Life sciences law
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| Hauptverfasser: | , |
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| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Zürich ; St. Gallen
Dike
[2019]
Baden-Baden Nomos [2019] |
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| 245 | 1 | 0 | |a Life sciences law |c Barbara Schroeder de Castro Lopes, Judith Schallnau |
| 264 | 1 | |a Zürich ; St. Gallen |b Dike |c [2019] | |
| 264 | 1 | |a Baden-Baden |b Nomos |c [2019] | |
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| 653 | |a Life Sciences Law | ||
| 653 | |a Life Sciences | ||
| 653 | |a Lebenswissenschaften | ||
| 653 | |a Bioethik | ||
| 653 | |a Pharmarecht | ||
| 653 | |a Gesundheitsrecht | ||
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Datensatz im Suchindex
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|---|---|
| adam_text | SUMMARY O F CONTENTS
PREFACE III
FOREWORD VII
SUMMARY OF CONTENTS IX
TABLE OF CONTENTS XI
LIST OF ABBREVIATIONS XXI
BIBLIOGRAPHY XXXIII
CHAPTER 1: INTRODUCTION 1
§ 1 WHAT IS LIFE SCIENCES LAW? 1
§ 2 STRUCTURE OF THE BOOK 1
§ 3 KEY LEGAL ISSUES IN LIFE SCIENCES AT A GLANCE 3
CHAPTER 2: RESEARCH AND INNOVATION 6
§ 4 SWITZERLAND AS A RESEARCH LOCATION 6
§ 5 DISCOVERY AND PROTOTYPES 20
§ 6 TECHNOLOGY TRANSFER 24
§ 7 RESEARCH WITH MICROORGANISMS 26
§ 8 HUMAN RESEARCH 33
CHAPTER 3: MARKET ACCESS 70
§ 9 OVERVIEW OF THE LEGISLATIVE FRAMEWORK 70
§ 10 MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS 82
§ 11 CONFORMITY ASSESSMENT FOR MEDICAL DEVICES 93
§12 PRICING AND REIMBURSEMENT 105
CHAPTER 4: MARKET-RELATED ACTIVITIES 117
§13 MANUFACTURING 118
§14 DISTRIBUTION 123
§15 MARKET SURVEILLANCE AND VIGILANCE 135
§16 INTERNATIONAL TRADE: IMPORT AND EXPORT 141
§17 PRODUCT LIABILITY 153
CHAPTER 5: CROSS-CUTTING ISSUES IN LIFE SCIENCES LAW 160
§18 INTELLECTUAL PROPERTY 160
§ 19 COMMERCIAL CONTRACTS 216
§ 20 DISPUTE RESOLUTION 243
§ 21 INCORPORATION AND FUNDRAISING 264
§22 COMPETITION LAW 272
§ 23 DATA PROTECTION AND DATA TRANSPARENCY 284
CHAPTER 6: SELECTED LEGAL ISSUES IN LIFE SCIENCES IN THE USA
AND CHINA 298
§ 24 PROTECTING PHARMACEUTICALS IN THE
UNITED STATES 298
§ 25 REGULATORY FRAMEWORK OF DRUG ENTRY TO CHINA 304
GLOSSARY 309
TABLE O F CONTENTS
PREFACE III
FOREWORD VII
SUMMARY OF CONTENTS IX
TABLE OF CONTENTS XI
LIST OF ABBREVIATIONS XXI
BIBLIOGRAPHY XXXIII
CHAPTER 1: INTRODUCTION 1
§ 1 WHAT IS LIFE SCIENCES LAW? 1
§ 2 STRUCTURE OF THE BOOK 1
§ 3 KEY LEGAL ISSUES IN LIFE SCIENCES AT A GLANCE 3
CHAPTER 2: RESEARCH AND INNOVATION 6
§ 4 SWITZERLAND AS A RESEARCH LOCATION 6
