INTRODUCTION

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on: 
Donnerstag, April 18, 2024

REFERENCES ....................................................................................................................................... 14

Key Points: 
    • REFERENCES ....................................................................................................................................... 14

      29

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 3/14

      30

      EXECUTIVE SUMMARY

      31
      32
      33
      34
      35
      36

      This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

      37

      1.

    • Due to the inherent
      complexity of medicinal plants and herbal substances the quality of these starting materials requires an
      adequate quality assurance system for the collection and/or cultivation, harvest, and primary
      processing.
    • (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
      types could have several problems and advantages.
    • The used cultivation method may be dependent on
      the final application of the herbal medicinal product.
    • primary processing of herbal substances that are used for the preparation of herbal medicinal products.
    • medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
      stages of cultivation, collection, processing and storage.
    • their preparations are exposed to a large number of environmental contaminants of both biotic and
      abiotic origin.
    • to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
      Endangered species of Wild Fauna and Flora).
    • https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
      4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
      3

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 5/14

      104

      4.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

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      147
      148
      149

      8.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 7/14

      185

      7.

    • Where possible, stable varieties and cultivars naturally
      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 8/14

      227
      228

      resistant or tolerant to disease should preferably be used.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 9/14

      268
      269
      270
      271
      272
      273

      The application should be carried out only by qualified staff using approved equipment.

    • The following should be noted:

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 10/14

      309
      310

      ?

      311
      312
      313

      ?

      314
      315
      316
      317

      ?

      318
      319
      320

      ?

      321
      322

      ?

      323
      324
      325

      ?

      326
      327
      328

      ?

      Damaged plants or plant parts need to be excluded or limited in accordance with a specific
      pharmacopoeia monograph, where relevant.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 11/14

      347
      348

      directly to the sun (except in cases where there is a specific need) and must be protected from
      rainfall, insect infestation, etc.

    • The label must be clear, permanently fixed and made from

      6

      Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 12/14

      386
      387

      non-toxic material.

    • Certain exudates that have not been subjected to a specific treatment are

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 13/14

      425
      426
      427

      also considered to be herbal substances.

    • European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433

      Are obtained by subjecting herbal substances to treatments such as
      extraction, distillation, expression, fractionation, purification, concentration
      or fermentation.

Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Retrieved on: 
Donnerstag, April 18, 2024
Steps, Union, Patient, CTD, Syndrome, CCI, Local, Disclosure, Toxicity, Process validation, MAH, Clinical trial, IP, RMP, Pharmacovigilance, Cell, Legislation, Annex, Trial of the century, Escherichia coli, Safety, Pediatrics, INTRODUCTION, Documentation, Prevalence, Vital signs, Tablet, Design, Transparency, Conclusion, Pip, Analysis, European Parliament, INN, Record, Quality, Generic, Biology, CMO, Genotoxicity, Composition, CTIS, Uncontrolled, Health care, European Medicines Agency, Prejudice, Committee, Policy, HCP, Animal, Characterization, Cell bank, Fertility, IRB, CMOS, Risk management, Private law, European Pharmacopoeia, Telephone, Research, Good, Data Protection Directive, Ampere-hour, IEC, QP, Human, Personal data, Labelling, Bibliography, Figure, MAA, R4, Institutional review board, Elucidation, Marketing, M4, ChromeOS, Contract research organization, Mental, Impairment, Toxicokinetics, NCA, Independent, Metabolite, Drug, Risk, Metabolism, GMO, Organ, EMA, Common Technical Document, General Data Protection Regulation, Confidentiality, PPD, PI, Language, DRUG, Privacy, Result, Claimed, Medication, Comparison, Ethics, Drive, PD, Narrative, EEA, Developmental toxicity, Saccharomyces cerevisiae, Pharmacopoeia, PIP, MCB, HMA, Physical chemistry, Midol, Particle size, Council, GCP, European Economic Area, Draft, Fermentation, Overview, Justification, Control, Dicarboxylic acid, Pharmacology, WCB, Expert, Immunogenicity, Data, Study, Publication, European, ICH, Element, Analytical procedures (finance auditing), Name, Common, Guideline, Exceptional circumstances, ID, Liver, Chin Na, Toxicology, Protein primary structure, Immunosuppressive drug, Vaccine

See websites for contact details

Key Points: 
    • See websites for contact details
      Heads of Medicines Agencies www.hma.eu
      European Medicines Agency www.ema.europa.eu

      11

      Table of contents

      12

      Abbreviations .............................................................................................. 3

      13

      Definitions ................................................................................................... 4

      14

      1.

