Drugs- Center for Veterinary Medicine
Health Care אנליזה וניתוח חברות
January 2010
16. Premarket Life Cycle
y
US market as an example
Quality Assurance
Health Care אנליזה וניתוח חברות
January 2010
17. Project Milestones
• Claim – Intended Use & Indications
• Project Initiation –Requirements Proof of Concept
• Regulatory Strategy
• Product Specification and Risk Analysis
p y
• R&D Plan (development and V&V)
• Ongoing Development
g g p •Quality System
• Design Freeze •Manufacturing
• Pre clinical Verification &Validation
• Premarket Clinical Investigation
• Submission for market clearance/approval
• Post-market activities (clinical study/ies)
Health Care אנליזה וניתוח חברות
January 2010
18. Regulatory Strategy
• Regulatory Classification and existing similar
marketed devices
• P
Pre-clinical Testing
li i l T i
• Clinical Strategy (pre and post market)
• Discussion and recommendations
•Re-assess intended use and/or indications for use
•Re-assess technological (engineering) approach and R&D plan
•Re-assess business plan – designated product, timelines and
budget
Alternative approaches
Health Care אנליזה וניתוח חברות
January 2010
19. Claim / Intended Use
Intended Use:
What is being done
Sometimes where it is being done
Sometimes why it is being done
Indications:
Diseases
Patients
P ti t
Subsets
Health Care אנליזה וניתוח חברות
January 2010
20. Claim
Intended Use & Indications For Use
Design Specifications Test Plan to Verify and
Regulatory & Clinical Validate Claim
V lid t Cl i
strategies (including target
markets))
1. Bench T ti
1 B h Testing
2. Animal Testing
3. Clinical Data
Health Care אנליזה וניתוח חברות
January 2010
21. Regulatory Implications of Claim
SPECIFICITY LEVEL
1. Identification of function Tool Claim
2. Identification of tissue type
an organ system or
(higher clinical
Identification of a specific evidence))
organ
3. Identification of a particular
disease or target population
4. Identification of an effect on
clinical outcome
Clinical Claim
Health Care אנליזה וניתוח חברות
January 2010
22. Regulatory Implications of Claim
SPECIFICITY LEVEL
Tool vs. Clinical – Cardiac Pacing Devices
Tool:
The Frontier Biventricular Cardiac Pacing System is
indicated for maintaining synchrony of the left and
right ventricles in patients who…….
Clinical:
Cli i l
The InSync model 8040 pulse generator is indicated for
the reduction of the symptoms of moderate to severe
heart failure (NYHA Functional III or IV) in those
patients who…….
Health Care אנליזה וניתוח חברות
January 2010
23. Claim / Intended Use
GENERAL VS. SPECIFIC INTENDED USE
The claim(s) for a device can be general or specific.
When deciding the claims for the device it is
g
important to consider not only the marketing goals
but also the regulatory process.
Examples of General vs. Specific Use:
Skin resurfacing vs. Wrinkle removal
vs
Evaluation of soft tissue vs. Aid in differentiation of
benign from malignant breast lesions
g g
Cut/coagulate soft tissue vs. Photorefractive
keratectomy (PRK) for myopia
Health Care אנליזה וניתוח חברות
January 2010
24. Claim / Intended Use
GENERAL VS. SPECIFIC INTENDED USE
Health Care אנליזה וניתוח חברות
January 2010
25. Classification – Risk Based
User/Pt g
Mitigation
Environment RISK Generic
type
Circumstances Claim
Health Care אנליזה וניתוח חברות
January 2010
26. Classification
Class I (Low Risk) ~45%
Examination gloves, Sunglasses, Instruments for
general use (scalpels), Diagnostic Stethoscope
trol
Level of Cont
Class II (Med. Risk) ~47%
Vital signs monitors, Ventilators, Infusion pumps,
o
Incubators, MRI, US
L
Class III (High Risk) ~8
Coronary Stents, Heart Valves, Pacemakers, Implantable Lenses,
new and untested technologies, life-supporting or sustaining….
Health Care אנליזה וניתוח חברות
January 2010
27. Regulatory Pathway
g y y
The class to which the device is assigned determines (among
other things) the type of the required regulatory pathway
and premarketing application:
Exempt
E Class I
Cl
510(k)
( ) Class I or II (Non exempt)
( p)
Class III preamendments device (on the
market prior to 1976, or substantially
equivalent to such a device) and PMA's have
i l h d i ) d PMA' h
not been called for
PMA Class III
Cl
Health Care אנליזה וניתוח חברות
January 2010
28. CDRH’s Risk Based Paradigm
g
Class I
Class II
Class III
Health Care אנליזה וניתוח חברות
January 2010
29. Regulatory Pathway
g y y
De Novo 510(k) (after re-evaluation of an automatic
( )(
class III designation) – NSE & Lower Risk device or
that contemplates “Similar Technologies” and risk
profile.