1. POLICY FRAME AND STAKEHOLDERS 6
2. OVERVIEW: THE FRAMEWORK OF SWISS RESEARCH
AND TECHNOLOGY LEGISLATION IN LIFE SCIENCES 8
3. RESEARCH AND INNOVATION FUNDING 13
A) PUBLIC FUNDING 14
AA) NATIONAL 14
BB) EUROPEAN UNION 15
B) PRIVATE FUNDING 19
§ 5 DISCOVERY AND PROTOTYPES 20
1. PHARMA/BIOTECH 20
2. MEDICAL DEVICES 22
§ 6 TECHNOLOGY TRANSFER 24
1. TECHNOLOGY TRANSFER OFFICES 24
2. MAIN INSTRUMENTS OF TECHNOLOGY TRANSFER 25
§ 7 RESEARCH WITH MICROORGANISMS 26
1. BIOSAFETY IN GENE TECHNOLOGY AND DIAGNOSTIC LABORATORIES 26
A) BIOSAFETY LEGISLATION IN SWITZERLAND FOR ACTIVITIES
IN CONTAINED SYSTEMS 26
B) RISK DETERMINATION AND ASSESSMENT ACCORDING
TO THE CONTAINO 27
2. BIOSECURITY 29
3. BIODIVERSITY: ACCESS AND BENEFIT SHARING 30
§ 8 HUMAN RESEARCH 33
1. THE SWISS LEGAL FRAMEWORK 34
A) THE HUMAN RESEARCH ACT 34
B) OTHER REGULATIONS RELEVANT FOR HUMAN RESEARCH 36
2. TYPES OF HUMAN RESEARCH PROJECTS 37
A) CLINICAL TRIALS 37
AA) WHAT IS A CLINICAL TRIAL? 38
BB) CLINICAL TRIALS IN PHARMA/BIOTECH AND MEDTECH:
COMMON FRAMEWORK AND DIFFERENCES 38
CC) PRECLINICAL PHASE: IN VITRO AND IN VIVO TESTING 39
DD) CLINICAL TRIALS WITH MEDICINAL PRODUCTS 43
EE) CLINICAL TRIALS WITH MEDICAL DEVICES 45
B) OTHER (NON-DINICAL) HUMAN RESEARCH PROJECTS 47
3. KEY PRINCIPLES FOR ALL HUMAN RESEARCH PROJECTS 47
A) SCIENTIFIC RELEVANCE 48
B) RIGHT TO SELF-DETERMINATION AND INFORMED CONSENT
OF THE RESEARCH PARTICIPANT 49
C) SUBSIDIARITY AND PROPORTIONALITY 50
D) ADDITIONAL REQUIREMENTS FOR STUDIES INVOLVING
VULNERABLE PERSONS 51
E) PRIOR INDEPENDENT ASSESSMENT 51
4. WHO IS INVOLVED IN HUMAN RESEARCH PROJECTS? 53
5. REQUESTING APPROVAL FOR A HUMAN RESEARCH PROJECT:
PRACTICAL GUIDANCE 54
A) CLINICAL TRIAL CATEGORIES 54
AA) CLINICAL TRIALS WITH MEDICINAL PRODUCTS 54
BB) CLINICAL TRIALS WITH MEDICAL DEVICES 56
B) CATEGORIES OF OTHER (NON-CLINICAL) HUMAN RESEARCH
PROJECTS 57
C) HOW TO SUBMIT AN APPROVAL REQUEST TO THE SWISS
AUTHORITIES 57
6. CONDUCTING A HUMAN RESEARCH PROJECT: ENSURING SAFETY
OF THE RESEARCH PARTICIPANTS 58
A) GENERAL NOTIFICATION AND REPORTING REQUIREMENTS 59
B) ADVERSE EVENT DOCUMENTATION AND NOTIFICATION 59
C) INSPECTIONS CARRIED OUT BY SWISSMEDIC 60
7. LIABILITY IN CASE OF DAMAGE SUFFERED BY RESEARCH
PARTICIPANTS 60
8. THE NEW EU REGULATION ON CLINICAL TRIALS WITH
MEDICINAL PRODUCTS 63
9. THE NEW EU REGULATIONS ON CLINICAL EVIDENCE FOR
MEDICAL DEVICES 65
A) CLINICAL EVALUATION 65
B) CLINICAL INVESTIGATION 66
C) EQUIVALENCE ( LITERATURE ROUTE ) 67
D) PERFORMANCE EVALUATION AND PERFORMANCE STUDIES
WITH IVDS 68
E) AMENDMENT OF THE SWISS HRA 68
CHAPTER 3: MARKET ACCESS 70