    • redaction, masking,

      68

      hiding) in such a manner that the recipient can no longer attribute the resulting information to a data

      69

      subject and make it identifiable.

    • 81

      Contract Manufacturing Organisation (CMO): shall mean an arrangement under which a

      82

      manufacturer provides upstream manufacturing services under contract on behalf of third-party

      83

      pharmaceutical companies.

    • 94

      Protected Personal Data (PPD): shall mean any personal data which should be protected from

      95

      disclosure.

    • ?Finalised? shall mean that the marketing

      102

      authorisation (MA) has been granted or refused or that the MAA has been withdrawn.

    • The application of the general principles laid down in this guidance is without prejudice to

      106

      national rules on transparency.

    • The guidance should be read in conjunction with the relevant applicable

      107

      legislation and case law on transparency and data protection.

    • 117

      This guidance document is intended to apply to information/documents on medicinal products for

      118

      human use, for which the procedure has been finalised under the national, mutual recognition,

      119

      decentralised and centralised procedures.

    • Third

      124

      parties shall be informed or consulted as needed depending on respective national and European legal

      125

      frameworks.

    • 140

      In the following sections, the agreed principles on PD and CCI are presented, including guidance on

      141

      whether such information can be disclosed.

    • EMA/131365/2024

      Page 5/50

      142

      Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior

      143

      to the possible disclosure of the information/documents.

    • Principles on the protection of personal data (PD)

      145

      The protection of PD is enshrined in EU legislation; it is a fundamental right of EU citizens.

    • In

      146

      compliance with the applicable European/national legislation, PD should be anonymised in order to

      147

      avoid the disclosure of the document undermining the privacy and integrity of any individual.

    • EMA/NCA applies a risk-based approach to assess which PD elements are to be

      152

      removed from the information/documents in order to limit the risk of re-identification.

    • are included in the MAA dossier because they have a legally

      164

      defined role or responsibility and it is in the public interest to disclose this data.

    • 168

      Applicants are advised that non-essential information (e.g., personal address, personal phone number)

      169

      should not be included in the MAA dossier.

    • The

      183

      confidentiality of records that could identify subjects should be protected, respecting the privacy and

      184

      confidentiality rules in accordance with the applicable regulatory requirement(s).

    • 185

      The applicant remains responsible for compliance with the relevant legislation in cases where such data

      186

      is inadvertently included in the MAA dossier.

    • 188

      EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

      189

      from the information/documents in order to limit the risk of re-identification.

    • 194

      EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

      195

      from the information/documents in order to limit the risk of re-identification.

    • 205

      Any proposal to consider information as commercially confidential should be properly justified by the

      206

      owner of the information.

    • In this respect, any reference(s) to the risk of that interest being

      209

      undermined should be foreseeable and not purely hypothetical.

    • 210

      Information that is already in the public domain is not considered to be commercially confidential.

    • Information on the Quality and Manufacturing of medicines

      226

      A general principle regarding quality and manufacturing information is that detailed information could

      227

      be considered commercially confidential but general information should be disclosed.

    • 234

      In general, and if not in the public domain, the names of manufacturers or suppliers of the active

      235

      substance or the excipients are considered commercially confidential.

    • 248

      A general description of the type of test methods used and the appropriateness of the specification is

      249

      not commercially confidential.

    • General information on the fermentation and purification process

      259

      is not commercially confidential, although details including operating parameters and specific material

      260

      requirements are commercially confidential.

    • 273

      A general description of the type of test methods used and the appropriateness of the specification is

      274

      not commercially confidential.

    • In general, the data included in clinical trial study reports is considered to be data that can be

      283

      disclosed once PD has been anonymised.

    • 338

      In each module, a non-exhaustive list of information that may be considered protected personal data (PPD) or commercially confidential information

      332
      333

      339

      (CCI) is included.

    • ?

      Direct contact details such as telephone

      Therefore, please refer to the appropriate sub-

      number, fax number, email, postal address,

      modules hereafter for guidance.

    • ?

      Information that may reveal strategic
      (contractual) agreements

      ?

      Any quality information on the clinical batches

      principal investigator

      that might be included here (such as e.g.

    • ?