HDE “medical device intended to benefit patients in
medical
the treatment or diagnosis of a disease or condition
that affects or is manifested in fewer than 4,000
,
individuals in the United States per year.” Similar to
a premarket approval (PMA) application, but exempt
from the effectiveness requirements
f h ff i i
Health Care אנליזה וניתוח חברות
January 2010
30. Regulatory Implications of Claim
DIAGNOSIS VS. MONITORING
BLADDER CANCER KIT
THE UROVYSION BLADDER CANCER KIT (UROVYSION
KIT) IS DESIGNED TO DETECT ANEUPLOIDY FOR
CHROMOSOMES 3, 7, 17 AND LOSS OF THE 9P21 LOCUS
VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN
URINE SPECIMENS FROM PERSONS WITH HEMATURIA
PMA SUSPECTED OF HAVING BLADDER CANCER RESULTS
SUSPECTED OF HAVING BLADDER CANCER.
FROM THE UROVYSION KIT ARE INTENDED FOR USE, IN
CONJUNCTION WITH AND NOT IN LIEU OF CURRENT
STANDARD DIAGNOSTIC PROCEDURES, AS AN AID FOR
UroVysion Kit AS AN AID FOR INITIAL DIAGNOSIS
INITIAL DIAGNOSIS OF BLADDER CARCINOMA IN
PATIENTS WITH HEMATURIA AND SUBSEQUENT
MONITORING FOR TUMOR RECURRENCE IN PATIENTS
PREVIOUSLY DIAGNOSED WITH BLADDER CANCER.
510(K) THE UROVYSION BLADDER CANCER RECURRENCE
KIT (UROVYSION KIT) IS DESIGNED TO DETECT
ANEUPLOIDY FOR CHROMOSOMES 3, 7, 17, AND LOSS
OF THE 9P2L LOCUS VIA FLUORESCENCE IN SITU
HYBRIDIZATION (FISH) IN URINE SPECIMENS FROM
SUBJECTS WITH TRANSITIONAL CELL CARCINOMA
OF THE BLADDER. RESULTS FROM THE UROVYSION
KIT ARE INTENDED FOR USE AS A NONINVASIVE
METHOD FOR MONITORING FOR TUMOR
RECURRENCE IN CONJUNCTION WITH CYSTOSCOPY
IN PATIENTS PREVIOUSLY DIAGNOSED WITH
BLADDER CANCER.
Health Care אנליזה וניתוח חברות
January 2010
31. Regulatory Implications of Claim
DIAGNOSIS VS. MONITORING
THE UROVYSION BLADDER CANCER KIT (UROVYSION
KIT) IS DESIGNED TO DETECT ANEUPLOIDY FOR
CHROMOSOMES 3, 7, 17 AND LOSS OF THE 9P21 LOCUS
VIA FLUORESCENCE IN SITU HYBRIDIZATION (FISH) IN
PMA URINE SPECIMENS FROM PERSONS WITH HEMATURIA
SUSPECTED OF HAVING BLADDER CANCER. RESULTS
FROM THE UROVYSION KIT ARE INTENDED FOR USE, IN
CONJUNCTION WITH AND NOT IN LIEU OF CURRENT
STANDARD DIAGNOSTIC PROCEDURES, AS AN AID FOR
UroVysion Kit INITIAL DIAGNOSIS OF BLADDER CARCINOMA IN
PATIENTS WITH HEMATURIA AND SUBSEQUENT
MONITORING FOR TUMOR RECURRENCE IN PATIENTS
PREVIOUSLY DIAGNOSED WITH BLADDER CANCER.
510(K)
( ) THE UROVYSIONBLADDER CANCER RECURRENCE
BLADDER CANCER
KIT (UROVYSION KIT) IS DESIGNED TO DETECT
ANEUPLOIDY FOR CHROMOSOMES 3, 7, 17, AND LOSS
OF THE 9P2L LOCUS VIA FLUORESCENCE IN SITU
HYBRIDIZATION (FISH) IN URINE SPECIMENS FROM
SUBJECTS WITH TRANSITIONAL CELL CARCINOMA
SUBJECTS WITH TRANSITIONAL CELL CARCINOMA
OF THE BLADDER.