§ 9 OVERVIEW OF THE LEGISLATIVE FRAMEWORK 70
1. THERAPEUTIC PRODUCT ACT: CONCEPT, RECENTLY ENACTED
AND FORTHCOMING AMENDMENTS 70
2. OTHER LEGISLATION OF RELEVANCE FOR MARKET ACCESS OF
THERAPEUTIC PRODUCTS 74
3. PRODUCT CLASSIFICATION AND PRACTICAL CONSEQUENCES 75
A) MEDICINAL PRODUCTS VS MEDICAL DEVICES 75
B) MEDICINAL PRODUCTS/MEDICAL DEVICES IN RELATION
TO OTHER PRODUCT GROUPS 79
C) EXCURSUS: MHEALTH - STANDALONE SOFTWARE AS
MEDICAL DEVICE 80
§ 10 MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS 82
1. MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS
IN SWITZERLAND 82
A) CRITERIA FOR MARKETING AUTHORISATION 82
B) MARKETING AUTHORISATION PROCEDURES 83
C) REGULATORY INCENTIVES 87
D) PAEDIATRIC AND ORPHAN MEDICINES 87
AA) PAEDIATRIC MEDICINES 87
BB) ORPHAN DRUGS 88
2. MARKETING AUTHORISATION FOR MEDICINAL PRODUCTS IN THE EU 90
§ 11 CONFORMITY ASSESSMENT FOR MEDICAL DEVICES 93
1. BASIC RULES AND RECENT LEGISLATIVE CHANGES 93
2. COMMON CONCEPTS FOR ALL MEDICAL DEVICES 97
3. SPECIFIC PROVISIONS FOR ACTIVE IMPLANTABLE
AND CLASSICAL MEDICAL DEVICES 99
4. SPECIFIC PROVISIONS FOR IN VITRO DIAGNOSTICS 103
§12 PRICING AND REIMBURSEMENT 105
1. POLICY CONSIDERATIONS 105
2. PRICING AND REIMBURSING MEDICINAL PRODUCTS 107
A) MEDICINES ELIGIBLE FOR REIMBURSEMENT 107
B) ADMISSION PROCEDURE AND DECISION 109
C) REVIEW OF ADMISSION CRITERIA 111
AA) PRE-MARKET STAGE/NON-LISTED MEDICINES 112
BB) FIRST ADMISSION, TRIENNIAL REVIEWS,
NEW INDICATION, NEW PACKAGING 112
CC) AFTER PATENT EXPIRY 113
D) FOREIGN REIMBURSEMENT SYSTEMS AND NEW
APPROACHES TO PHARMA PRICING 113
3. PRICING AND REIMBURSING MEDICAL DEVICES 114
CHAPTER 4: MARKET-RELATED ACTIVITIES 117
§13 MANUFACTURING 118
1. MANUFACTURING MEDICINAL PRODUCTS 118
A) REGULATORY ISSUES 118
AA) MANUFACTURING AUTHORISATION 118
BB) GOOD MANUFACTURING PRACTICE 118
CC) ENVIRONMENTAL ISSUES 119
B) COMMERCIAL AND TECHNICAL ASPECTS 120
2. MANUFACTURING MEDICAL DEVICES 120
A) REGULATORY ISSUES 120
AA) NO AUTHORISATION REQUIRED 120
BB) ENVIRONMENTAL ISSUES 122
B) COMMERCIAL AND TECHNICAL ASPECTS 122
§14 DISTRIBUTION 123
1. DISTRIBUTING MEDICINAL PRODUCTS 123
A) DISTRIBUTION CHANNELS 123
B) WHOLESALE AUTHORISATION 123
C) GOOD DISTRIBUTION PRACTICE 124
D) RETAIL AUTHORISATION, DISPENSING DOCTORS AND
ONLINE PHARMACIES 124
E) SUPPLY CATEGORIES 125
F) ADVERTISING 127
G) INTEGRITY AND TRANSPARENCY 128
H) ORGANISING DISTRIBUTION - COMMERCIAL ASPECTS 131
2. DISTRIBUTING MEDICAL DEVICES 131
A) DISTRIBUTION CHANNELS 131
B) NO AUTHORISATION REQUIRED 131
C) DISTANCE SALES/E-COMMERCE 132
D) REGULATORY RESPONSIBILITIES OF ECONOMIC OPERATORS