      Information that may reveal strategic
      (contractual) agreements

      principal investigator

      Study Reports
      5.3.3.3

      as the evaluation of new formulation, innovative

      number, fax number, email, postal

      Paediatric Development Plan (PIP), etc.

    • This may include taking into

      More Than One Study
      5.3.5.4

      Other Clinical Study Reports

      5.3.6

      Reports of Post-Marketing
      Experience

      5.3.7

      Direct identifiers such as name,
      signature, contact details, etc.

Draft guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin - Revision 1

Retrieved on: 
Donnerstag, April 18, 2024

REFERENCES ....................................................................................................................................... 14

Key Points: 
    • REFERENCES ....................................................................................................................................... 14

      29

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 3/14

      30

      EXECUTIVE SUMMARY

      31
      32
      33
      34
      35
      36

      This guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin

      37

      1.

    • Due to the inherent
      complexity of medicinal plants and herbal substances the quality of these starting materials requires an
      adequate quality assurance system for the collection and/or cultivation, harvest, and primary
      processing.
    • (either outdoor, indoor or in greenhouses) should be carefully considered, since each of the mentioned
      types could have several problems and advantages.
    • The used cultivation method may be dependent on
      the final application of the herbal medicinal product.
    • primary processing of herbal substances that are used for the preparation of herbal medicinal products.
    • medicinal plants and herbal substances, ensuring that they are handled appropriately throughout all
      stages of cultivation, collection, processing and storage.
    • their preparations are exposed to a large number of environmental contaminants of both biotic and
      abiotic origin.
    • to existing wildlife habitats and must adhere to CITES (Convention on International Trade in
      Endangered species of Wild Fauna and Flora).
    • https://health.ec.europa.eu/document/download/bd537ccf-9271-4230-bca1-2d...
      4 https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0232...
      3

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 5/14

      104

      4.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 6/14

      147
      148
      149

      8.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 7/14

      185

      7.

    • Where possible, stable varieties and cultivars naturally
      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 8/14

      227
      228

      resistant or tolerant to disease should preferably be used.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 9/14

      268
      269
      270
      271
      272
      273

      The application should be carried out only by qualified staff using approved equipment.

    • The following should be noted:

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 10/14

      309
      310

      ?

      311
      312
      313

      ?

      314
      315
      316
      317

      ?

      318
      319
      320

      ?

      321
      322

      ?

      323
      324
      325

      ?

      326
      327
      328

      ?

      Damaged plants or plant parts need to be excluded or limited in accordance with a specific
      pharmacopoeia monograph, where relevant.

    • Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 11/14

      347
      348

      directly to the sun (except in cases where there is a specific need) and must be protected from
      rainfall, insect infestation, etc.

    • The label must be clear, permanently fixed and made from

      6

      Reflection paper on the use of fumigants (EMEA/HMPC/125562/2006)

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 12/14

      386
      387

      non-toxic material.

    • Certain exudates that have not been subjected to a specific treatment are

      Guideline on Good Agricultural and Collection Practice (GACP) for starting materials of herbal origin
      EMA/HMPC/246816/2005

      Page 13/14

      425
      426
      427

      also considered to be herbal substances.

    • European Pharmacopoeia General Monograph ?HERBAL DRUGS? 07/2017:1433

      Are obtained by subjecting herbal substances to treatments such as
      extraction, distillation, expression, fractionation, purification, concentration
      or fermentation.

ICH E2D(R1) Guideline on post-approval safety data Step 2b - Revision 1

Retrieved on: 
Dienstag, März 12, 2024

The completed comments form should be sent to

Key Points: 
    • The completed comments form should be sent to
      [email protected]
      *For more information please refer to Public consultation explanatory note: Proposed E2B(R3) updates
      to align with ICH E2D(R1) guideline.
    • 18
      July 2003

      E2D

      Approval by the Steering Committee under Step 4 and
      recommendation for adoption to the three ICH
      regulatory bodies.

    • 12
      November 2003

      New
      Codification
      November
      2005
      E2D

      E2D

      Revision of E2D
      Code

      History

      E2D(R1) Endorsement by the Members of the ICH Assembly
      under Step 2 and release for public consultation.

    • Date

      New
      Codification

      5 February 2024

      E2D(R1)

      POST-APPROVAL SAFETY DATA:
      DEFINITIONS AND STANDARDS FOR MANAGEMENT AND
      REPORTING OF INDIVIDUAL CASE SAFETY REPORTS
      E2D(R1)
      ICH Consensus Guideline
      Table of Contents
      1.