OF THE BLADDER. RESULTS FROM THE UROVYSION
KIT ARE INTENDED FOR USE AS A NONINVASIVE
MONITORING FOR TUMOR RECURRENCE
METHOD FOR MONITORING FOR TUMOR
RECURRENCE IN CONJUNCTION WITH CYSTOSCOPY
IN PATIENTS PREVIOUSLY DIAGNOSED WITH
BLADDER CANCER.
Health Care אנליזה וניתוח חברות
January 2010
32. 510(k)
Determination of SE
Demonstration that a new device is substantially y
equivalent to a legally marketed device (i.e., marketed
before May 28, 1976 or marketed after that date and
was f found substantially equivalent through the
d b i ll i l h h h
510(k) process).
Health Care אנליזה וניתוח חברות
January 2010
33. 510(k)
SE Determination
A device is substantially equivalent if, in comparison
to a legally marketed device it:
has the same intended use; AND
has the same technological characteristics as the legally
marketed device,
OR
has different technological characteristics, and
submitted information does not raise new questions of
q
safety and effectiveness, and it demonstrates that the
device is as safe and as effective as the legally marketed
d i
device.
Health Care אנליזה וניתוח חברות
January 2010
34. 510(k)
SE D t
Determination
i ti
Ref: 2010 RAPS Annual Conference, Christy Foreman, Acting Director, Office of Device Evaluation, FDA
Health Care אנליזה וניתוח חברות
January 2010
35. 510(k)
SE D
Determination
i i
Ref: 2010 RAPS Annual Conference, Christy Foreman, Acting Director, Office of Device Evaluation, FDA
Health Care אנליזה וניתוח חברות
January 2010
36. 510(k)
SE D t
Determination
i ti
Ref: 2010 RAPS Annual Conference, Christy Foreman, Acting Director, Office of Device Evaluation, FDA
Health Care אנליזה וניתוח חברות
January 2010
37. 510(k)
SE D t
Determination
i ti
Ref: 2010 RAPS Annual Conference, Christy Foreman, Acting Director, Office of Device Evaluation, FDA
Health Care אנליזה וניתוח חברות
January 2010
38. PMA (Premarket Approval)
Class III devices which require an approved PMA
application to be marketed include:
High Risk devices which by regulation
require a PMA
New devices for which substantial
equivalency cannot be determined
Could undergo a down classification (de Novo
510(k)) – risk based decision
Health Care אנליזה וניתוח חברות
January 2010
39. Marketing Submissions
While 510(k) devices must only demonstrate
that there are as safe and as effective as a
similar device already marketed
PMA devices must demonstrate, on their
own merit, safety and effectiveness
through valid scientific evidence.
Health Care אנליזה וניתוח חברות
January 2010
40. De Novo 510(k)
( )
If FDA determines the device is not substantially
equivalent (NSE), the applicant may:
resubmit another 510(k) with new data,
file a petition to reclassify the device (i.e., request
review under section 207 of the FDAMA) OR
FDAMA),
submit a PMA application.
Health Care אנליזה וניתוח חברות
January 2010
41. SR vs. NSR Devices
• For the purpose of clinical investigation
Significant Risk (SR) – …presents a potential for
serious risk to the health safety, or welfare of a subject…
safety subject
Is for a use of substantial importance in diagnosing, curing,
mitigating, or treating disease……
Non
N SR (NSR) – d not pose a significant risk t the
do t i ifi t i k to th
human subjects.
• SR devices undergo FDA approval (IDE) prior to
initiating clinical investigations in the US
• Relevant to 510(k) and PMA classified devices
Health Care אנליזה וניתוח חברות
January 2010
42. Marketing Submissions
g
DEVICE USER FEE FOR FY 2011
Type of Application Standard Small
Fee Business*
B i *
PMA $236,298
$236 298 $59,075
$59 075
180-Day Supplement $35,445 $8,861
Real Time Supplement $16,541 $4,135
510(k)’s
510(k)’ $4,348 $2,174
*S
*Small Business: (≤$100 million i annual sales)
ll B i illi in l l )
Health Care אנליזה וניתוח חברות
January 2010
43. Device Approval in Europe
CE M ki
Marking
Health Care אנליזה וניתוח חברות
January 2010
44. Device Approval in Europe
Relevant Authorities
R l A h i i
• Member State of the European Union is any one of the 27
sovereign states that have acceded to the European Union
(EU)
• Competent Authority has the authority to act on behalf of
the government of the Member State to ensure that the
requirements of the Medical Device Directives are transposed
into National Law and are applied
• The Notified Body (NB) is a private, commercial testing
laboratory or certification organization approved by the
y g pp y
Competent Authority in the Member State in which they
have their head-office to carry out some or all of the
Conformity Assessment procedures in the medical device
directives.