IN THE SUPPLY CHAIN AND DEVICE TRACEABILITY 133
E) ADVERTISING 134
F) INTEGRITY AND TRANSPARENCY 134
G) ORGANISING DISTRIBUTION - COMMERCIAL ASPECTS 135
§15 MARKET SURVEILLANCE AND VIGILANCE 135
1. MARKET SURVEILLANCE 135
2. MARKET SURVEILLANCE TOOLS 136
3. PHARMACOVIGILANCE AND SAFETY RISK MANAGEMENT 137
A) PHARMACOVIGILANCE PLANNING 138
B) PERIODIC REPORTING AND SPONTANEOUS NOTIFICATION
REQUIREMENTS 138
4. MATERIOVIGILANCE AND MEDICAL DEVICES
OBSERVATION SYSTEMS 140
§16 INTERNATIONAL TRADE: IMPORT AND EXPORT 141
1. THE SIGNIFICANCE OF THE SWITZERLAND-EU MUTUAL
RECOGNITION AGREEMENT 142
A) SIGNIFICANCE FOR THE PHARMACEUTICAL INDUSTRY 142
B) SIGNIFICANCE FOR THE MEDTECH INDUSTRY 144
C) MARKET ACCESS FOR A NON-EUROPEAN MEDICAL
DEVICE MANUFACTURER 147
D) WHAT ABOUT THE RELATIONSHIP BETWEEN SWITZERLAND
AND THE EEA/EFTA COUNTRIES? 147
2. IMPORT AND EXPORT AUTHORISATIONS FOR MEDICINAL
PRODUCTS - EU AND NON-EU 148
3. EXPORTING MEDICAL DEVICES OUTSIDE EUROPE 149
4. PARALLEL TRADE 150
5. COUNTERFEIT AND FALSIFIED MEDICINES AND
MEDICAL DEVICES 151
§17 PRODUCT LIABILITY 153
1. DOCTOR-PATIENT RELATIONSHIP 153
2. LIABILITY OF THE MANUFACTURER TOWARDS THE PATIENT 154
A) INTRODUCTION 154
B) PARTICULAR ISSUES AND DEVELOPMENTS IN RELATION
TO MEDICINES 155
C) PARTICULAR ISSUES AND DEVELOPMENTS IN RELATION
TO MEDICAL DEVICES 157
CHAPTER 5: CROSS-CUTTING ISSUES IN LIFE SCIENCES LAW 160
§18 INTELLECTUAL PROPERTY 160
1. INTRODUCTION 160
2. SELECTED IP LEGISLATION AND INSTITUTIONS 161
3. PATENTS 163
A) THE LEGAL FRAMEWORK 163
B) DEFINITION, EXAMPLES AND SCOPE OF PATENT PROTECTION 164
C) FORMAL REQUIREMENTS - FILING A PATENT APPLICATION 165
AA) WHERE TO FILE 165
BB) THE PATENT APPLICATION 167
CC) PRIORITY 169
DD) PATENT SEARCHES 169
EE) APPLICATION STRATEGIES AND PATENT PORTFOLIO
MANAGEMENT 170
D) SUBSTANTIVE REQUIREMENTS - PATENTABILITY CRITERIA 172
AA) GENERAL CONDITIONS 172
BB) EXCEPTIONS TO PATENTABILITY 174
E) EFFECTS OF THE PATENT 176
AA) GENERAL RULE 176
BB) EXCEPTIONS 176
CC) EXHAUSTION AND PARALLEL IMPORTS 178
DD) PRIOR USE 178
F) EXTENDING PATENT TERM 179
AA) SUPPLEMENTARY PROTECTION CERTIFICATE (SPC) 180
BB) PAEDIATRIC EXTENSION 183
CC) PAEDIATRIC CERTIFICATE 185
G) DATA EXCLUSIVITY AND MARKET EXCLUSIVITY 186
H) INTEGRATED PROTECTION STRATEGIES 188
4. TRADEMARKS 189
A) THE LEGAL FRAMEWORK 190
B) DEFINITION, EXAMPLES AND SCOPE OF TRADE MARK
PROTECTION 190
C) FORMAL REQUIREMENTS - TRADE MARK REGISTRATION 192
D) TRADE MARK SEARCH AND CREATION 193
AA) OVERVIEW 193
BB) CONSIDERATIONS FOR THE TRADE MARK SELECTION
PROCESS 193
CC) TRADE MARK PORTFOLIO MANAGEMENT 194