    • The ICH E2D guideline provides guidance on definitions and standards for post-

      5

      approval individual case safety reporting, as well as good case management practices.

    • Detailed guidance on the

      9

      specific structure, format, standards, and data elements for transmitting Individual Case Safety

      10

      Reports (ICSRs) is provided in the ICH E2B guideline.

    • Guidance on periodic reporting of

      11

      aggregated safety data is covered in the ICH E2C guideline.

    • 12

      This guideline provides recommendations that are harmonised to the extent possible given

      13

      differences in post-market safety reporting requirements among ICH regions.

    • 25

      2.1.2

      Adverse Drug Reaction (ADR)

      26

      Adverse drug reactions, as defined by local and regional requirements, concern noxious and

      27

      unintended responses to a medicinal product.

    • 66

      Product labelling may include information related to ADRs for the pharmaceutical class to

      67

      which the medicinal product belongs.

    • In some cases, ?other observations? can occur

      78

      without any associated AEs/ADRs, while in other cases ?other observations? can occur with

      79

      an associated AE/ADR.

    • 84

      For the purpose of reporting, requirements in some regions refer only to ADRs, whereas other

      85

      regions refer to AEs.

    • 86

      Refer to local and regional requirements for specifications and requirements on the reporting

      87

      of AEs or ADRs to each Regulatory Authority.

    • 89

      2.2

      90

      An ICSR is a description of an AE/ADR or other observation in an individual patient at a specific

      91

      point of time.

    • Cases missing any of the above criteria do not qualify for reporting; due diligence

      99

      should be exercised to collect the missing criteria.

    • 6

      104

      An ICSR can be a description of at least one AE/ADR, or other observation (see Section 5.1.3,

      105

      Other Observations), or both.

    • Primary sources, often referred

      112

      to as ?reporters?, include healthcare professionals and consumers who provide facts about a case

      113

      to the MAH or regulatory authority.

    • 127

      2.7

      128

      A digital platform is the software and technology used to enable transmission of information

      129

      between users (see Section 4.3, Digital Platforms).

    • Expedited Report

      Primary Source

      Healthcare Professional (HCP)

      Consumer

      Digital Platform

      7

      130

      2.8

      131

      An organised data collection system (ODCS) is an activity that gathers data in a planned manner,

      132

      thereby enabling review to be performed.

    • MAHs should also follow the

      286

      advice in Section 5.1.2, Important Safety Findings, about communicating safety findings to

      13

      287

      regulatory authorities.

    • MAHs may conduct an MRP

      395

      using a digital platform; in this situation the ICH E2B data element value for ?MRP? should be

      396

      selected.

    • 564

      Terms (e.g., AEs/ADRs, indication, and medical conditions) in the narrative should be accurately

      565

      reflected in appropriate ICH E2B data elements.

    • 638

      Regulatory Authorities and MAHs should consider and manage duplicates when reviewing

      639

      pharmacovigilance data, as duplicates negatively impact signal detection.

    • 651

      Duplicate detection relies on good quality data and is generally based on similarities but should

      652

      take into account that information in ICSRs may differ between reporters.

2023 BrandSmart Awards Call for Entries Now Open

Retrieved on: 
Donnerstag, Januar 12, 2023

CHICAGO, Jan. 12, 2023 (GLOBE NEWSWIRE) -- Entries are now open for the marketing industry's prestigious BrandSmart Awards, an international award program organized and presented by the American Marketing Association Chicago .

Key Points: 
  • CHICAGO, Jan. 12, 2023 (GLOBE NEWSWIRE) -- Entries are now open for the marketing industry's prestigious BrandSmart Awards, an international award program organized and presented by the American Marketing Association Chicago .
  • The awards program recognizes the very best of brand marketing from around the globe.
  • Winners will be announced at the BrandSmart Awards ceremony on Wednesday, April 27, 2023, during the 21st annual BrandSmart Conference .
  • The BrandSmart Awards celebrate the brands and agencies behind the year's most remarkable brand marketing campaigns.

