L1 intro

Question 1

What is the primary goal of reg affairs?

Answer 1

Protection of the consumer and/or wider society

Question 2

Why are certain products/services regulated by governmental oversight?

Answer 2

Due to their nature

Question 3

What do regulated products require?

Answer 3

Specialist knowledge to fully understand the implications of their use/ or misuse

Question 4

What are 4 highly regulated industries?

Answer 4

Financial services
Energy & utilities
Processing industries
Healthcare & life sciences

Question 5

What are regulations?

Answer 5

Complex systems of interrelated rules that govern a broad range of activities

Question 6

What are the most regulate activities?

Answer 6

Development, manufacturing, licencing & ongoing marketing of medicines

Question 7

What are the main objectives of the regulatory frameworks?

Answer 7

Products are safe & effective

Question 8

What do regulations must always have?

Answer 8

A legal basis

Question 9

What are laws?

Answer 9

Products of written statutes passed by legislative body in state/country/region concerned

Question 10

Why are regulations different to laws?

Answer 10

Set of standards & rules adopted by administrative agencies that have been charged with ensuring laws of the land are enforced

Question 11

What is a similarity with laws & regulations?

Answer 11

have to be Codified & officially published

Question 12

Why do laws/regulations have to be have to be Codified & officially published?

Answer 12

So all concerned stakeholders are ‘on notice’ in relation to what it is & what is not, regarded as legal in any given jurisdiction

Question 13

Do regulations have the same force as laws?

Answer 13

Yes - nominated agencies have enforcement powers

Question 14

What is regulatory science?

Answer 14

Application of scientific methods to improve the development, review & oversight of new drugs, biologics & devices that require regulatory approval

Question 15

What are 3 roles of reg affairs professional/

Answer 15

1. Ensure company is complying with regulations & laws
2. Advise employer on regulatory aspects that would affect business activities
3. Work in consultation with national, state and/or local regulatory agencies on specific issues affecting business operations

Question 16

What is compliance?

Answer 16

Doing things the way you should do them

Question 17

Why do we regulate healthcare products so heavily?

Answer 17

Not ordinary products
most consumer are not in a position to make an informed decision
Professional advice is needed

Question 18

What can you not forsee?

Answer 18

Emerging technologies
Unforeseen events
Fine balance between caution & stifling innovation

Question 19

What are regulatory changes driven by?

Answer 19

Catastrophe & tragedy

Question 20

What are pharmacopoeias?

Answer 20

First recorded date from egypt, greece, persia and was regarded as the earliest regulatory documents

Question 21

What year was the first london pharmacopeia issued?

Answer 21

1618

Question 22

What did first london pharmacopeia do?

Answer 22

Provided wardens of apothecaries to examine apothecaries & destroy all compounds unfaithfully made

Question 23

What did the Apothecaries Wares, Drugs & Stuffs Act 1540 state?

Answer 23

Ordered apothecaries to always prepare remedies in same way
prohibited green grocers from acting as apothecaries

Question 24

What did the Import Drugs Act 1848 state?

Answer 24

Mandatory inspections of imported drugs for quality & purity at the port of entry into US
Quality & purity defined in US pharmacopoeia

Question 25

What happened during the in dustrial revolution/

Answer 25

More pain, infectious diseases & depression

Question 26

What dye did Perkins discover?

Answer 26

Mauvine

Question 27

What was the Biologics Control Act?

Answer 27

1st law implementing federal regulation of specified products

Question 28

What did the Biologics Control Act set up?

Answer 28

The Bureau of Chemistry to keep an eye on composition of medicines & food

Question 29

Who was Chief Chemist at the Bureau of Chem?

Answer 29

Dr. Harvey W Wiley

Question 30

What was 'The Hygienic Table Trial'?

Answer 30

Structured clinical trials around food & food additives eg. Borax, Formaldehyde, Salicylic acid, Sulphuric acid

Question 31

What was the Pure Food and Drugs Act 1906?

Answer 31

Controlling adulteration or misbranding of foods, drugs, medicines & liquours Prohibited interstate transportation of these thing

Question 32

What toxic chemicals were banned for usage in food & drugs?

Answer 32

Borax, Formaldehyde, Salicylic acid, Sulphuric acid

Question 33

What happened in 1916 for Coca Cola?

Answer 33

Supreme Court told Coca Cola to reduce caffeine levels and pay all legal costs

Question 34

What happened in 1937 with Sulfanilimide elixir?

Answer 34

Contaminated with Diethylene glycol - 107 deaths (mostly children)

Question 35

What 3 things did the 1938 Federal Food, Drug & Cosmetic Act state?

Answer 35

1st legal stipulation of pre-market responsibilities for drug makers Pre-marketing approval requirements for all new drugs Directions for safe use now mandatory

Question 36

What was a problem with the 1938 Federal Food, Drug & Cosmetic Act?

Answer 36

No requirement for evidence of effectiveness

Question 37

What was Thalidomide (Gruenthal)?

Answer 37

Morning sickness drug in 1950s

Question 38

What was the consequence of Thalidomide use?

Answer 38

10,000 births were phocomelia & other defects in 46 countries

Question 39

Did the birth defects reach US?

Answer 39

Only 10 - FDA stopped its sale -> showed need for FDA

Question 40

What was the Drug Amendments Act of 1962?

Answer 40

Charged the FDA to evaluate & approve all new drug applications & stated that a new drug must be proven to be effective & safe

Question 41

What happened in 1963 in UK?

Answer 41

Committee of Safety of Drugs set up

Question 42

What was the Northwick Park Trial Disaster in 2006 in UK?

Answer 42

Immunomodulatory biologic (mAb) caused catastrophic systemic organ failure in 6 trial subjects

Question 43

What was the Bial Trial 2016?

Answer 43

Experimental FA amide hydrolase inhibitor developed by Bial-Portela for a range of different medical conditions

Question 44

What happened in the 1st in human trial in the Bial Trial?

Answer 44

Serious adverse effects occurred in 6 participants including death of 1 man