E) SUBSTANTIVE REQUIREMENTS - ABSOLUTE GROUNDS
TO REFUSE TRADE MARK REGISTRATION 195
AA) ABSOLUTE GROUNDS FOR REFUSAL - OVERVIEW 195
BB) INTERNATIONAL NON-PROPRIETARY NAMES
(INNS) - SIGNS THAT ARE IN THE PUBLIC DOMAIN 196
F) SUBSTANTIVE REQUIREMENTS - RELATIVE GROUNDS
TO REFUSE TRADE MARK REGISTRATION 198
G) REGULATORY APPROVAL OF MEDICINAL PRODUCT NAME 199
H) TRADE MARK TERM 200
I) TRADE MARK USE 201
5. DESIGN RIGHTS 201
A) THE LEGAL FRAMEWORK 201
B) DEFINITION, SCOPE AND EXAMPLES 201
C) DESIGN REGISTRATION 202
D) DURATION OF DESIGN PROTECTION 203
E) DESIGNS AND OTHER IPR 203
6. COPYRIGHT 204
7. DATABASE RIGHTS 205
8. CONFIDENTIAL TRADE SECRETS/KNOW-HOW 205
9. INTELLECTUAL PROPERTY ENFORCEMENT 206
A) GENERAL OVERVIEW - PATENTS, TRADE MARKS, DESIGN,
COPYRIGHT ENFORCEMENT 208
B) PATENT LITIGATION 214
C) DOMAIN NAME CYBERSQUATTING 215
§19 COMMERCIAL CONTRACTS 216
1. INTRODUCTION 216
2. GENERAL CONSIDERATIONS FOR NEGOTIATING AND DRAFTING
CONTRACTS 217
A) CLARITY 217
B) TRANSPARENCY 218
C) BALANCED RELATIONSHIP 218
D) LEVEL OF DETAIL 218
3. SELECTED GENERAL CONTRACT TERMS 218
A) PARTIES, PREAMBLE, DEFINITIONS 219
B) TERM/TERMINATION 219
C) CONFIDENTIALITY 219
D) LIABILITY/INDEMNIFICATION 220
E) REPRESENTATIONS AND WARRANTIES 220
F) INTELLECTUAL PROPERTY RIGHTS 220
G) PROVISIONS ON COSTS, BUDGET, PAYMENT SCHEDULE,
INVOICING 221
H) APPLICABLE LAW 221
I) DISPUTE RESOLUTION 221
4. NON-DISCLOSURE AGREEMENTS 222
5. MATERIAL TRANSFER AGREEMENTS 222
6. FEASIBILITY STUDY AGREEMENTS 223
7. OPTION AGREEMENTS 224
8. RESEARCH AND DEVELOPMENT AGREEMENTS 225
A) COLLABORATIVE RESEARCH 226
B) CONTRACT RESEARCH 229
C) AGREEMENTS RELATED TO CLINICAL TRIALS 229
AA) CLINICAL RESEARCH ORGANISATION MASTER SERVICES
AGREEMENT 229
BB) CLINICAL TRIAL AGREEMENT/CONTRACT FOR CONDUCTING
CLINICAL INVESTIGATION IN MEDICAL DEVICES 231
9. LICENCE AGREEMENTS 232
A) LEGAL FRAMEWORK 233
B) CATEGORIES OF LICENCES 233
C) CONTRACT PROVISIONS 235
10. ASSIGNMENTS 236
11. MANUFACTURING AGREEMENTS 237
12. DISTRIBUTION AND SUPPLY AGREEMENTS 239
§ 20 DISPUTE RESOLUTION 243
1. PUBLIC LAW LITIGATION 243
A) LEGAL REMEDIES AGAINST A DECISION ISSUED BY A
CANTONAL AUTHORITY 244
B) LEGAL REMEDIES AGAINST A DECISION ISSUED BY A
FEDERAL AUTHORITY 245
2. CIVIL LAW AND COMMERCIAL LITIGATION 246
3. PATENT LITIGATION 249
4. MEDIATION AND ARBITRATION 250
A) MEDIATION 251
B) ARBITRATION 253
C) BENEFITS OF MEDIATION AND ARBITRATION 254
D) HOW A MEDIATION RUNS 259
E) HOW AN ARBITRATION RUNS 260
F) DISPUTE RESOLUTION CLAUSE EXAMPLE 262
§ 21 INCORPORATION AND FUNDRAISING 264
1. PREPARATORY STAGE 265
2. INCORPORATION 266