Asante Gold to Commence Trading on the Ghana Stock Exchange

Retrieved on: 
Mittwoch, Juni 29, 2022

VANCOUVER, British Columbia, June 29, 2022 (GLOBE NEWSWIRE) -- Asante Gold Corporation (CSE:ASE | GSE:ASG | FRANKFURT:1A9 | U.S.OTC:ASGOF) (Asante or the Company) is pleased to announce that further to its application for a secondary listing by introduction on the Main Market of the Ghana Stock Exchange (the GSE), the Company has received final approval from the Ghana Securities and Exchange Commission and the Ghana Stock Exchange to commence trading.

Key Points: 
  • VANCOUVER, British Columbia, June 29, 2022 (GLOBE NEWSWIRE) -- Asante Gold Corporation (CSE:ASE | GSE:ASG | FRANKFURT:1A9 | U.S.OTC:ASGOF) (Asante or the Company) is pleased to announce that further to its application for a secondary listing by introduction on the Main Market of the Ghana Stock Exchange (the GSE), the Company has received final approval from the Ghana Securities and Exchange Commission and the Ghana Stock Exchange to commence trading.
  • A copy of the *Prospectus SECONDARY LISTING BY INTRODUCTION ON THE GHANA STOCK EXCHANGE OF EXISTING 315,007,462 COMMON SHARES OF ASANTE GOLD CORPORATION is available on the Companys website indicated below.
  • Black Star Advisors Limited and Black Star Brokerage Limited acted as Arranger and Sponsoring Broker respectively to Asante in respect of the Listing on the Ghana Stock Exchange.
  • Asante is listed on the Canadian Securities Exchange, the Ghana Stock Exchange and quoted on the Frankfurt Stock Exchange.

AMA Chicago Announces Judges for 2022 BrandSmart Awards

Retrieved on: 
Freitag, Februar 18, 2022

CHICAGO, Feb. 18, 2022 (GLOBE NEWSWIRE) -- Recognizing the very best of brand marketing from around the globe, the 2022 BrandSmart Awards, presented by the American Marketing Association Chicago (AMA Chicago), announces an impressive list of judges for this years awards.

Key Points: 
  • CHICAGO, Feb. 18, 2022 (GLOBE NEWSWIRE) -- Recognizing the very best of brand marketing from around the globe, the 2022 BrandSmart Awards, presented by the American Marketing Association Chicago (AMA Chicago), announces an impressive list of judges for this years awards.
  • Guidelines for the 2022 BrandSmart Awards are available online ( https://amachicago.org/brandsmart-awards-guidelines/ ).
  • "Our judging panel represents some of the most creative minds in brand marketing," says Harvey Morris, 2022 BrandSmart Awards Chair.
  • They include:
    Winners will be announced at the BrandSmart Awards ceremony at the AON Ballroom at Navy Pier on Wednesday, April 27, 2022, at the 20th Annual BrandSmart Conference.

World's first automated 24/7 blood pressure monitor comes to the USA

Retrieved on: 
Dienstag, Januar 4, 2022

In the United States, nearly 50% of adults, about 116 million people, have high blood pressure.

Key Points: 
  • In the United States, nearly 50% of adults, about 116 million people, have high blood pressure.
  • Yet current measurement devices only capture a brief snapshot of overall blood pressure, and they are burdensome to use.
  • Aktiia'sOptical Blood Pressure Monitoring (OBPM) algorithms leverage optical sensors worn on the wrist and provide blood pressure values using photoplethysmography (PPG) toanalyzethe changing diameter of the arteries occurring at each heartbeat.
  • Founded in Switzerland in May 2018, Aktiia'steam has some of the world's leading scientific and technical experts in optical blood pressure monitoring.

2022 BrandSmart Awards Call for Entries Now Open

Retrieved on: 
Mittwoch, Dezember 15, 2021

CHICAGO, Dec. 15, 2021 (GLOBE NEWSWIRE) -- Entries are now open for the marketing industrys prestigious BrandSmart Awards.

Key Points: 
  • CHICAGO, Dec. 15, 2021 (GLOBE NEWSWIRE) -- Entries are now open for the marketing industrys prestigious BrandSmart Awards.
  • Guidelines for the 2022 BrandSmart Awards are available online (https://amachicago.org/brandsmart-awards-guidelines/).
  • "Unlike other marketing industry awards, The BrandSmart Awards honor brands that align both creativity and outcomes in their campaign, said Bonnie Massa, AMA Chicago Executive Director.
  • Winners will be announced at the BrandSmart Awards ceremony at the AON Ballroom at Navy Pier on Wednesday, April 27, 2022, at the 20th Annual BrandSmart Conference.