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    <pre style="white-space:pre-line"><code>129 3. Legal basis and relevant guidelines

130 This Guideline should be read in conjunction with the introduction and general principles of Annex I to
131 Directive 2001/83/EC, as amended, and all other relevant EU and ICH guidelines. These include, but
132 are not limited to:

133 ï‚· ICH topic E2A Clinical Safety Data Management: Definitions and Standards for Expedited
134 Reporting (CPMP/ICH/377/95)

135 ï‚· ICH topic E8 General Considerations for Clinical Trials (CPMP/ICH/291/95)

136 ï‚· ICH topic E11 Clinical Investigation of Medicinal Products in Paediatric Population

137 ï‚· ICH E7 Studies in Support of Special Populations: Geriatrics Q&A
138 (EMA/CHMP/ICH/604661/2009)

139 ï‚· Note for Guidance on Good Clinical Safety Data Management: Definitions and Standards for
140 Expedited Reporting (CPMP/ICH/377/95)

141 ï‚· ICH Note for Guidance on Planning Pharmacovigilance Activities (CPMP/ICH/5716/03)

142 ï‚· Guideline on Influenza Vaccines; Non-clinical and Clinical Module.
143 (EMA/CHMP/VWP/457259/2014)

144 ï‚· Guideline on quality, non-clinical and clinical aspects of live recombinant viral vectored
145 vaccines. (EMA/CHMP/VWP/141697/2009)

146 ï‚· ICH Q2 (R1) Validation of analytical procedures: text and methodology (CPMP/ICH/381/95)

147 ï‚· ICH topic E9 Statistical principles for clinical trials â€“ Note for Guidance on Statistical Principles
148 for Clinical Trials (CPMP/ICH/363/96)

149 ï‚· Points to Consider on Missing Data (CPMP/EWP/1776/99)

150 ï‚· Guideline on the Choice of the Non-Inferiority Margin (EMEA/CPMP/EWP/2158/99)

151 ï‚· Points to Consider on Switching between Superiority and Non-Inferiority (CPMP/EWP/482/99)

152 ï‚· Points to Consider on Multiplicity Issues in Clinical Trials (CPMP/EWP/908/99)

153 ï‚· Points to consider on application of 1. Meta-analyses 2. One pivotal study
154 (CPMP/EWP/2330/99)

155 ï‚· Guidance on format of the risk-management plan in the European Union
156 (EMA/PRAC/613102/2015 Rev.2 accompanying GVP Module V Rev.2)

157 ï‚· Guideline on Risk Management Systems for Medicinal Products for Human use (EMEA/CHMP
158 96286/2005)

159 ï‚· Guideline on good pharmacovigilance practices (GVP) - Product- or Population-Specific
160 Considerations I: Vaccines for prophylaxis against infectious diseases (EMA/488220/2012 Corr)

161 ï‚· Guideline on good pharmacovigilance practices (GVP) Annex I - Definitions (EMA/876333/2011
162 Rev 4)

163 ï‚· Guideline on good pharmacovigilance practices: Module V â€“ Risk management systems
164 (EMA/838713/2011 Rev 2).

Guideline on clinical evaluation of vaccines
EMEA/CHMP/VWP/164653/05 Rev. 1

                                              Page 5/21</code></pre>
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