3. FUNDRAISING AND FUNDING CYCLE 267
A) INVESTOR PITCHES AND PREPARATION FOR FUNDRAISING 267
B) FROM SEED FUNDING TO EXIT 268
§ 22 COMPETITION LAW 272
1. OVERVIEW 272
A) BASIC PRINCIPLES AND ENFORCEMENT AUTHORITIES 272
B) PARTICULARITIES RELATED TO THE PHARMACEUTICAL SECTOR 276
2. SELECTED ISSUES AND CASE EXAMPLES 276
A) COMPETITION ISSUES ALONG THE PHARMACEUTICAL
VALUE CHAIN 276
B) SCOPE OF COMPETITION LAW 277
C) MARKET DEFINITION 278
D) CARTELS 279
E) ISSUES AT THE INTERFACE OF IP, REGULATORY AND
COMPETITION LAW 279
AA) RECENT CASE LAW OF EUROPEAN COURTS 280
BB) BLOCK EXEMPTION REGULATIONS (BERS) 282
CC) PARALLEL IMPORTS 283
§ 23 DATA PROTECTION AND DATA TRANSPARENCY 284
1. THE LEGAL FRAMEWORK IN SWITZERLAND 287
A) OVERVIEW 287
B) BIOMEDICAL RESEARCH WITH BIOLOGICAL MATERIAL,
GENETIC AND NON-GENETIC HEALTH-RELATED DATA 288
2. THE NEW EU REGULATIONS 291
A) DATA PROTECTION: THE GENERAL DATA PROTECTION
REGULATION AND THE REGULATION ON CLINICAL TRIALS 291
AA) THE EU-GDPR: GENERAL OVERVIEW 291
BB) ISSUES OF PARTICULAR RELEVANCE IN LIFE SCIENCES 293
B) DATA TRANSPARENCY: THE EU REGULATION
ON CLINICAL TRIALS 296
CHAPTER 6: SELECTED LEGAL ISSUES IN LIFE SCIENCES IN THE USA
AND CHINA 298
§ 24 PROTECTING PHARMACEUTICALS IN THE UNITED STATES 298
1. INTRODUCTION 298
2. PATENTS 298
A) UNITED STATES PATENT PROTECTION 298
B) ENFORCING PATENTS 299
3. FDA REGULATORY EXCLUSIVITY 301
A) OVERVIEW 301
B) SMALL MOLECULE DRUGS 301
C) BIOLOGICAL PRODUCTS 303
§ 25 REGULATORY FRAMEWORK OF DRUG ENTRY TO CHINA 304
1. INTRODUCTION 304
A) KEY REGULATORY BODIES 304
B) REGULATORY FRAMEWORK 305
2. CLINICAL TRIALS 305
3. MANUFACTURING 306
4. DRUG IMPORTATION 307
GLOSSARY 309
|
| any_adam_object | 1 |
| author | Schroeder de Castro Lopes, Barbara Schallnau, Judith |
| author_GND | (DE-588)1176211102 (DE-588)1176216945 |
| author_facet | Schroeder de Castro Lopes, Barbara Schallnau, Judith |
| author_role | aut aut |
| author_sort | Schroeder de Castro Lopes, Barbara |
| author_variant | d c l b s dclb dclbs j s js |
| building | Verbundindex |
| bvnumber | BV045481599 |
| classification_rvk | PJ 3260 |
| ctrlnum | (OCoLC)1078953209 (DE-599)DNB1163829218 |
| discipline | Rechtswissenschaft |
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| genre_facet | Lehrbuch |
| geographic | Schweiz (DE-588)4053881-3 gnd |
| geographic_facet | Schweiz |
| id | DE-604.BV045481599 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-10T08:19:16Z |
| institution | BVB |
| institution_GND | (DE-588)117513-0 |
| isbn | 9783038910251 9783848754045 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-030866661 |