Health Care אנליזה וניתוח חברות
January 2010
45. Device Approval in Europe
EC Di
Directives
i
• Medical Devices are regulated by the EC
Directives:
– the Active Implantable Medical Device (AIMD) Directive -
90/385/EEC
– the Medical Device Directive (MDD) 93/42/EEC
– the In Vitro Diagnostic Device Directive (IVD) - 98/79/EC.
h I Vi Di i D i Di i / /EC
– AIMD and MDD are now governed b the Amended Directive
2007/47/EC
• Medical devices may be classified (risk based) as
Class I, Class IIa, IIb and III
• MEDDEV guidance documents
Health Care אנליזה וניתוח חברות
January 2010
46. Device Approval in Europe
• Within the scope of which Directive?
• Classification (The classification rules are based
on different criteria such as the duration of contact
with the patient, the degree of invasiveness and the
part of the body affected by the use of the device).
• Conformity Assessment Route (design and
manufacturing inspections, manufacturing ONLY,
etc.)
t )
• Technical File (Contains all the relevant
information to demonstrate that the product meets
the Essential Requirements of the Directive)
Health Care אנליזה וניתוח חברות
January 2010
47. Device Approval in Europe
Declaration of C f
D l i f Conformity
i
We hereby declare that the distributed CE marked products,
specified in the annexed product list, are covered by the "CE
Marking of Conformity Certificate", reference
g y
number:.....CE.., issued on (date) and delivered by [NAME
OF NB], and conform to the required technical
documentation, in accordance with Annex ___of the "EC-
Directive
Directive", the Council Directive 93/42/EEC of 14 June 1993
amended in September 2007, concerning medical devices.
In addition we ensure and declare that the distributed CE
addition,
marked products, as mentioned and falling within Class XX,
meet the provisions of the EC-Directive which apply to them.
…………………………
.
Health Care אנליזה וניתוח חברות
January 2010
48. Meeting the Regulatory
Authorities
A th iti
Health Care אנליזה וניתוח חברות
January 2010
49. Meetings with FDA
• P IDE:
Pre IDE
– Regulatory strategy: regulatory classification,
test plan (
p (bench test methodologies animal
g
studies), clinical strategy
– Prior to expanding clinical trials from feasibility
to pivotal phase
• Pre-PMA
• Day 100 PMA meetings
• Post-deficiency letter for 510(k) or PMA
• Appeal a final decision on a PMA or 510(k) or an
A l fi l d i i
IDE disapproval
• Agreement or determination meeting
g g
Health Care אנליזה וניתוח חברות
January 2010
50. In Summary
Regulatory Aff i i about claiming
R g l t Affairs is b t l i i g
and branding
It is the umbrella that covers the Company
activities from early development through
y p g
production and up to post-marketing activities.
Health Care אנליזה וניתוח חברות
January 2010
52. The Key to Market Penetration
y
A breakthrough technology is great but does not
ensure
ens re market s ccess
success
Regulatory approvals are meaningful milestones
•In creating value for strategic agreements
and funding
•In entrance to the market
Clinical evidence (data) is the leading force
to successful market penetration and
positioning
Health Care אנליזה וניתוח חברות
January 2010
53. Clinical Strategy
gy
Post-market
Post market
.
.
.
Study # 3
Study #2
FIM
Investigational/pre-market
Health Care אנליזה וניתוח חברות
January 2010
55. Key Players in
Strategic Pl
St t gi Planning
i g
A Multidisciplinary team from:
Management
Medical practice (SAB)
Clinical
Regulatory
g y
Biostatistical
Marketing and Reimbursement
R&D
Health Care אנליזה וניתוח חברות
January 2010
56. Clinical Strategy
Need for premarket clinical data?
• Yes - for a PMA route
• No and Yes – for a 510(k) route
No – all aspects of safety and effectiveness are
covered by SE rationale and pre clinical
performance tests
Yes – There are still safety and efficacy aspects
not proven by SE and pre clinical tests
b d li i l
Health Care אנליזה וניתוח חברות
January 2010
57. Clinical Strategy
Need for valid postmarket clinical data?
