Regulatory Affairs

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Regulatory Affairs by Mind Map: Regulatory Affairs

1. Government/Regulatory Bodies

1.1. Written

1.1.1. Emails

1.1.2. Regulatory Dossier/File

1.1.3. Reports/Submissions

1.2. Verbal

1.2.1. Meetings/Conference

1.2.2. Presentations

1.2.3. Phone

1.3. Nonverbal

1.3.1. Body Language/Posture

1.3.2. Facial Expressions

1.3.3. Appearance/Attire

1.3.4. Eye Contact

1.3.5. Tone

1.4. Interpersonal

1.4.1. Familiarity

1.4.2. Feedback

1.4.3. Negotiation

2. Pharmacovigilance/Drug Safety

2.1. Written

2.1.1. Emails

2.1.2. Safety Reviews

2.1.3. Memos

2.1.4. Policies

2.2. Verbal

2.2.1. Meetings/Conferences

2.2.2. Presentations

2.2.3. Phone

2.3. Nonverbal

2.3.1. Body Language/Posture

2.3.2. Facial Expression

2.3.3. Eye Contact

2.3.4. Tone

2.4. Interpersonal

2.4.1. Familiarity/Rapport

2.4.2. Feedback

3. Quality Assurance

3.1. Written

3.1.1. Emails

3.1.2. Quality Reports/Reviews

3.1.3. GMP/GLP/GCP/Policies

3.1.4. Memos

3.2. Verbal

3.2.1. Meetings/Conference

3.2.2. Presentations

3.2.3. Phone

3.3. Nonverbal

3.3.1. Body Language/Posture

3.3.2. Facial Expression/Cues

3.3.3. Eye Contact

3.3.4. Tone

3.4. Interpersonal

3.4.1. Familiarity

3.4.2. Feedback

4. Medical Affairs

4.1. Written

4.1.1. Emails

4.1.2. Promotional/Technical/Educational Document Review

4.1.3. Memos

4.1.4. Late State/Postmarket Proposal

4.2. Verbal

4.2.1. Meetings/Conferences

4.2.2. Presentations

4.2.3. Phone

4.3. Nonverbal

4.3.1. Body Language/Posture

4.3.2. Facial Expression

4.3.3. Eye Contact

4.4. Interpersonal

4.4.1. Familiarity/Rapport

4.4.2. Feedback

5. Manufacturing

5.1. Written

5.1.1. Emails

5.1.2. Memos

5.1.3. Policies/Licence Documents/Regulations

5.1.4. Important Dates/Deadlines/Notices/Submissions

5.1.5. Dossier

5.2. Verbal

5.2.1. Meetings/Conferences

5.2.2. Presentations

5.2.3. Inspections

5.2.4. Phone

5.3. Nonverbal

5.3.1. Body Language/Posture

5.3.2. Facial Expression

5.3.3. Tone

5.3.4. Eye Contact

5.4. Interpersonal

5.4.1. Familiarity/Rapport

5.4.2. Feedback

5.4.3. Negotiation/Persuasion

6. Clinical/Nonclinical Research (Design, Premarket, CMC)

6.1. Written

6.1.1. Email

6.1.2. Policies/Licences/Regulations/Guidance Documents

6.1.3. Plan Proposal/Reviews

6.1.4. Memos/Deadlines/Dates

6.1.5. Clinical Trial Application (CTA) Support

6.2. Verbal

6.2.1. Meetings/Conference Calls

6.2.2. Presentations

6.2.3. Phone

6.3. Nonverbal

6.3.1. Body Language

6.3.2. Facial Expression

6.3.3. Eye Contact

6.4. Interpersonal

6.4.1. Familiarity/Rapport

6.4.2. Feedback

6.4.3. Negotiation/Persuasion

7. Marketing

7.1. Written

7.1.1. Marketing Permission Reviews/Support

7.1.2. Emails

7.1.3. Memos/Pamphlets

7.1.4. Social Media

7.1.5. Proposals/Regulation document

7.1.6. Websites

7.2. Verbal

7.2.1. Meetings/Conference

7.2.2. Presentations

7.2.3. Phone

7.3. Nonverbal

7.3.1. Body Language

7.3.2. Facial Expressions

7.3.3. Eye Contact

7.3.4. Appearance

7.4. Interpersonal

7.4.1. Familiarity/Rapport

7.4.2. Feedback

7.4.3. Negotiation

8. Legal

8.1. Written

8.1.1. Emails

8.1.2. Patents/Permissions/Licence/Certificate Documents

8.1.3. Memos/Pamphlets

8.1.4. Proposals/Renewals/Reviews

8.2. Verbal

8.2.1. Meetings/Conference

8.2.2. Presentations

8.2.3. Phone

8.3. Nonverbal

8.3.1. Body/Language

8.3.2. Facial Cues

8.3.3. Eye Contact

8.3.4. Appearance/Attire

8.4. Interpersonal

8.4.1. Familiarity/Rapport

8.4.2. Feedback

8.4.3. Negotiation/Persuasion

9. Project Management/Strategy

9.1. Written

9.1.1. Emails

9.1.2. Social Media

9.1.3. Dossier/Regulatory File

9.1.4. Deadlines/Updated Schedule,/Submissions

9.1.5. Proposals/Risk Management Strategies

9.1.6. Budgetary Memos

9.2. Verbal

9.2.1. Meetings/Conference

9.2.2. Presentations

9.2.3. Phone

9.3. Nonverbal

9.3.1. Body Language

9.3.2. Facial Expressions

9.3.3. Eye Contact

9.3.4. Appearance

9.4. Interpersonal

9.4.1. Familiarity/Rapport

9.4.2. Feedback

9.4.3. Negotiation

10. Human Resources

10.1. Written

10.1.1. Emails

10.1.2. Safety Reviews

10.1.3. Memos

10.1.4. Workplace/Conflict/Risk Policies

10.2. Verbal

10.2.1. Meetings/Conference

10.2.2. Presentations

10.2.3. Phone

10.3. Nonverbal

10.3.1. Body Language/Posture

10.3.2. Facial Expression

10.3.3. Eye Contact

10.3.4. Tone

10.4. Interpersonal

10.4.1. Familiarity/Rapport

10.4.2. Feedback

11. Communications

11.1. Written

11.1.1. Emails

11.1.2. Memos/Pamphlets

11.1.3. Social Media

11.1.4. Compliance/Regulation Documents

11.1.5. Websites

11.1.6. Label/Packaging Support (Print and Virtual)

11.2. Verbal

11.2.1. Meetings/Conference

11.2.2. Presentations

11.2.3. Phone

11.3. Nonverbal

11.3.1. Body Language

11.3.2. Facial Expressions

11.3.3. Eye Contact

11.3.4. Appearance

11.4. Interpersonal

11.4.1. Familiarity/Rapport

11.4.2. Feedback

11.4.3. Negotiation

12. General Public

12.1. Written

12.1.1. Emails/Respond to Inquiries

12.1.2. Pamphlets/Leaflets/Posters

12.1.3. Social Media

12.2. Verbal

12.2.1. Meetings/Conference/Event Interactions

12.2.2. Presentations

12.2.3. Phone

12.3. Nonverbal

12.3.1. Body Language/Posture

12.3.2. Facial Expression

12.3.3. Eye Contact

12.3.4. Tone

12.4. Interpersonal

12.4.1. Familiarity/Rapport

12.4.2. Feedback

12.4.3. Empathy

12.4.4. Listening

12.4.5. Negotiation/Persuasion