| oclc_num | 1078953209 |
| open_access_boolean | |
| owner | DE-703 DE-739 DE-M382 DE-19 DE-BY-UBM |
| owner_facet | DE-703 DE-739 DE-M382 DE-19 DE-BY-UBM |
| physical | XLVI, 323 Seiten Diagramme |
| publishDate | 2019 |
| publishDateSearch | 2019 |
| publishDateSort | 2019 |
| publisher | Dike Nomos |
| record_format | marc |
| spelling | Schroeder de Castro Lopes, Barbara Verfasser (DE-588)1176211102 aut Life sciences law Barbara Schroeder de Castro Lopes, Judith Schallnau Zürich ; St. Gallen Dike [2019] Baden-Baden Nomos [2019] XLVI, 323 Seiten Diagramme txt rdacontent n rdamedia nc rdacarrier Arzneimittelrecht (DE-588)4003139-1 gnd rswk-swf Biotechnologie (DE-588)4069491-4 gnd rswk-swf Medizinprodukterecht (DE-588)7705986-4 gnd rswk-swf Schweiz (DE-588)4053881-3 gnd rswk-swf Life Sciences Law Life Sciences Lebenswissenschaften Bioethik Pharmarecht Gesundheitsrecht (DE-588)4123623-3 Lehrbuch gnd-content Schweiz (DE-588)4053881-3 g Biotechnologie (DE-588)4069491-4 s Arzneimittelrecht (DE-588)4003139-1 s Medizinprodukterecht (DE-588)7705986-4 s DE-604 Schallnau, Judith Verfasser (DE-588)1176216945 aut Nomos Verlagsgesellschaft (DE-588)117513-0 pbl X:MVB text/html http://deposit.dnb.de/cgi-bin/dokserv?id=3a2056c45d6f4bcd8d0bf395fa5b42b4&prov=M&dok_var=1&dok_ext=htm Inhaltstext DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=030866661&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Schroeder de Castro Lopes, Barbara Schallnau, Judith Life sciences law Arzneimittelrecht (DE-588)4003139-1 gnd Biotechnologie (DE-588)4069491-4 gnd Medizinprodukterecht (DE-588)7705986-4 gnd |
| subject_GND | (DE-588)4003139-1 (DE-588)4069491-4 (DE-588)7705986-4 (DE-588)4053881-3 (DE-588)4123623-3 |
| title | Life sciences law |
| title_auth | Life sciences law |
| title_exact_search | Life sciences law |
| title_full | Life sciences law Barbara Schroeder de Castro Lopes, Judith Schallnau |
| title_fullStr | Life sciences law Barbara Schroeder de Castro Lopes, Judith Schallnau |
| title_full_unstemmed | Life sciences law Barbara Schroeder de Castro Lopes, Judith Schallnau |
| title_short | Life sciences law |
| title_sort | life sciences law |
| topic | Arzneimittelrecht (DE-588)4003139-1 gnd Biotechnologie (DE-588)4069491-4 gnd Medizinprodukterecht (DE-588)7705986-4 gnd |
| topic_facet | Arzneimittelrecht Biotechnologie Medizinprodukterecht Schweiz Lehrbuch |
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| work_keys_str_mv | AT schroederdecastrolopesbarbara lifescienceslaw AT schallnaujudith lifescienceslaw AT nomosverlagsgesellschaft lifescienceslaw |