Yes!
For Postmarket surveillance (mainly for PMAs)
For i
F scientific publications
ifi bli i
For market penetration
For reimbursement
For
F a revised intended use
i di t d d
Health Care אנליזה וניתוח חברות
January 2010
58. Hierarchy of Medical
Scientific E id
S i tifi Evidence
Randomized
Controlled
Trial
T i l
Observational Trial
Case-control
Case control
Cohort
Descriptive study
p y
Physiologic study Case
series Expert opinion
Ref: 2010 ICI Meeting, Andrew Farb MD Interventional Cardiology Devices Branch, Office of Device Evaluation
Meeting Farb, MD, Branch
Health Care אנליזה וניתוח חברות
January 2010
59. Clinical Strategy
gy
Premarket Phase
• Pilot Pivotal OR One study
• US and OUS sites/ investigators/data
d it / i ti t /d t
• Type of medical institute/s
yp
If hospitals – referral centers or others
• Type of investigators
Opinion leader, Experienced
practitioner, Regular practitioner
Health Care אנליזה וניתוח חברות
January 2010
60. Clinical Strategy
gy
Postmarket Phase
• Postmarket surveillance (PMA) and long-term
observations
• First In Man (510(k)) - confirmatory/field
• Market penetration
• S i tifi publications
Scientific bli ti
• Reimbursement
Health Care אנליזה וניתוח חברות
January 2010
61. Clinical Study Design
Critical El
C iti l Elements
t
• Type of study
Single arm or randomized
Equivalency (as good as) or Superiority (better
than)
• Study objectives and endpoints
Safety,
Safety Performance and/or Efficacy,
Efficacy
Usability, Quality of Life
• Target population (Eligibility Criteria)
Health Care אנליזה וניתוח חברות
January 2010
62. Critical Decisions in Study
Management
Health Care אנליזה וניתוח חברות
January 2010
64. Site Selection
IP
Laws of
Country
Costs
Scientific
Publications
Location /
Market
Availability
Personnel &
Facilities Regulatory
Expected subjects eligibility
subjects-
Health Care אנליזה וניתוח חברות
January 2010
65. Financial Aspects
Costs of clinical study are mainly based on:
1. Sample size (No of subjects)
2. The experimented procedure
3. Requested clinical assessments (i
3 R d li i l (imaging, l b
i lab.
tests, etc.) & medications
4.
4 Number of follow-up visits
5. Required site participating personnel
6. Requested presence of sponsor personnel
q p p p
(technical, clinical)
7. Costs for ethical committee
8. Hospital overhead
8 H it l h d
9. Monitoring, data management and analysis
Health Care אנליזה וניתוח חברות
January 2010
66. Some Common Pitfalls
• Bad study design
• Inappropriate selection of sites and/or investigators
• Incomplete and/or inappropriate study management
tools (procedures, logs CRFs…)
• Using under-qualified clinical research personnel
( p
(sponsor and/or site)
)
• Poor compliance with GCP– not only necessary for
regulatory reasons b also to reduce the company’s
l but l d h ’
risk from potential adverse publicity and lawsuits
Health Care אנליזה וניתוח חברות
January 2010
67. Study Management
Monitoring
Inadequate monitoring continues to be the top
deficiency cited in FDA i
d fi i i di inspections of sponsors
i f
R f B ildi g Q lit i t D i T il P t 2 – M
Ref: Building Quality into Device Trails, Part Marcarelli M Et l 2006
lli M. Etal,
Health Care אנליזה וניתוח חברות
January 2010
68. Study Management
Investigator Compliance
The regulations require sponsors to bring
noncompliant investigators into compliance
R f B ildi g Q lit i t D i T il P t 2 – M
Ref: Building Quality into Device Trails, Part Marcarelli M Et l 2006
lli M. Etal,
Health Care אנליזה וניתוח חברות
January 2010
69. To Sum Up
Valid Cli i l D t i
V lid Clinical Data is a Composite Result of:
C it R lt f
(1) Team Work
(2) Pre Pl
P Planned Global Clinical Strategy
d Gl b l Cli i l S
(3) Well Designed St d /i
W ll D i d Study/ies
(4) Closely controlled implementation
Health Care אנליזה וניתוח חברות
January 2010
70. Thank You!!!
Moshe Aviv Tower, 34th, Floor
7 Jabotinsky Street, Ramat Gan
E-mail: biomedical@ebms.co.il
Tel: 03-6123281
Health Care אנליזה וניתוח חברות
January 2010